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Cataracts in adults: management. London: National Institute for Health and Care Excellence (NICE); 2017 Oct. (NICE Guideline, No. 77.)

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Cataracts in adults: management.

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12Preventing and managing complications

Modern phacoemulsification is one of the safest of all surgical procedures with a success rate of 92% or higher. However, complications can potentially occur at any stage of the patient journey. Whilst most are not serious, some complications may compromise visual outcome and negatively impact on patient expectation.

Although it occurs very rarely (around 1 in 1,000 cases) infectious endophthalmitis is considered one of the most serious complications of cataract surgery as, even when treated promptly, it can result in complete loss of vision of the eye. The risk of endophthalmitis can be reduced, but not totally eliminated, by a number of measures.

As it may be significantly associated with other unfavorable outcomes, the other complication which has received much attention in large-scale audits is posterior capsular rupture (PCR). For individual surgeons, having a PCR rate of approximately 2% or less is widely regarded as an indicator of surgical competence, although the probability of PCR for a particular cataract operation may be greatly increased by other factors including co-existing ocular and/or systemic comorbidity. Examples of the former include small pupil size, very dense cataract and poor zonular support.

Therefore, awareness of the likelihood of particular complications in an individual patient’s eye, and appropriate risk stratification, is widely acknowledged as an important component of careful preoperative assessment.

The purpose of this chapter is to address how potential complications in cataract surgery are best prevented and, if complications do occur, how these should be managed to optimise the most favourable visual outcome for the patient.

12.1. Interventions to prevent retinal detachment in people with myopia

12.1.1. Review question

  • What is the effectiveness of interventions (for example, prophylactic laser surgery) to prevent retinal detachment in people with myopia undergoing cataract surgery?

12.1.2. Introduction

The aim of this review was to determine whether interventions designed to prevent retinal detachment in people with myopia are effective. The review focused on identifying studies that fulfilled the conditions specified in Table 45. For full details of the review protocol, see Appendix C. The main outcome for this review was rates of retinal detachment.

Table 45. PICO criteria – preventing retinal detachment in people with myopia.

Table 45

PICO criteria – preventing retinal detachment in people with myopia.

Papers were excluded if they:

  • included animals, healthy eyes, other ocular conditions besides cataracts or mixed primary populations of people with different eye pathologies
  • reported studies conducted entirely in non-OECD countries
  • were not published in the English language.

For flow charts of study inclusion and exclusion, see Appendix K. For the list of excluded studies with reasons, see Appendix F.

12.1.3. Evidence review

In total, 1,121 references were found from a database search for this review question, and full-text versions of 16 citations that seemed potentially relevant to this topic were retrieved. No studies matched the review protocol for this question.

No relevant studies were identified in the update searches undertaken at the end of the guideline development process.

12.1.4. Health economic evidence

A literature search was conducted jointly for all review questions in this guideline by applying standard health economic filters to a clinical search for cataracts (see Appendix D). A total of 4,306 references was retrieved, of which 0 were retained for this review question. Health economic modelling was not prioritised for this review question.

12.1.5. Evidence statements

No evidence was identified for this review question.

12.1.5.1. Health economic evidence

No health economic evidence was identified for this review question.

12.1.6. Evidence to recommendations

Relative value of different outcomesThe committee agreed that rates of retinal detachment would be a relevant outcome, but were not surprised that no relevant evidence was identified, as it felt surgeons would be unlikely to undertake research in this area.
Trade-off between benefits and harmsThe committee agreed that surgeons would continue to treat as per current practice with possible referral to a vitreoretinal surgeon where possible. The use of cryoprobes was discussed but it was stated that they have inherent dangers such as retinal detachment. The committee agree that, whilst it is possible that there are methods of management that may be more or less effective in people with cataracts than in those without, the lack of evidence made it inappropriate to make specific recommendations.
Consideration of health benefits and resource useNo health economic evidence was identified for this review question and economic modelling was not prioritised. The committee agreed that, since its recommendation did not represent a difference from current practice, it would have no resource implications.
Quality of evidenceNo evidence was presented on which the committee could comment.
Other considerationsThe committee considered whether the lack of evidence indicated that a research recommendation was appropriate in this area. However, it agreed this did not represent a high priority for research, and that there were other areas of the guideline where it was more important to prioritise research, and therefore no such recommendation was made.

12.1.7. Recommendations

No recommendations were made for this review question.

12.2. Intraoperative pupil size management

12.2.1. Review question

  • What is the effectiveness of interventions to increase pupil size to improve visual outcomes and reduce complications during phacoemulsification cataract surgery?

12.2.2. Introduction

The aim of this review was to determine the effectiveness of interventions to increase pupil size to improve visual outcomes and reduce complications during phacoemulsification cataract surgery. The review focussed on identifying studies that fulfilled the conditions specified in Table 46. For full details of the review protocol, see Appendix C. The main outcomes for this review were visual acuity.

Table 46. PICO criteria for interventions to increase pupil size.

Table 46

PICO criteria for interventions to increase pupil size.

Papers were excluded if they:

  • were narrative reviews, case studies/reports, commentaries, editorials/letters or opinion pieces.
  • included animals, healthy eyes, other ocular conditions besides cataracts or mixed primary populations of people with different eye pathologies
  • were not published in the English language.

For flow charts of study inclusion and exclusion, see Appendix K. For the list of excluded studies with reasons, see Appendix F.

12.2.2.1. Deviations from protocol

When evidence on this question was discussed, the committee agreed that data on pupil size would be a useful outcome as a marker for the effectiveness of interventions, even though this was not specified in the original protocol. Only 1 included study presented data on pupil size, and these results are included below. No further evidence on pupil size was found on a re-run of the searches for this review question.

12.2.3. Evidence review

In total, 1,186 references were found from a database search for the review question. Full-text versions of 22 citations that seemed potentially relevant to this topic were retrieved and screened. Seven studies were included (5 randomised controlled trials and 2 case-controls; Espindola et al. 2012; Lorente et al. 2012; Moschos et al. 2011; Papaconstantinou et al. 2014; Shigleton et al. 2001 and 2006; Wilczynski et al. 2013).

No additional relevant studies were identified in the update searches undertaken at the end of the guideline development process.

The design of included studies is summarised in Table 47. Full details and results are found in the evidence tables (see Appendix E).

Table 47. Summary of included studies.

Table 47

Summary of included studies.

12.2.4. Health economic evidence

A literature search was conducted jointly for all review questions in this guideline by applying standard health economic filters to a clinical search for cataracts (see Appendix D). A total of 4,306 references was retrieved, of which 0 were retained for this review question. Health economic modelling was not prioritised for this review question.

12.2.5. Evidence statements

12.2.5.1. Best corrected visual acuity – DisCoVisc vs HPMC

Moderate-quality evidence from 1 RCT of 78 eyes could not detect a difference in best corrected visual acuity, 6 months postoperatively, in people given DisCoVisc or HPMC during cataract surgery.

12.2.5.2. Best corrected visual acuity – Viscoat vs VisThesia

Low-quality evidence from 2 RCTs containing 121 eyes could not detect a difference in best corrected visual acuity postoperatively or at 28 days postoperatively in people given Viscoat or VisThesia during cataract surgery.

12.2.5.3. Best corrected visual acuity – intracameral phenylephrine vs balanced salt solution

Low-quality evidence from 1 RCT of 84 eyes could not detect a difference in best corrected visual acuity, 3 months postoperatively, in people given intracameral phenylephrine or balanced salt solution during cataract surgery.

12.2.5.4. Mean best corrected visual acuity (decimal) – anterior chamber maintainer vs Vitrax

Very low-quality evidence from 1 case-control study of 66 eyes could not detect a difference in mean best corrected visual acuity (decimal), 3–6 weeks postoperatively, in people given an anterior chamber maintainer or Vitrax during cataract surgery.

12.2.5.5. Best corrected visual acuity – pupil stretching vs no stretching

Very low-quality evidence from 1 case-control study of 240 eyes could not detect a difference in best corrected visual acuity, 1 year postoperatively, in people given pupil stretching compared with those who were not given pupil stretching during cataract surgery.

12.2.5.6. Best corrected visual acuity – Malyugin Ring vs manual stretching

Moderate-quality evidence from 1 RCT of 40 eyes could not detect a difference in best corrected visual acuity - decimal, 1 month postoperatively, in people given either a Malyugin Ring or manual stretching of the pupil during cataract surgery.

12.2.5.7. Pupil size – intracameral phenylephrine vs balanced salt solution

Moderate-quality evidence from 1 RCT of 84 eyes found that people who were receiving tamsulosin and given intracameral phenylephrine obtained an increased pupil size after hydro-dissection compared with people given balanced saline solution during cataract surgery.

12.2.5.8. Health economic evidence

No health economic evidence was identified for this review question.

12.2.6. Evidence to recommendations

Relative value of different outcomesThe committee agreed that postoperative complications would be a relevant outcome, but that visual acuity outcomes would be unlikely to help answer this question as in non-randomised studies the aim of these interventions is to ensure people do not achieve worse outcomes than those with normal pupil sizes. Therefore, the committee noted that it would not expect to see any benefits when comparing these interventions in people with normal sized pupils. They noted that additional data on pupil size measurements would be of more interest and requested a deviation from the review question protocol to enable this.
Trade-off between benefits and harmsThe committee discussed the evidence and raised concerns that the outcomes measured in many trials did not directly answer important clinical questions, as they were often tested in a very broad population, which included people who would not be likely to receive these interventions in clinical practice. From the range of evidence presented, the committee agreed that 1 paper was of relevance to show how phenylephrine increased pupil size in people taking tamsulosin and at risk of floppy iris syndrome. From this evidence the committee agreed that, although the benefit was seen in patients receiving tamsulosin, the benefit would be generalisable to patients at risk of floppy iris syndrome. Thus a consider recommendation could be made regarding increasing the pupil size of patients at risk of floppy iris syndrome.
The committee noted that it would be useful to see evidence on the comparisons of drugs with devices but acknowledged that in most cases the surgeon will try a pharmacological intervention initially and only if this is not successful will revert to a mechanical one.
Consideration of health benefits and resource useNo health economic evidence was identified for this review question, and economic modelling was not prioritised. The committee agreed that, although the manual devices used to stretch pupils cost £50£100, their use was justified when compared with the alternative of failing to do the operation or causing intraoperative damage (e.g. PCR) which costs much more to correct. They further stated that such techniques are in common use and there is little alternative.
Quality of evidenceThe committee agreed that the overall quality of the evidence was low. They noted that the outcomes reported in the trials often did not help in addressing important clinical questions. The committee requested that the evidence on pupil size be added to the evidence base from the 1 paper in which it was reported.
Other considerationsNo other considerations were identified as part of this review question.

12.2.7. Recommendations

42.

Consider intracameral phenylephrine to increase pupil size in people at risk of floppy iris syndrome.

12.3. Interventions to reduce the impact of perioperative posterior capsule rupture

12.3.1. Review question

  • What is the effectiveness of interventions to reduce the impact of perioperative posterior capsule rupture?

12.3.2. Introduction

The aim of this review was to determine the effectiveness of interventions to reduce the impact of perioperative posterior capsule rupture. The review focused on identifying studies that fulfilled the conditions specified in Table 48. For full details of the review protocol, see Appendix C. The main outcome for this review was visual acuity.

Table 48. PICO inclusion criteria for interventions to reduce the impact of perioperative posterior capsule rupture.

Table 48

PICO inclusion criteria for interventions to reduce the impact of perioperative posterior capsule rupture.

Papers were excluded if they:

  • were narrative reviews, case studies/reports, commentaries, editorials/letters or opinion pieces.
  • included animals, healthy eyes, other ocular conditions besides cataracts or mixed primary populations of people with different eye pathologies
  • were not published in the English language.

For flow charts of study inclusion and exclusion, see Appendix K. For the list of excluded studies with reasons, see Appendix F.

12.3.3. Evidence review

In total, 1,984 references were found from a database search for this review question, and the full-text version of 1 citation that seemed potentially relevant to this topic was retrieved. No studies matched the review protocol for this question.

No relevant studies were identified in the update searches undertaken at the end of the guideline development process.

12.3.4. Health economic evidence

A literature search was conducted jointly for all review questions in this guideline by applying standard health economic filters to a clinical search for cataracts (see Appendix D). A total of 4,306 references was retrieved, of which 0 were retained for this review question. Health economic modelling was not prioritised for this review question.

12.3.5. Evidence statements

No evidence was identified for this review question.

12.3.5.1. Health economic evidence

No health economic evidence was identified for this review question.

12.3.6. Evidence to recommendations

Relative value of different outcomesThe committee agreed that evidence on long-term visual outcomes or rates of complications would be relevant for this review question.
Trade-off between benefits and harmsNo evidence was identified for this review question. However, the committee agreed that it was appropriate to make a consensus based recommendation that local areas should have a protocol in place to deal with posterior capsule rupture. They agreed this was necessary as inappropriate short-term management can lead to long term complications, and there were established elements of good quality care that all surgeons could reasonably be expected to follow.
The list of items such a protocol should include was decided by informal committee consensus. It was agreed that in the absence of evidence it would not be appropriate to specify details of what the protocol should say, but felt it was appropriate to include a set of minimum elements it should contain. The committee were aware of a number of existing examples of such protocols (for example, one developed by Moorfields Eye Hospital), which both demonstrated the feasibility of developing such a protocol, and provided a template that other centres could work from.
Consideration of health benefits and resource useNo economic evidence was identified for this review question, and economic modelling was not prioritised. The committee agreed that inappropriate management of posterior capsule ruptures had the potentially to lead to serious adverse events down the line, which would be likely to cost considerably more than the cost of appropriate management in the short-term. Therefore, the widespread adoption of appropriate protocols would likely be cost saving.
Quality of evidenceNo evidence was identified for this review question.
Other considerationsThe committee identified the Royal College of Ophthalmologists as a body that may be appropriate to develop consensus based guidelines on managing posterior capsule ruptures, to serve as a template for local protocols.

12.3.7. Recommendations

43.

When dealing with posterior capsule rupture, follow a protocol that covers:

  • removing vitreous from the wound and anterior chamber
  • minimising traction on the retina
  • removing lens fragments in the posterior chamber or vitreous cavity
  • removing soft lens matter
  • implications for any lens insertion.

12.4. Capsular tension rings

12.4.1. Review question

  • What is the effectiveness of capsular tension rings applied during phacoemulsification cataract surgery?

12.4.2. Introduction

The aim of this review was to determine the effectiveness of capsular tension rings applied during phacoemulsification cataract surgery. The review focussed on identifying studies that fulfilled the conditions specified in Table 49. For full details of the review protocol, see Appendix C. The main outcomes for this review were postoperative refraction, visual acuity, postoperative complications.

Table 49. PICO criteria for the effectiveness of capsular tension rings.

Table 49

PICO criteria for the effectiveness of capsular tension rings.

Papers were excluded if they:

  • were not randomised controlled trials.
  • included animals, healthy eyes, other ocular conditions besides cataracts or mixed primary populations of people with different eye pathologies
  • were not published in the English language.

For flow charts of study inclusion and exclusion, see Appendix K. For the list of excluded studies with reasons, see Appendix F.

12.4.3. Evidence review

In total, 1,186 references were found from a database search for the review question. Full-text versions of 17 citations that seemed potentially relevant to this topic were retrieved and screened. Seven randomised controlled trials were included (Alio et al. 2012; Bayraktar et al. 2001; Kocabora et al. (2007); Lee et al. 2002; Mastropasqua et al. 2013; Park et al. 2016 and Rohart et al. 2009). Two of these studies (Bayraktar and Kocabura) contained a population of people with pseudoexfoliation.

No additional relevant studies were identified in the update searches undertaken at the end of the guideline development process.

The design of included studies is summarised in Table 50. Full details and results are found in the evidence tables (see Appendix E).

Table 50. Summary of included studies for the effectiveness of capsular tension rings.

Table 50

Summary of included studies for the effectiveness of capsular tension rings.

12.4.4. Health economic evidence

A literature search was conducted jointly for all review questions in this guideline by applying standard health economic filters to a clinical search for cataracts (see Appendix D). A total of 4,306 references was retrieved, of which 0 were retained for this review question. Health economic modelling was not prioritised for this review question.

12.4.5. Evidence statements

12.4.5.1. Full population

12.4.5.1.1. Visual acuity

Low-quality evidence from 4 RCTs containing 356 eyes could not detect a clinically meaningful difference in corrected or uncorrected distance or near visual acuity in people given an intraocular lens fitted with or without a capsular tension ring during cataract surgery.

12.4.5.1.2. Cylindrical error

Moderate-quality evidence from 1 RCT containing 52 eyes could not detect a difference in cylindrical error in people given an intraocular lens fitted with or without a capsular tension ring during cataract surgery.

12.4.5.1.3. Corneal oedema

Low-quality evidence from 1 RCT containing 78 eyes could not differentiate the risk of developing postoperative corneal oedema in people given an intraocular lens fitted with or without a capsular tension ring.

12.4.5.1.4. Intraocular lens decentration

Moderate-quality evidence from 1 RCT containing 40 eyes found that people given an intraocular lens fitted with a capsular tension ring had reduced decentration compared with people given an intraocular lens fitted without a capsular tension ring 60 days after cataract surgery.

Moderate-quality evidence from 1 RCT containing 60 eyes could not detect a difference in decentration along the x-axis in people given an intraocular lens fitted with or without a capsular tension ring 360 days after cataract surgery.

High-quality evidence from 1 RCT containing 60 eyes found that people given an intraocular lens fitted with a capsular tension ring had increased decentration along the y-axis compared with people given an intraocular lens fitted without a capsular tension ring 360 days after cataract surgery.

12.4.5.2. People with pseudoexfoliation

Low-quality evidence from 2 RCTs containing 162 eyes found higher rates of IOLs being successfully placed in the bag and lower rates of zonular dehiscence in people with pseudoexfoliation fitted with a capsular tension ring after cataract surgery than those without.

12.4.5.3. Health economic evidence

No health economic evidence was identified for this review question.

12.4.6. Evidence to recommendations

Relative value of different outcomesThe committee agreed that postoperative refraction, visual acuity and postoperative complications would all be relevant outcomes. The committee also agreed that it would be useful to report successful IOL insertion and adverse event outcomes for people with pseudoexfoliation, as this is a group where the committee believe there is more likely to be a benefit from the use of capsular tension rings.
Of the postoperative complication outcomes, the committee agreed that corneal oedema was not as relevant as the others as this is unlikely to be impacted by the use of CTR.
Trade-off between benefits and harmsThe committee discussed the evidence and raised concerns that some surgeons may use capsular tension rings as an aid in their surgical technique. They also noted that 1 study used multifocal lenses whereas others used monofocal lenses. The committee agreed that if the surgeon decentres a standard monofocal lens it does not usually impact greatly on the patient’s vision but this is much more critical when either multifocal or toric lenses are implanted, due to the greater complexity of the lens. The committee also agreed that the evidence did not show a benefit from using capsular tension rings for general use and formulated a recommendation advising not to use them for routine, uncomplicated cataract surgery.
However, the committee noted there were benefits demonstrated in the subpopulation of people with pseudoexfoliation (lower rates of zonular dehiscence and a higher proportion of IOLs implanted successfully). The committee therefore agreed to make a separate recommendation for this sub-population to consider using capsular tension rings during cataract surgery. The committee agreed it could not make a stronger recommendation than this as the studies in this population were short-term, and there was therefore no data available on long-term outcomes.
Consideration of health benefits and resource useNo health economic evidence was identified for this review question and economic modelling was not prioritised. The committee noted that the cost of capsular tension rings in the NHS supply chain catalogue varies from around £40–80 per unit (with some outliers at either end of the scale), but that this may not be the price paid in practice as some areas will have confidential price discounts arranged wirth manufacturers. The committee agreed that capsular tension rings are relatively expensive and there would need to be clear benefits to justify their use in routine procedures, and evidence on adverse events in the subpopulation of people with pseudoexfoliation is needed to address the potential costeffectiveness of using capsular tension rings in these cases.
However, the evidence suggest that lower rates of zonular dehiscence and higher proportions of successful IOL implantation in this subgroup are associated with capsular tension ring use, and the committee therefore felt that a recommendation to consider their use was appropriate for two reasons. 1) the clinical benefit in this subgroup suggests that although a do not use recommendation was appropriate generally, it did not want to rule out their use in cases of pseudoexfoliation and 2) It would allow further, longer-term evidence to be collated that would enable a thoroughgoing cost-effectiveness analysis of CTRs to be undertaken.
Quality of evidenceThe committee agreed that the overall quality of the evidence was reasonable. They were interested in the lower vitrectomy rates reported in patients receiving a capsular tension ring. Vitrectomies have costs and associated complication rates, such that a reduction in vitrectomy rates implies a meaningful gain for patients. The committee also agreed that 0.1mm or less decentration of the lens postoperatively is unlikely to be meaningful.
The committee noted that as pseudoexfoliation occurs in around 15% of patients, it would have been helpful to have seen evidence on lens decentration in patients with the condition but accepted that there were no studies reporting this outcome in the required population. The committee formulated a research recommendation in order to answer this, and assess the long-term effectiveness of capsular tension rings in this group.
Other considerationsNo other considerations were identified as part of this review question.

12.4.7. Recommendations

44.

Do not use capsular tension rings in routine, uncomplicated cataract surgery.

45.

Consider using capsular tension rings for people with pseudoexfoliation.

12.4.8. Research recommendations

14.

What is the long-term effectiveness of capsular tension rings in people with pseudoexfoliation undergoing cataract surgery?

Why is this important?

Evidence indicates that there are benefits from using capsular tension rings in people with pseudoexfoliation such as lower rates of zonular dehiscence and a higher proportion of IOLs being implanted successfully but these were only measured a short time after surgery. Well conducted randomised controlled trials in this population would help to show whether these benefits continued in the long term and so inform future recommendations on their use.

12.5. Interventions to prevent endophthalmitis

12.5.1. Review question

  • What is the effectiveness of prophylactic antiseptics and antibiotics to prevent endophthalmitis after cataract surgery?

12.5.2. Introduction

The aim of this review was to evaluate the effectiveness of the following interventions to prevent endophthalmitis after cataract surgery:

  • prophylactic antiseptics (for example, topical iodine)
  • prophylactic antibiotics

The review on antibiotics was undertaken by the Cochrane Eyes and Vision Group, in collaboration with the NICE Internal Clinical Guidelines Team. For the purposes of this guideline, papers from the Cochrane review were excluded if they were conducted in non-OECD countries.

The review focused on identifying studies that fulfilled the conditions specified in Table 51. For full details of the review protocol, see Appendix C.

Table 51. PICO inclusion criteria for the effectiveness of prophylactic antiseptics and antibiotics to prevent endophthalmitis.

Table 51

PICO inclusion criteria for the effectiveness of prophylactic antiseptics and antibiotics to prevent endophthalmitis.

Randomised controlled trials (RCTs) and systematic reviews of RCTs were included if they evaluated antiseptics, pre-, intra-, or postoperative antibiotic prophylaxis for acute endophthalmitis after cataract surgery. Papers were excluded if they:

  • were narrative reviews, case studies/reports, case series, reliability studies, diagnostic accuracy studies, non-comparative studies
  • included animals, healthy eyes, other ocular conditions besides cataracts or mixed primary populations of people with different eye pathologies
  • reported studies conducted entirely in non-OECD countries
  • were not published in the English language.

For the list of excluded studies with reasons, see Appendix F.

12.5.3. Evidence review

Two separate systematic searches were conducted (see Appendix D) – 1 for prophylactic antiseptics and 1 for prophylactic antibiotics to prevent endophthalmitis after cataract surgery.

Electronic literature searches for RCTs of cataract surgery that evaluated giving prophylactic antiseptics to prevent endophthalmitis identified 356 potentially relevant references. After removing duplicates the references were screened on their titles and abstracts and full papers of 6 references were obtained and reviewed against the inclusion and exclusion criteria in the review protocol (see Appendix C). However, none of these references met the inclusion criteria for this review, for reasons such as not being a randomised-control trial or not reporting an outcome of interest. No references on prophylactic antiseptics were therefore included in this review.

As of 25 October 2012, electronic literature searches for RCTs of cataract surgery that evaluated giving antibiotics shortly before, during, or immediately after surgery to prevent endophthalmitis identified 491 potentially relevant titles and abstracts for this review (Gower 2013). After duplicate independent abstract review, 12 references were assessed at the full-text level, of which 7 were excluded and 5 were included in the review. The 5 references reported 2 studies. A review of references that cited the included studies and the reference lists of included studies identified 1 additional record that was excluded after full-text assessment.

An update search in April 2016 identified 123 new records. The Cochrane information specialist removed 34 duplicate records and the remaining 89 reports were screened. Overall, 84 references were excluded after reading the abstracts and full papers of 5 references were obtained for further assessment. However, none met the eligibility criteria for this review and were therefore excluded.

In total 2 references on prophylactic antibiotics to prevent endophthalmitis after cataract surgery were therefore included in this review.

No additional relevant studies were identified in the update searches undertaken at the end of the guideline development process.

12.5.3.1. Description of included studies

Sobaci et al. (2003) was conducted in Turkey and compared antibiotics (vancomycin and gentamicin) in balanced salt solution (BSS) irrigating infusion fluid with BSS-only irrigating infusion fluid in 644 eyes of 640 participants. All were treated with ofloxacin and diclofenac sodium 4 times on the day before surgery. Povidone iodine was used for antisepsis at the time of surgery and a solution of ofloxacin, dexamethasone and indomethasine was given postoperatively. Follow-up was for 6 weeks after the operation. Since the incidence of endophthalmitis following cataract surgery is low (the study authors reported the rate of postoperative endophthalmitis at their institution was 0.109%) and because only 644 eyes were included in the study (with less than 1 eye expected to be affected), the study lacked sufficient power to detect valid differences between treatments.

ESCRS 2007, conducted at multiple sites throughout Europe and Turkey, implemented a 2-by-2 factorial design to evaluate intracameral cefuroxime injected at the end of surgery and topical levofloxacin given immediately preoperatively (within 1 hour of surgery) and up to 15 minutes following surgery in 16,603 participants. In a factorial design studying 2 drugs or procedures that are expected to act independently, treatment arms were allocated such that both drugs can be evaluated alone and in combination.

In ESCRS 2007, the 2 interventions studied were intracameral cefuroxime and topical levofloxacin. One group received only intracameral cefuroxime, 1 group received only topical levofloxacin, 1 group received both intracameral cefuroxime and topical levofloxacin, and 1 group received neither intervention. Povidone iodine was used for antisepsis at the time of surgery and topical levofloxacin was given to all participants starting the morning after surgery. Follow-up was for 6 weeks after the operation.

The included studies are summarised in Table 52; full details are found in the evidence tables (see Appendix E).

Table 52. Summary of included studies for the effectiveness of prophylactic antiseptics and antibiotics to prevent endophthalmitis.

Table 52

Summary of included studies for the effectiveness of prophylactic antiseptics and antibiotics to prevent endophthalmitis.

12.5.4. Health economic evidence

A literature search was conducted jointly for all review questions in this guideline by applying standard health economic filters to a clinical search for cataracts (see Appendix D). A total of 4,306 references was retrieved, of which 0 were retained for this review question. Health economic modelling was not prioritised for this review question.

12.5.5. Evidence statements

12.5.5.1. Endophthalmitis rates

12.5.5.1.1. Culture-proven cases

Low- to moderate-quality evidence from 1 RCT containing 16,603 participants could not detect a clinically meaningful difference in the risk of culture-proven postoperative endophthalmitis at 6 weeks between topical levofloxacin alone and placebo drops, or between eyes treated with intracameral cefuroxime alone and eyes treated with topical levofloxacin alone, or combined intracameral cefuroxime and topical levofloxacin compared with eyes treated with topical levofloxacin alone.

Very low-quality evidence from 1 RCT containing 640 participants found no meaningful difference in the risk of culture-proven postoperative endophthalmitis at 6 weeks between irrigation with balanced salt solution with vancomycin and gentamicin and balanced salt solution alone.

12.5.5.1.2. Clinically diagnosed cases

High-quality evidence from 1 RCT containing 16,603 participants found that intracameral cefuroxime injections, with or without topical levofloxacin, compared with no prophylaxis is associated with a clinically meaningfully reduced risk of clinically diagnosed postoperative endophthalmitis.

Moderate-quality evidence from 1 RCT containing 16,603 participants found that combined intracameral cefuroxime and topical levofloxacin, compared with topical levofloxacin alone, is associated with a clinically meaningfully reduced risk of clinically diagnosed postoperative endophthalmitis.

12.5.5.2. Best corrected distance visual acuity (BCVA)

No evidence for BCVA was identified.

12.5.5.3. Adverse events

No evidence for adverse events was identified.

12.5.5.4. Health economic evidence

No health economic evidence was identified for this review question.

12.5.6. Evidence to recommendations

Relative value of different outcomesThe committee agreed that both clinically diagnosed and cultureproven endophthalmitis rates were useful outcomes, and that an effect on either outcome would be meaningful.
Trade-off between benefits and harmsThe committee was not surprised that there were no RCT evidence for antiseptics as they are used extensively as part of standard surgical practice to prevent infection (in both cataract and other types of surgery). It may therefore be unethical not to offer people antiseptics or to randomise people to a pure placebo group in research trials. The routine use of antiseptic prophylaxis was also confirmed in the 2 RCTs of antibiotics, where antiseptics were used as prophylaxis at the time of surgery. The committee agreed that, although there is no evidence on the use of antiseptic prophylaxis, a strong (‘use’) recommendation should still be made due to the widespread practice. It also agreed that, since there was no evidence to suggest antiseptic use should be any different in people with cataract surgery, the use should be in line with standard general surgical practice.
For the study by ESCRS, the committee discussed the evidence for both clinically diagnosed and culture-proven endophthalmitis, where significant findings were only seen in the clinically diagnosed endophthalmitis with intracameral cefuroxime and in none of the culture-proven cases. The committee discussed and agreed that clinically diagnosed cases may not always be culture-positive. Examples of possible reasons for this could be that the culture techniques used are not sensitive enough or the sample taken is not large enough to have captured an adequate amount of the bacteria to grow on the culture plate. The committee was therefore not concerned about the non-significant results for culture-proven endophthalmitis.
The committee agreed that, as a significant reduction in clinically diagnosed endophthalmitis with intracameral cefuroxime was evident in the evidence and from the clinical experience of committee members, intracameral injection is also more comfortable for the patient, a strong (‘use’) recommendation should be made. However, the committee stressed the importance of providing the correct concentration of intracameral antibiotics to prevent toxicity. Accurate dilution of the drug is therefore essential. The committee therefore agreed that dilution of antibiotics should not take place in theatre, where the risk of errors being made is considerably higher. The antibiotic solution should either be commercially prepared (reconstituted) or prepared in a designated pharmacy (which may be within the hospital).
Consideration of health benefits and resource useAs antibiotics and antiseptics are commonly used there are not expected to be any significant resource implications from the recommendations made, especially when compared with the significant costs incurred in the treatment of endophthalmitis.
Quality of evidenceThe committee agreed that the ESCRS study was well-designed and executed but for the Sobaci et al. (2003) study, the committee had some concern that excluding people where the surgical technique was modified may have excluded people at the highest risk of infection. They also noted the small study sample size in the Sobaci et al. study and agreed that the trial would need to be much larger in order to provide any meaningful evidence.
The committee discussed the lack of evidence on postoperative antibiotics, and that this may be due to the fact that they are provided as part of standard good clinical practice in the UK (although there is wide variation in practice around the world). In addition, the committee recognised that patients are invariably receiving other drops (e.g. steroids), which are likely provided in combination with postoperative antibiotic drops and often in a single drop product. For this reason, and in the absence of evidence, the committee agreed that it would be inappropriate to make a recommendation for postoperative antibiotics at this stage but instead it would useful to make a recommendation for future research.
Other considerationThe committee discussed the risk of antibiotic resistance but agreed that the risk is low here because the doses are so low, and none of the commonly used antibiotics are ones that are critical for use in other situations. The committee was therefore not concerned about any antibiotic resistance issues as a result of the recommendations made.

12.5.7. Recommendations

46.

Use preoperative antiseptics in line with standard surgical practice.

47.

Use intracameral cefuroxime during cataract surgery to prevent endophthalmitis.

48.

Use commercially prepared or pharmacy-prepared intracameral antibiotic solutions to prevent dilution errors.

12.5.8. Research recommendation

15.

What is the effectiveness of postoperative antibiotic drops to reduce rates of endophthalmitis after cataract surgery?

Why this is important

There is a lack of evidence on postoperative antibiotics to reduce rates of endophthalmitis, which may be because they are provided as part of standard good clinical practice in the UK. In addition, it is recognised that patients are invariably receiving other drops (for example, steroids), which are likely to be offered in combination with postoperative antibiotic drops, and often in a single-drop product. Well-conducted randomised controlled trials of postoperative antibiotics in people having cataract surgery would help add to the evidence base and so inform future recommendations on their use.

12.6. Interventions to prevent cystoid macular oedema

12.6.1. Review question

  • What is the effectiveness of prophylactic topical corticosteroids and/or NSAIDs to prevent inflammation and cystoid macular oedema after phacoemulsification cataract surgery?

12.6.2. Introduction

This review was undertaken by the Cochrane Eyes and Vision Group, in collaboration with the NICE Internal Clinical Guidelines Team. For the purposes of this guideline, papers from the Cochrane review were excluded if they were conducted in non-OECD countries, did not use phacoemulsification or compared oral corticosteroids and/or NSAIDs with no treatment or another intervention within the same class.

The aim of this review was to evaluate the effectiveness of prophylactic topical corticosteroids and/or non-steroidal anti-inflammatory drugs (NSAIDs) to prevent inflammation and cystoid macular oedema following phacoemulsification cataract surgery. Studies where no active intervention was given were not included, as these were deemed not to be representative of current practice.

The review focused on identifying studies that fulfilled the conditions specified in Table 53. For full details of the review protocol, see Appendix C.

Table 53. PICO inclusion criteria for the effectiveness of prophylactic topical corticosteroids and/or NSAIDs to prevent inflammation and cystoid macular oedema.

Table 53

PICO inclusion criteria for the effectiveness of prophylactic topical corticosteroids and/or NSAIDs to prevent inflammation and cystoid macular oedema.

Randomised controlled trials (RCTs) and systematic reviews of RCTs were included if they compared topical corticosteroids and/or NSAIDs with another relevant intervention. Papers were excluded if they:

  • were narrative reviews, case studies/reports, case series, reliability studies, diagnostic accuracy studies, non-comparative studies
  • included animals, healthy eyes, other ocular conditions besides cataracts or mixed primary populations of people with different eye pathologies
  • compared oral corticosteroids and/or NSAIDs with no treatment or another intervention within the same class
  • reported studies conducted entirely in non-OECD countries
  • were not published in the English language.

12.6.3. Evidence review

A systematic search was conducted (see Appendix D), which identified 928 references. After removing duplicates the references were screened on their titles and abstracts and full papers of 62 references were obtained and reviewed against the inclusion and exclusion criteria in the review protocol (see Appendix C). From examining reference lists of the retrieved studies, 2 additional references were identified as being potentially relevant.

Overall, 46 references were excluded as they did not meet the eligibility criteria, for reasons such as not being a randomised-control design or not assessing an included intervention. A detailed list of excluded studies and reasons for their exclusion is provided in Appendix F. The remaining 18 studies were identified as being relevant and were therefore included in this review.

No additional relevant studies were identified in the update searches undertaken at the end of the guideline development process.

12.6.3.1. Description of included studies

The included studies are summarised in Table 54; full details are found in the evidence tables (see Appendix E). All 18 identified primary studies were randomised controlled trials, 13 comparing NSAIDs plus steroids versus steroids alone, and 6 comparing NSAIDs versus steroids (1 RCT had 3 treatment arms – NSAIDs plus steroids, NSAIDs and steroids).

Table 54. Summary of included studies for the effectiveness of prophylactic topical corticosteroids and/or NSAIDs to prevent inflammation and cystoid macular oedema.

Table 54

Summary of included studies for the effectiveness of prophylactic topical corticosteroids and/or NSAIDs to prevent inflammation and cystoid macular oedema.

12.6.4. Health economic evidence

A literature search was conducted jointly for all review questions in this guideline by applying standard health economic filters to a clinical search for cataracts (see Appendix D). A total of 4,306 references was retrieved, of which 0 were retained for this review question. Health economic modelling was not prioritised for this review question.

12.6.5. Evidence statements

12.6.5.1. Inflammation

Very low-quality evidence from 5 RCTs containing 346 participants found no meaningful difference between NSAIDs and steroids in controlling postoperative inflammation (measured as flare [photons/ms]) after cataract surgery.

Low quality-evidence from 1 RCT containing 47 participants indicates that, compared with steroids alone, NSAIDs plus steroids are more effective in controlling postoperative inflammation (measured as flare [photons/ms]) after cataract surgery.

Very low-quality evidence from 2 RCTs containing 198 participants found no meaningful difference between NSAIDs plus steroids and steroids alone in the risk of postoperative inflammation (measured as number of events) after cataract surgery.

12.6.5.2. Cystoid macular oedema

Low-quality evidence from 4 RCTs containing 291 participants indicates that, compared with steroids, NSAIDs are associated with a lower risk of cystoid macular oedema after cataract surgery.

Low-quality evidence from 9 RCTs containing 1,388 participants indicates that, compared with steroids alone, NSAIDs plus steroids are associated with a lower risk of cystoid macular oedema after cataract surgery.

12.6.5.2.1. Population with diabetic retinopathy

Moderate-quality evidence from 2 RCTs containing 409 participants with diabetic retinopathy indicates that, compared with steroids alone, NSAIDs plus steroids are associated with a lower risk of cystoid macular oedema after cataract surgery.

12.6.5.3. Best corrected distance visual acuity (BCVA)

Very low-quality evidence from 3 RCTs containing 220 participants found no meaningful difference between NSAIDs and steroids on the improvement of BCVA [logMAR] after cataract surgery.

Very low-quality evidence from 7 RCTs containing 782 participants found no meaningful difference between NSAIDs plus steroids and steroids alone on the improvement of BCVA [logMAR] after cataract surgery.

12.6.5.3.1. Population with diabetic retinopathy

Low-quality evidence from 2 RCTs containing 405 participants with diabetic retinopathy found a lower proportion of people treated with NSAIDs plus steroids lost at least 5 letters of BCVA, compared with those treated with steroids alone.

Very low-quality evidence from 2 RCTs containing 404 participants with diabetic retinopathy found no meaningful difference between NSAIDs plus steroids and steroids alone on the improvement of mean BCVA [letters] after cataract surgery.

12.6.5.4. Poor vision due to cystoid macular oedema (CMO)

Very low-quality evidence from 3 RCTs containing 679 participants found no meaningful difference between NSAIDs plus steroids and steroids alone in the risk of poor vision due to CMO after cataract surgery.

12.6.5.5. Adverse events

Very low-quality evidence from 5 RCTs containing 346 participants found no meaningful difference between NSAIDs and steroids in the risk of adverse events.

Very low-quality evidence from 10 RCT containing 1,467 participants found no meaningful difference between NSAIDs plus steroids and steroids alone in the risk of adverse events.

12.6.5.6. Network meta-analyses

Low-quality evidence from a network meta-analysis of 5 RCTs containing 370 participants found that NSAIDs plus steroids are more effective in controlling postoperative inflammation after cataract surgery compared with steroids alone.

Low-quality evidence from a network meta-analysis of 12 RCTs containing 1,656 participants found that, compared with steroids alone, NSAIDs plus steroids and NSAIDs alone both lower the risk of cystoid macular oedema after cataract surgery.

Low-quality evidence from a network meta-analysis of 9 RCTs containing 979 participants could not differentiate the improvements in BCVA after cataract surgery between people receiving steroids, NSAIDs or NSAIDs plus steroids.

12.6.5.7. Health economic evidence

No health economic evidence was identified for this review question.

12.6.6. Evidence to recommendations

Relative value of different outcomesThe committee considered that the measures of postoperative CMO (measured by OCT), visual acuity and inflammation were all important effectiveness outcomes. However, the committee noted that, in the included studies, inflammation was measured using laser flare photometry and because this is not used in current clinical practice, it reduces its relative value in this review.
Trade-off between benefits and harmsThe committee noted that the evidence was only available in a lowrisk (routine) population and that majority of the studies had excluded the higher-risk population, such as people at high risk of inflammation or those with uveitis, who have a predisposition for CMO. The committee discussed whether the evidence could be generalised and applied to the high-risk population and it agreed that, based on committee members’ clinical experience, they would expect to see similar overall relative benefits in both groups (although absolute effects would be greater, owing to higher underlying event rates), despite the lack of evidence in the high-risk group.
The committee also discussed the use of topical steroids and NSAIDs in current clinical practice and agreed that both groups of drugs are routinely used in prophylaxis and treatment. In particular, the committee highlighted that NSAIDs with or without steroids are commonly administered to people with diabetes and for treatment of symptomatic CMO, in which setting they have been shown to be effective. However, the committee also acknowledged that some clinicians may worry about prescribing NSAIDs due to side effects such as stinging, burning, and conjunctival hyperaemia which could potentially lead to poor compliance. These types of side effects were also reported in some of the included studies.
Discussing the evidence, the committee agreed that, although NSAIDs with or without steroids were shown to be better than steroids alone in reducing the risk of CMO, in people with a low preoperative risk of CMO, the effects shown would not be sufficient to justify the routine use of combination NSAID and steroid therapy for all people undergoing cataract surgery, particularly given the low quality of much of the evidence base. Hence, based on the evidencebase and the current clinical practice of providing either topical steroids and/or NSAIDs as prophylaxis to people undergoing cataract surgery, the committee agreed to make a recommendation to offer topical steroids and/or NSAIDs for all people following cataract surgery.
The committee discussed whether to make a specific recommendation for the high-risk population. From the knowledge and clinical experience of committee members, combination therapy is commonly used in people who are at higher risk of CMO. The majority of the studies intentionally excluded people who are at high risk, and therefore the only relevant evidence came from populations of people with diabetic retinopathy. The committee agreed that it was reasonable to extrapolate this evidence to other populations at high preoperative risk of CMO, such as people with other retinal disease or uveitis, and therefore a ‘consider’ recommendation was made for combination therapy in people at high risk of CMO.
No evidence was identified on the timing/duration of treatment, and therefore the committee agreed it was not possible to make any recommendations on this topic. The committee also discussed whether to make a recommendation on dosages; however, due to no evidence being available on what the correct/appropriate dosage should be, it agreed not to make any recommendations.
Consideration of health benefits and resource useThe committee noted that, while the resource implications of offering combination treatment over monotherapy were small in any individual case, a recommendation for routine dual therapy in every cataract surgery would amount to a consequential increase in costs.
Therefore, the committee agreed this supported its recommendation that combination therapy is not routinely necessary in people at low risk of CMO. In high-risk populations, the extra resources used were felt to be justified, as a significant reduction in rates of CMO would have savings in terms of treatment which would comfortably offset the costs of prophylaxis.
Quality of evidenceThe committee discussed that it may be difficult to generalise the evidence to the most common settings in the UK because the majority of the evidence was only available in populations at low preoperative risk for CMO. Nevertheless, the committee agreed that it would expect to see a similar overall relative response in both groups.
The committee noted that the evidence presented consisted of comparisons between active treatments, rather than comparisons to no treatment or placebo. However, it agreed that it would be considered unethical not to give some prophylactic treatment, and therefore agreed this omission did not adversely affect the quality of the evidence base.
Other considerationsThe committee noted that ongoing research is taking place in this area (as identified from trial registries as part of the included Cochrane review) and therefore agreed that, at this point, there is no need for any research recommendation.

12.6.7. Recommendations

49.

Consider topical steroids in combination with non-steroidal anti-inflammatory drugs (NSAIDs):

  • after cataract surgery for people at increased risk of cystoid macular oedema, for example, people with diabetes or uveitis
  • to manage cystoid macular oedema.

50.

Offer topical steroids and/or NSAIDs after cataract surgery to prevent inflammation and cystoid macular oedema.

12.7. Managing cystoid macular oedema

12.7.1. Review question

  • What is the effectiveness of interventions used to manage cystoid macular oedema following cataract surgery?

12.7.2. Introduction

The aim of this review was to determine the effectiveness of interventions used to manage cystoid macular oedema (CMO) following cataract surgery. The review focussed on identifying studies that fulfilled the conditions specified in Table 55. For full details of the review protocol, see Appendix C. The main outcomes for this review were visual acuity and time to resolution of macular oedema.

Table 55. PICO criteria for managing cystoid macular oedema.

Table 55

PICO criteria for managing cystoid macular oedema.

Papers were excluded if they:

  • were not randomised controlled trials.
  • included animals, healthy eyes, other ocular conditions besides cataracts or mixed primary populations of people with different eye pathologies
  • were not published in the English language.

For flow charts of study inclusion and exclusion, see Appendix K. For the list of excluded studies with reasons, see Appendix F.

12.7.3. Evidence review

In total, 2,539 references were found from a database search for the review question. Full-text versions of 25 citations that seemed potentially relevant to this topic were retrieved and screened. Three randomised controlled trials were included (Heier et al., 2000, Rho, 2003 and Singal et al., 2004).

No additional relevant studies were identified in the update searches undertaken at the end of the guideline development process.

The design of included studies is summarised in Table 56. Full details and results are found in the evidence tables (see Appendix E).

Table 56. Summary of included studies for managing cystoid macular oedema.

Table 56

Summary of included studies for managing cystoid macular oedema.

The initial protocol within the Heier et al. (2000) study had an additional treatment arm that was placebo-only. The protocol was not approved in this form. The ethics board believed it was unethical not to treat patients with acute CMO (despite the possibility of spontaneous improvement) because they believed treatment with some form of anti-inflammatory was considered to be standard care.

12.7.4. Health economic evidence

A literature search was conducted jointly for all review questions in this guideline by applying standard health economic filters to a clinical search for cataracts (see Appendix D). A total of 4,306 references was retrieved, of which 0 were retained for this review question. Health economic modelling was not prioritised for this review question.

12.7.5. Evidence statements

12.7.5.1. Final visual acuity ≥ 20/40

Low-quality evidence from 1 RCT containing 26 participants could not differentiate the proportion of people, who achieved visual acuity equivalent to, or greater than, 20/40, between those who received prednisolone, ketorolac or a combination of ketorolac plus prednisolone, after cataract surgery.

12.7.5.2. Elimination of cystoid macular oedema

Low-quality evidence from 1 RCT containing 34 participants could not differentiate the proportion of people who had their cystoid macular oedema resolved, between those who received ketorolac or diclofenac solution after cataract surgery.

Low-quality evidence from 1 RCT containing 34 participants could not detect a difference in the average time taken, in weeks, for cystoid macular oedema to be resolved, for those people who received ketorolac or diclofenac solution after cataract surgery.

12.7.5.3. Snellen equivalent visual acuity

Low-quality evidence from 1 RCT containing 26 participants could not detect a difference in Snellen equivalent visual acuity, for those people who received ketorolac or ketorolac plus prednisolone after cataract surgery.

12.7.5.4. Health economic evidence

No health economic evidence was identified for this review question.

12.7.6. Evidence to recommendations

Relative value of different outcomesThe committee agreed that visual acuity and time to resolution of CMO would be relevant outcomes. They also noted that some cases of measurable CMO would spontaneously resolve without the need for further treatment, and this needed to be considered when interpreting the results.
Trade-off between benefits and harmsFrom their clinical experience, the committee agreed it was likely that combination treatment with both steroids and NSAIDs would be more effective than monotherapy with either alternative. The committee noted that in the trials there was no significant improvement in visual acuity with combination treatment, but the trials contained very small numbers of individuals, with the point estimates in favour of combination treatment. The limited evidence led to the committee to agree that it would be reasonable to make a “consider” recommendation for the use of combination therapy for the treatment of CMO.
Consideration of health benefits and resource useNo health economic evidence was identified for this review question and economic modelling was not prioritised, However, the committee agreed that since only a small proportion of people will develop CMO requiring treatment after cataract surgery, the overall resource implications of this recommendation are likely to be minimal, particularly as in many parts of the country the use of combination treatment is already common practice.
Quality of evidenceThe committee agreed that the quality of the evidence was low, highlighting the low number of patients within all the included studies, meaning that it was very unlikely any significant effects would be detected.
The committee noted that 1 study reported the average number of people with a final visual acuity ≥ 20/40 as being statistically significant but that the authors did not report their statistical analysis clearly, making it difficult to use in helping to formulate recommendations.
Other considerationsThe committee noted that evidence was only found for the use of steroids and NSAIDs, and no evidence was found for the other interventions specified in the protocol. They therefore agreed that further research would be of benefit, leading to the formulation of a research recommendation for the postoperative treatment of patients with CMO.

12.7.7. Recommendations

The recommendations made for this review question are presented in section 12.6.7.

12.7.8. Research recommendations

16.

What is the most effective postoperative medical management for cystoid macular oedema?

Why this is important

Although there is evidence for using steroids and non-steroidal anti-inflammatory drugs (NSAIDs) in treating cystoid macular oedema, no evidence has been identified for interventions such as acetazolamide, steroid-based anti-inflammatory drugs or intraocular anti-vascular endothelial growth factors (anti-VEGFs). Further randomised controlled trials with increased numbers of participants would be of benefit to the evidence base, which would help lead to the formulation of future recommendations for the postoperative treatment cystoid macular oedema.

12.8. Postoperative eye shields

12.8.1. Review question

  • What is the effectiveness of postoperative eye shields to prevent complications after cataract extraction?

12.8.2. Introduction

The aim of this review was to determine the effectiveness of postoperative eye shields to prevent complications after cataract extraction. The review focussed on identifying studies that fulfilled the conditions specified in Table 57. For full details of the review protocol, see Appendix C.

Table 57. PICO inclusion criteria for the effectiveness of postoperative eye shields.

Table 57

PICO inclusion criteria for the effectiveness of postoperative eye shields.

Papers were excluded if they:

  • were narrative reviews, case studies/reports, commentaries, editorials/letters or opinion pieces
  • included animals, healthy eyes, other ocular conditions besides cataracts or mixed primary populations of people with different eye pathologies
  • were not published in the English language.

For flow charts of study inclusion and exclusion, see Appendix K. For the list of excluded studies with reasons, see Appendix F.

12.8.3. Evidence review

In total, 1,186 references were found from a database search for this review question, and full-text versions of 8 citations that seemed potentially relevant to this topic were retrieved. No studies matched the review protocol for this question.

No relevant studies were identified in the update searches undertaken at the end of the guideline development process.

12.8.4. Health economic evidence

A literature search was conducted jointly for all review questions in this guideline by applying standard health economic filters to a clinical search for cataracts (see Appendix D). A total of 4,306 references was retrieved, of which 0 were retained for this review question. Health economic modelling was not prioritised for this review question.

12.8.5. Evidence statements

No evidence was identified for this review question.

12.8.5.1. Health economic evidence

No health economic evidence was identified for this review question.

12.8.6. Evidence to recommendations

Relative value of different outcomesThe committee agreed that outcomes relating to either levels of accidental trauma or patient satisfaction would be relevant, but was not surprised that no relevant evidence was identified.
The committee agreed that there was currently a variation in practice between healthcare centres with some routinely giving patients postoperative eye shields and others not. They also noted that when eye shields are given, how long the patients wears them also differed, ranging from 2 days to 6 weeks postoperatively.
Trade-off between benefits and harmsThe committee agreed that the use of eye shields came down to individual preference and perception of protection postoperatively. They also noted that the patients may also become influenced by the experience of their partner or friends and family who have previously undergone cataract surgery.
The committee agreed that for the majority of people after surgery, there was unlikely to be a practical benefit from eye shields as modern surgical techniques mean the eye is at no greater risk of damage postoperatively than before surgery is undertaken. However, it noted that some people receive psychological reassurance from having an eye shield, and it may help them to return to their normal routine more quickly, as they are less concerned about potentially damaging their eye. As a result of these two opposing perspectives, the committee did not feel able to make either a positive or negative recommendation on the routine use of eye shields.
The committee agreed that it was important to make a specific recommendation for people who showed the residual effects of anaesthesia in the eye postoperatively, where there is potential for damage to the eye through accidental trauma. Therefore the committee agreed to recommend that postoperative eye protection be routinely offered to this subgroup.
Consideration of health benefits and resource useNo health economic evidence was identified for this review question and economic modelling was not prioritised. The committee noted that the cost of eye shields is very low (they are available for less than 50p) and therefore the economic impact of any recommendations made was likely to be minimal.
Quality of evidenceNo evidence was presented on which the committee could comment.
Other considerationsThe committee considered whether the lack of evidence indicated that a research recommendation was appropriate in this area. However, it agreed this did not represent a high priority for research and therefore no such recommendation was made.

12.8.7. Recommendations

51.

Offer eye protection for people whose eye shows residual effects of anaesthesia at the time of discharge after cataract surgery.

Copyright © NICE 2017.
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