Evidence-based Danish guidelines for screening of diabetic retinopathy.

PURPOSE: Diabetic retinopathy (DR) is among the leading causes of visual loss in the working-age population. It is generally accepted that screening of DR is cost-effective and can detect DR before it becomes sight-threatening to allow timely treatment. METHODS: A group of retinal specialists was formed by the Danish Ophthalmological Society with the aim to formulate contemporary evidence-based guidelines for screening of DR in order to implement these in the Danish screening system. RESULTS: We hereby present evidence for DR-screening regarding (1) classification of DR, (2) examination techniques, (3) screening intervals and (4) automated screening. It is our recommendation that the International Clinical Retinopathy Disease Severity Scale should be used to classify DR. As a minimum, mydriatic two-field disc- and macular-centred images are required. In the case of suspected clinically significant diabetic macular oedema, supplementary optical coherence tomography can increase the diagnostic accuracy. There is solid evidence to support a flexible, individualized screening regimen. In particular, it is possible to prolong screening intervals to 24-48 months for patients with no or mild nonproliferative diabetic retinopathy (NPDR), but it is also possible to use extended intervals of 12-24 months for patients with moderate NPDR given that these are well-regulated regarding glycaemic control (HbA1c ≤ 53 mmol/mol) and blood pressure (≤130/80 mmHg). Automated screening of DR is encouraging but is not ready for implementation at present. CONCLUSION: Danish evidenced-based guidelines for screening of DR support high-quality imaging and allow flexible, individualized screening intervals with a potential for extension to patients with low risk of DR progression.

Do evidence-based guidelines change clinical practice patterns?

In 2013, the Danish Health and Medicines Authorities published a National Clinical Guideline on the treatment of age-related cataracts. The guideline provided evidence-based recommendations on the indication for cataract surgery, cataract surgery in patients with age-related macular degeneration, on the use of toric intraocular lenses (IOLs) to correct preoperative corneal astigmatism, the use of intracameral and topical antibiotics to prevent endophthalmitis, choice of anti-inflammatory medication to control postoperative inflammation and prevent cystoid macular oedema, the use of immediate sequential bilateral cataract surgery and on the postoperative check-up of patients. A questionnaire was sent to all members of the Danish Ophthalmological Society before and after publication of the guideline. The responses showed that the guideline had changed practice patterns so that surgeons were more likely to prescribe non-steroidal anti-inflammatory eye drops and to not prescribe topical antibiotic eye drops after the guideline was published. Other parameters, most notably the use of toric IOLs and use of postoperative examinations were more guided by reimbursement standards than by evidence-based medicine. Thus, evidence-based guidelines do change practice patterns unless they are counteracted by the reimbursement system.

Toric Intraocular Lenses in the Correction of Astigmatism During Cataract Surgery: A Systematic Review and Meta-analysis.

TOPIC: We performed a systematic review and meta-analysis to evaluate the benefit and harms associated with implantation of toric intraocular lenses (IOLs) during cataract surgery. Outcomes were postoperative uncorrected distance visual acuity (UCDVA) and distance spectacle independence. Harms were evaluated as surgical complications and residual astigmatism. CLINICAL RELEVANCE: Postoperative astigmatism is an important cause of suboptimal UCDVA and need for distance spectacles. Toric IOLs may correct for preexisting corneal astigmatism at the time of surgery. METHODS: We performed a systematic literature search in the Embase, PubMed, and CENTRAL databases within the Cochrane Library. We included randomized clinical trials (RCTs) if they compared toric with non-toric IOL implantation (± relaxing incision) in patients with regular corneal astigmatism and age-related cataracts. We assessed the risk of bias using the Cochrane Risk of Bias tool. We assessed the quality of evidence across studies using the GRADE profiler software (available at: www.gradeworkinggroup.org). RESULTS: We included 13 RCTs with 707 eyes randomized to toric IOLs and 706 eyes randomized to non-toric IOLs; 225 eyes had a relaxing incision. We found high-quality evidence that UCDVA was better in the toric IOL group (logarithm of the minimum angle of resolution [logMAR] mean difference, -0.07; 95% confidence interval [CI], -0.10 to -0.04) and provided greater spectacle independence (risk ratio [RR], 0.51; 95% CI, 0.36-0.71) and moderate quality evidence that toric IOL implantation was not associated with an increased risk of complications (RR, 1.73; 95% CI, 0.60-5.04). Residual astigmatism was lower in the toric IOL group than in the non-toric IOL plus relaxing incision group (mean difference, 0.37 diopter [D]; 95% CI, -0.55 to -0.19). CONCLUSIONS: We found that toric IOLs provided better UCDVA, greater spectacle independence, and lower amounts of residual astigmatism than non-toric IOLs even when relaxing incisions were used.

Indication for cataract surgery. Do we have evidence of who will benefit from surgery? A systematic review and meta-analysis.

The need for cataract surgery is expected to rise dramatically in the future due to the increasing proportion of elderly citizens and increasing demands for optimum visual function. The aim of this study was to provide an evidence-based recommendation for the indication of cataract surgery based on which group of patients are most likely to benefit from surgery. A systematic literature search was performed in the MEDLINE, CINAHL, EMBASE and COCHRANE LIBRARY databases. Studies evaluating the outcome after cataract surgery according to preoperative visual acuity and visual complaints were included in a meta-analysis. We identified eight observational studies comparing outcome after cataract surgery in patients with poor (<20/40) and fair (>20/40) preoperative visual acuity. We could not find any studies that compared outcome after cataract surgery in patients with few or many preoperative visual complaints. A meta-analysis showed that the outcome of cataract surgery, evaluated as objective and subjective visual improvement, was independent on preoperative visual acuity. There is a lack of scientific evidence to guide the clinician in deciding which patients are most likely to benefit from surgery. To overcome this shortage of evidence, many systems have been developed internationally to prioritize patients on waiting lists for cataract surgery, but the Swedish NIKE (Nationell Indikationsmodell för Katarakt Ekstraktion) is the only system where an association to the preoperative scoring of a patient has been related to outcome of cataract surgery. We advise that clinicians are inspired by the NIKE system when they decide which patients to operate to ensure that surgery is only offered to patients who are expected to benefit from cataract surgery.

Immediate Sequential Bilateral Cataract Surgery: A Systematic Review and Meta-Analysis.

The aim of the present systematic review was to examine the benefits and harms associated with immediate sequential bilateral cataract surgery (ISBCS) with specific emphasis on the rate of complications, postoperative anisometropia, and subjective visual function in order to formulate evidence-based national Danish guidelines for cataract surgery. A systematic literature review in PubMed, Embase, and Cochrane central databases identified three randomized controlled trials that compared outcome in patients randomized to ISBCS or bilateral cataract surgery on two different dates. Meta-analyses were performed using the Cochrane Review Manager software. The quality of the evidence was assessed using the GRADE method (Grading of Recommendation, Assessment, Development, and Evaluation). We did not find any difference in the risk of complications or visual outcome in patients randomized to ISBCS or surgery on two different dates. The quality of evidence was rated as low to very low. None of the studies reported the prevalence of postoperative anisometropia. In conclusion, we cannot provide evidence-based recommendations on the use of ISBCS due to the lack of high quality evidence. Therefore, the decision to perform ISBCS should be taken after careful discussion between the surgeon and the patient.

Antibiotic prevention of postcataract endophthalmitis: a systematic review and meta-analysis.

Endophthalmitis is one of the most feared complications after cataract surgery. The aim of this systematic review was to evaluate the effect of intracameral and topical antibiotics on the prevention of endophthalmitis after cataract surgery. A systematic literature review in the MEDLINE, CINAHL, Cochrane Library and EMBASE databases revealed one randomized trial and 17 observational studies concerning the prophylactic effect of intracameral antibiotic administration on the rate of endophthalmitis after cataract surgery. The effect of topical antibiotics on endophthalmitis rate was reported by one randomized trial and one observational study. The quality and design of the included studies were analysed using the Cochrane risk of bias tool. The quality of the evidence was evaluated using the GRADE approach. We found high-to-moderate quality evidence for a marked reduction in the risk of endophthalmitis with the use of intracameral antibiotic administration of cefazolin, cefuroxime and moxifloxacin, whereas no effect was found with the use of topical antibiotics or intracameral vancomycin. Endophthalmitis occurred on average in one of 2855 surgeries when intracameral antibiotics were used compared to one of 485 surgeries when intracameral antibiotics were not used. The relative risk (95% CI) of endophthalmitis was reduced to 0.12 (0.08; 0.18) when intracameral antibiotics were used. The difference was highly significant (p < 0.00001). Intracameral antibiotic therapy is the best choice for preventing endophthalmitis after cataract surgery. We did not find evidence to conclude that topical antibiotic therapy prevents endophthalmitis.

Cataract surgery and age-related macular degeneration. An evidence-based update.

PURPOSE: Age-related macular degeneration (AMD) and cataract often coexist in patients and concerns that cataract surgery is associated with an increased risk of incidence or progression of existing AMD has been raised. This systematic review and meta-analysis is focused on presenting the evidence concerning progression of AMD in patients undergoing cataract surgery. METHODS: We performed a systematic literature search in the PubMed, Medline, Cochrane Library and CINAHL databases. Two randomized trials and two case-control trials were identified. Quality of the studies was assessed using the Cochrane risk of bias tool, data were extracted, and meta-analyses were performed. Quality of the available evidence was evaluated using the GRADE system. RESULTS: We found that visual acuity at 6-12 months follow-up was significantly better (6.5-7.5 letters) in eyes that had undergone cataract surgery than in unoperated eyes, but the included number of subjects was small, and hence, the quality of evidence was downgraded to moderate. We did not find an increased risk of progression to exudative AMD 6-12 months after cataract surgery [RR 3.21 (0.14-75.68)], but the included number of subjects was small, and thus, the quality of the evidence was moderate. CONCLUSION: Cataract surgery increases visual acuity without an increased risk of progression to exudative AMD, but further research with longer follow-up is encouraged.

Safety of deferring review after uneventful cataract surgery until 2 weeks postoperatively.

UNLABELLED: We conducted a systematic review and metaanalysis to provide evidence-based recommendations on the value of early postoperative review. We identified 3 randomized controlled trials (RCTs) that compared patients seen on the first postoperative day with those reviewed at 2 weeks; the 3 studies comprised 886 patients. The risk for postoperative complications was lower when review was deferred 2 weeks because of early transient pressure spikes. There was no difference in the number of unscheduled visits during the first 2 weeks postoperatively or the visual acuity at follow-up. No safety was gained by reviewing patients on the first postoperative day, and we recommend that routine early postoperative control can be omitted in nonglaucomatous patients after uneventful surgery if symptomatic patients are seen by an ophthalmologist as needed. FINANCIAL DISCLOSURE: No author has a financial or proprietary interest in any material or method mentioned.

Post-cataract prevention of inflammation and macular edema by steroid and nonsteroidal anti-inflammatory eye drops: a systematic review.

PURPOSE: Favorable outcome after cataract surgery depends on proper control of the inflammatory response induced by cataract surgery. Pseudophakic cystoid macular edema is an important cause of visual decline after uncomplicated cataract surgery. DESIGN: We compared the efficacy of topical steroids with topical nonsteroidal anti-inflammatory drugs (NSAIDs) in controlling inflammation and preventing pseudophakic cystoid macular edema (PCME) after uncomplicated cataract surgery. PARTICIPANTS: Patients undergoing uncomplicated surgery for age-related cataract. METHODS: We performed a systematic literature search in Medline, CINAHL, Cochrane, and EMBASE databases to identify randomized trials published from 1996 onward comparing topical steroids with topical NSAIDs in controlling inflammation and preventing PCME in patients undergoing phacoemulsification with posterior chamber intraocular lens implantation for age-related cataract. MAIN OUTCOME MEASURES: Postoperative inflammation and pseudophakic cystoid macular edema. RESULTS: Fifteen randomized trials were identified. Postoperative inflammation was less in patients randomized to NSAIDs. The prevalence of PCME was significantly higher in the steroid group than in the NSAID group: 3.8% versus 25.3% of patients, risk ratio 5.35 (95% confidence interval, 2.94-9.76). There was no statistically significant difference in the number of adverse events in the 2 treatment groups. CONCLUSIONS: We found low to moderate quality of evidence that topical NSAIDs are more effective in controlling postoperative inflammation after cataract surgery. We found high-quality evidence that topical NSAIDs are more effective than topical steroids in preventing PCME. The use of topical NSAIDs was not associated with an increased events. We recommend using topical NSAIDs to prevent inflammation and PCME after routine cataract surgery.

The filtering, clear-cornea diathermal keratostomy: a minor Danish multicenter study.

PURPOSE: Is the new micropenetrating, clear-cornea procedure, intrastromal diathermal keratostomy (IDK), an alternative to the intricate "modern trabeculectomy"? METHODS: Prospective multicenter study. Four surgeons from 4 Danish eye departments attended an IDK course and subsequently decided when to start their consecutive IDK series. The data were analyzed centrally. Injection of preoperative, subconjunctival doses of mitomycin C (MMC) was recommended according to risk-of-failure. A total of 54 eyes from 48 patients with advanced and complicated glaucomas (mean age 65 y) and preoperative mean intraocular pressure (IOP) of 29 mm Hg were studied. RESULTS: At 10 months (range: 3 to 34 mo) the total success rate, employing traditional IOP success criteria (IOP< or =18 mm Hg and postoperative IOP decrease > or =30%), was 87% (47 of 54 eyes). In the 69% (37 of 54 eyes) without medication, the final IOP+/-SD was 11+/-3.5 mm Hg. Employing new IOP success criteria (IOP< or =15 mm Hg and postoperative IOP decrease> or =30%) for severe glaucoma (cup/disc ratio> or =0.8) and traditional criteria for moderate glaucoma (cup/disc ratio< or =0.7) the success rates were 76% and 80% and the mean postoperative IOP+/-SD were 10+/-2.5 mm Hg and 13+/-2.5 mm Hg, respectively. No serious complications (malignant glaucoma, endophthalmitis) were seen. The success rate for the most experienced and the less experienced surgeons, with risk-of-failure factors per eye of 1.3 and 1.2, was similar at 88% and 86%, respectively. The "knife time" for the experienced surgeon averaged 15 minutes (range: 10 to 20 min). The success rate (traditional criteria) after IDK revision with internal needling was 69%. CONCLUSIONS: MMC IDK seems to be simpler and quicker than the modern trabeculectomy, and with similar success rate and safety. Revision by internal needling is easy and efficient. Thus, MMC IDK may be a valid alternative and may also be recommended after failed MMC trabeculectomy, replacing shunting. Randomized, controlled studies are indicated.

Determinants of bleb morphology in minimally invasive, clear-cornea micropenetrating glaucoma surgery with mitomycin C.

PURPOSE: Antimetabolites, especially mitomycin C (MMC), increase the incidence of late bleb-related endophthalmitis in trabeculectomy. This is related to a higher incidence of avascular, thin, cystic, translucent blebs, which may be caused by a toxic effect on conjunctival tissue. An MMC dose-response study was carried out focusing on bleb morphology and function. PATIENTS AND METHODS: In a retrospective, comparative case series study, 2 successive groups of patients with complicated glaucoma were compared 2 years after a special, minimally invasive, filtering procedure (intrastromal holmium laser keratostomy). Preoperative local subconjunctival injections of a fixed MMC dose (4 microg) were used in group A, and lower MMC doses, calculated individually (1 or 2 microg), were used in group B. Bleb vascularity and morphology were evaluated by masked grading of photomicrographs. Bleb function was evaluated by intraocular pressure (IOP). RESULTS: Total bleb avascularity occurred in 63% of the blebs in group A and 0% in group B (P < 0.01). In eyes with IOP < or = 20 mmHg without medical treatment, the mean IOP was significantly lower in group 1 (8 vs 15 mm Hg, P < 0.002). A translucent cystic bleb without conjunctival stroma was observed in only 1 eye in group A. An optimal spongy stromal bleb was observed in all other eyes (96%) despite the different MMC doses. The numbers of complications in the 2 groups were nearly equal. CONCLUSIONS: Bleb avascularity after 4 microg MMC could be avoided by the use of 1 or 2 microg MMC on the basis of preoperative prognosticators for failure, but at the expense of some of the IOP-lowering effect. This indicates that the therapeutic index (clinical safety margin) of MMC seems to be narrow. An MMC dose-response relation was not observed for the thin, cystic, and translucent bleb. The low incidence of this bleb (4%) indicates that the operative technique, apart from the vascularity, may be the most essential determinant of bleb morphology.

Cataract surgery on diabetic patients. A prospective evaluation of risk factors and complications.

PURPOSE: This study presents an evaluation of cataract surgery on diabetic patients. One experienced surgeon carried out phaco emulsification on all subjects and the same surface-coated one-piece PMMA-lens-type was implanted. The lens fluorescence and the blood-aqueous barrier (BAB) were then evaluated as experimental preoperative risk indicators. RESULTS: During follow-up, 10 out of 39 diabetic patients progressed unilaterally in diabetic retinopathy or developed macular oedema, a significant relative risk. Neither lens fluorescence, BAB, HbA1c, level of retinopathy, type/duration of diabetes, diabetes treatment or antihypertensive treatment differed significantly between the group of patients with postoperative progression of retinopathy/macular oedema and those without. Results indicated NIDDM (non-insulin-dependent diabetes mellitus/type 2 diabetes) patients might have increased risk of a postoperative macular oedema. CONCLUSION: When diabetic retinopathy (DR) is not in a proliferative phase it should not be regarded as a contraindication to modern cataract surgery. Neither lens fluorescence nor BAB is valuable as a risk indicator for postoperative progression of DR.