Economic evaluation of prevention of cystoid macular edema after cataract surgery in diabetic patients: ESCRS PREMED study report 6.

PURPOSE: To investigate the cost-effectiveness of prophylactic treatments against cystoid macular edema after cataract surgery in diabetic patients. SETTING: 7 ophthalmology clinics in the Netherlands and Belgium. DESIGN: Prospective trial-based cost-effectiveness analysis using data from a European multicenter randomized clinical trial. METHODS: Diabetic patients (n = 163) undergoing uneventful cataract surgery were randomized to perioperative subconjunctival triamcinolone acetonide (n = 36), perioperative intravitreal bevacizumab (n = 36), combination treatment (n = 45), or no additional treatment (control group, n = 46). The cost analysis was performed from a healthcare perspective within a 12-week postoperative time horizon. The main effectiveness outcome was quality-adjusted life years (QALYs). The main cost-effectiveness outcome was the incremental cost-effectiveness ratio (ICER; cost per QALY). RESULTS: The mean total healthcare costs and QALYs were as follows: triamcinolone group €1827 (U.S. dollars [$] 2295)/0.166; bevacizumab group €2050 ($2575)/0.144; combination group €2027 ($2546)/0.166; and control group €2041 ($2564)/0.156. Bevacizumab and control treatment were most costly and least effective. The ICER was €321 984 ($404 503) per QALY for the combination group compared with that of the triamcinolone group. Assuming the willingness-to-pay as €20 000 ($25 126) per QALY, the cost-effectiveness probability was 70% and 23% in the triamcinolone and combination groups, respectively. No patient who received triamcinolone developed clinically significant macular edema (CSME). A secondary cost-effectiveness analysis based on this outcome showed a clear preference for triamcinolone. CONCLUSIONS: In diabetic patients, subconjunctival triamcinolone was effective in preventing CSME after cataract surgery. The cost-effectiveness analysis showed that triamcinolone is also cost-effective.

Economic evaluation of prevention of cystoid macular edema after cataract surgery in patients without diabetes: ESCRS PREMED study report 4.

PURPOSE: To investigate the cost-effectiveness of prophylactic treatments against cystoid macular edema (CME) after cataract surgery in patients without diabetes. SETTING: Seven ophthalmology clinics in the Netherlands and Belgium. DESIGN: Prospective cost-effectiveness analysis using data from a European multicenter randomized clinical trial (ESCRS PREMED). METHODS: Patients without diabetes planned for expected uneventful cataract surgery were randomized to topical bromfenac (Yellox, n = 242), topical dexamethasone (n = 242), or a combination treatment (n = 238). All relevant resources from a healthcare perspective were included in the cost analysis within a time horizon of 12 weeks postoperatively. The main effectiveness outcome was quality-adjusted life years (QALYs). The main cost-effectiveness outcome was the incremental cost-effectiveness ratio (ICER) based on the cost per QALY. RESULTS: The study comprised 722 patients without diabetes. Total healthcare costs and QALYs were € 447 (US $562) and 0.174 in the bromfenac group, €421 (US $529) and 0.179 in the dexamethasone group, and €442 (US $565) and 0.182 in the combination group. Bromfenac was most costly and least effective (ie, strongly dominated). The ICER was €6544 (US $8221) per QALY for the combination group compared with the dexamethasone group. Assuming that the willingness to pay is € 20 000 (US $25 126) per QALY, the cost-effectiveness probability was 3%, 32%, and 65% in the bromfenac, dexamethasone, and combination groups, respectively. CONCLUSIONS: In patients without diabetes, combination treatment with topical bromfenac and dexamethasone was effective and cost-effective in preventing CME after cataract surgery compared with treatment with either drug alone.

Randomized controlled European multicenter trial on the prevention of cystoid macular edema after cataract surgery in diabetics: ESCRS PREMED Study Report 2.

PURPOSE: To compare the efficacy of perioperative treatment strategies, in addition to topical bromfenac 0.09% and dexamethasone 0.1%, to reduce the risk for developing cystoid macular edema (CME) after uneventful cataract surgery in diabetic patients. SETTING: Twelve European study centers. DESIGN: Randomized clinical trial. METHODS: Diabetic patients having phacoemulsification cataract surgery were randomly allocated to receive no additional treatment, a subconjunctival injection with 40 mg triamcinolone acetonide, an intravitreal injection with 1.25 mg bevacizumab, or a combination of both. The main outcomes were the difference in central subfield mean macular thickness, corrected distance visual acuity, and the incidence of CME and clinically significant macular edema within 6 and 12 weeks postoperatively. RESULTS: The study comprised 213 patients. At 6 and 12 weeks postoperatively, the central subfield mean macular thickness was 12.3 µm and 9.7 µm lower, respectively, in patients who received subconjunctival triamcinolone acetonide than patients who did not (P = .007 and P = .014, respectively). No patient who received subconjunctival triamcinolone acetonide developed CME. Intravitreal bevacizumab had no significant effect on macular thickness. CONCLUSIONS: Diabetic patients who received a subconjunctival injection with triamcinolone acetonide at the end of cataract surgery had a lower macular thickness and macular volume at 6 and 12 weeks postoperatively than patients who did not. Intravitreal bevacizumab had no significant effect.

European multicenter trial of the prevention of cystoid macular edema after cataract surgery in nondiabetics: ESCRS PREMED study report 1.

PURPOSE: To compare the efficacy of a topical nonsteroidal antiinflammatory drug, topical corticosteroid, and a combination of both drugs to prevent the occurrence of cystoid macular edema (CME) after cataract surgery in nondiabetic patients. SETTING: Twelve European study centers. DESIGN: Randomized clinical trial. METHODS: Nondiabetic patients having uneventful cataract surgery were included in this study. Patients were randomized to receive topical bromfenac 0.09% twice daily for 2 weeks or dexamethasone 0.1% 4 times daily with 1 drop less per day every following week, or a combination of both. The primary outcome was the difference in central subfield mean macular thickness 6 weeks postoperatively. Secondary outcome measures included corrected distance visual acuity as well as the incidence of CME and clinically significant macular edema (CSME) within 6 weeks and 12 weeks postoperatively. RESULTS: This study comprised 914 patients. Six weeks postoperatively, the central subfield mean macular thickness was 288.3 µm, 296.0 µm, and 284.5 µm in the bromfenac group, dexamethasone group, and combination treatment group, respectively (overall P = .006). The incidence of clinically significant macular edema within 12 weeks postoperatively was 3.6%, 5.1%, and 1.5%, respectively (overall P = .043). CONCLUSION: Patients treated with a combination of topical bromfenac 0.09% and dexamethasone 0.1% had a lower risk for developing CSME after cataract surgery than patients treated with a single drug.

Prevention of macular edema after cataract surgery.

PURPOSE OF REVIEW: Although cataract surgery can effectively restore visual function in many patients with cataract, PCME remains an important cause of suboptimal visual acuity. The present review provides an overview of the current literature on the prevention and treatment of PCME. RECENT FINDINGS: Optimal prevention of PCME starts preoperatively with a personalized risk assessment. Diabetes mellitus, retinal vein occlusion, epiretinal membrane, macular hole, and uveitis are the most important risk factors for developing cystoid macular edema after cataract surgery. Topical NSAIDs either in addition to, or instead of, topical corticosteroids reduce the risk of developing PCME. Additional intravitreal corticosteroid and antivascular endothelial growth factor injections have been studied in patients with diabetes. Timely diagnosis and treatment of PCME is essential. Topical NSAIDs solely, or in addition to corticosteroids, improve visual acuity in patients with PCME. Oral acetazolamide and intravitreal dexamethasone implants have been used in refractory cases. SUMMARY: Topical NSAIDs can be used solely, or in combination with topical corticosteroids, to prevent and treat PCME. Further research is needed to compare the efficacy of various NSAIDs, and to investigate the cost-effectiveness and long-term benefit of anti-inflammatory treatments on visual acuity, contrast sensitivity, and quality of life.

Treatment of cystoid macular edema after cataract surgery.

The purpose of this review was to determine the optimum pharmacologic treatment for cystoid macular edema (CME) after cataract surgery in nondiabetic and diabetic patients. The Cochrane Library, Medline, and Embase databases were searched, and all randomized controlled trials (RCTs) that compared at least 2 pharmacologic strategies for CME after cataract surgery were included. Studies were excluded if preoperative CME or other risk factors for developing CME postoperatively were present. Ten RCTs were included in the systematic review. Five trials included at least 30 participants. Three RCTs showed a greater visual acuity improvement in patients treated with topical nonsteroidal antiinflammatory drugs (NSAIDs) than with a placebo. Other studies comparing the efficacy of topical NSAIDs, topical corticosteroids, sub-Tenon corticosteroids, oral NSAIDs, and oral acetazolamide did not report significant differences between treatment groups. Therefore, large RCTs are needed to provide evidence-based recommendations for the optimum treatment of CME after cataract surgery.

Phakic intraocular lens: Two-year results and comparison of endothelial cell loss with iris-fixated intraocular lenses.

PURPOSE: To evaluate the efficacy, safety, and stability of a foldable angle-supported Acrysof Cachet phakic intraocular lens (pIOL) to correct moderate to high myopia and compare endothelial cell loss after iris-fixated Artisan and Artiflex pIOL implantation. SETTING: University Eye Clinic Maastricht, the Netherlands. DESIGN: Retrospective observational study. METHODS: Foldable angle-supported pIOL implantation for myopia ranging from -6.0 to -16.5 diopters (D) was done. Uncorrected (UDVA) and corrected (CDVA) distance visual acuity, spherical equivalent (SE), and adverse events were documented preoperatively and 6 months and 1 and 2 years postoperatively. Endothelial cell loss after implantation of the foldable angle-supported pIOL and iris-fixated pIOLs was compared 6 months and 1 and 2 years postoperatively. RESULTS: There were 158 eyes. The UDVA was equal to or more than 20/25 in 95% of eyes at 1 and 2 years postoperatively. The mean SE was -0.17 D ± 0.43 (SD) 2 years postoperatively. One patient developed pupil ovalization, resulting in explantation of the pIOL from both eyes. Acute endothelial cell loss in the foldable angle-supported pIOL group was -3.2% ± 0.7%, significantly higher than after iris-fixated pIOL implantation. Chronic endothelial cell loss from 6 to 24 months after surgery was -3.8% ± 0.7%. At the 2-year follow-up, the chronic endothelial cell loss in the foldable angle-supported pIOL group was not different than with iris-fixated pIOLs (P > .05). CONCLUSIONS: The foldable angle-supported pIOL effectively corrected moderate to high myopia. However, acute surgical endothelial cell loss was significantly higher than with iris-fixated pIOLs. FINANCIAL DISCLOSURE: Dr. Nuijts is a consultant to Alcon Laboratories, Inc., Théa Pharma GmbH, and ASICO LLC; he has received study grants from Acufocus, Inc., Alcon Laboratories, Inc., Carl Zeiss Meditec AG, Ophtec BV, and Physiol S.A. No other author has a financial or proprietary interest in any material or method mentioned.

Prevention of Cystoid Macular Edema After Cataract Surgery in Nondiabetic and Diabetic Patients: A Systematic Review and Meta-Analysis.

PURPOSE: To evaluate the optimum medical strategy to prevent cystoid macular edema (CME) after cataract surgery. DESIGN: Systematic review and meta-analysis. METHODS: setting: Cochrane, MEDLINE, and EMBASE databases were searched to identify eligible randomized controlled trials (RCTs). STUDY POPULATION: RCTs comparing medical strategies to prevent CME after uncomplicated cataract surgery in nondiabetic and diabetic patients. OBSERVATION PROCEDURES: Data were extracted by 2 authors independently. Quality of individual RCTs was assessed using the Cochrane Collaboration's tool for assessing risk of bias and Delphi criteria. MAIN OUTCOME MEASURES: Odds of developing CME within 3 months postoperatively and foveal thickness, macular volume and corrected distance visual acuity change within 3 months postoperatively, as compared to baseline. RESULTS: Seventeen trials reported incidence rates. Topical nonsteroidal anti-inflammatory drugs (NSAIDs) significantly reduced the odds of developing CME as compared to topical corticosteroids in nondiabetic (odds ratio [OR] 0.11; 95% confidence interval [95% CI] 0.03-0.37) and mixed populations (OR 0.05; 95% CI 0.02-0.11). A combination of topical corticosteroids and NSAIDs significantly reduced the odds of developing CME as compared to topical corticosteroids in nondiabetic (OR 0.21; 95% CI 0.10-0.44) and diabetic patients (OR 0.17; 95% CI 0.05-0.50). Intravitreal corticosteroid or anti-vascular endothelial growth factor injections did not show any additional benefit in diabetic subjects. CONCLUSIONS: Topical NSAIDs significantly reduced the odds of developing CME, as compared to topical corticosteroids, in nondiabetic and mixed populations. A combination of topical NSAIDs and corticosteroids reduced the odds of developing CME in nondiabetic and diabetic patients, as compared to topical corticosteroids.

The ketogenic diet as a treatment option in adults with chronic refractory epilepsy: efficacy and tolerability in clinical practice.

The ketogenic diet (KD) is a high-fat, low-protein, low-carbohydrate diet that is used as a treatment for patients with difficult-to-control epilepsy. The present study assesses the efficacy and tolerability of the KD as an add-on therapy in adults with chronic refractory epilepsy. 15 adults were treated with the classical diet or MCT diet. During a follow-up period of 1 year we assessed seizure frequency, seizure severity, tolerability, cognitive performance, mood and quality of life (QOL). We found a significant reduction in seizures among the patients who followed the diet at least 1 year (n=5). Of these 5 patients, 2 had a reduction between 50 and 90%. Analyzing the study months separately, we found a seizure reduction of ≥50% in 26.6% of the patients during at least 1 month of treatment. Common side-effects were gastrointestinal disorders, loss of weight and fatigue. There was a considerable, non-significant improvement found in mood and QOL scores. Improvements were independent of reduction in seizure frequency, indicating that the effects of the KD reach further than seizure control.