Longer-Term Anti-VEGF Therapy Outcomes in Neovascular Age-Related Macular Degeneration, Diabetic Macular Edema, and Vein Occlusion-Related Macular Edema: Clinical Outcomes in 130 247 Eyes.

PURPOSE: The clinical practice visual acuity (VA) outcomes of anti-VEGF therapy for up to 5 years were assessed in patients with neovascular age-related macular degeneration (nAMD), diabetic macular edema (DME), branch retinal vein occlusion-related macular edema (BRVO-ME), and central retinal vein occlusion-related macular edema (CRVO-ME). DESIGN: A retrospective analysis was performed using the Vestrum Health Retina Database. PARTICIPANTS: Treatment-naive patients with nAMD, DME, BRVO-ME, or CRVO-ME who received anti-VEGF injections between 2014 and 2019 and had follow-up data for ≥12 months. METHODS: Data on age, sex, the number of anti-VEGF treatments, and VA were analyzed. MAIN OUTCOME MEASURES: Mean VA change up to 3 years (BRVO-ME and CRVO-ME) and 5 years (nAMD and DME). RESULTS: At 1, 3, and 5 years, in 67 666, 21 305, and 5208 eyes with nAMD, after a mean of 7.6, 19.5, and 32 injections, there was a mean change of +3.1, -0.2, and -2.2 letters, respectively. At 1, 3, and 5 years, in 40 832, 7728, and 1192 eyes with DME, after a mean of 6.2, 15.4, and 26.0 injections, there was a mean change of +4.7, +3.3, and +3.1 letters, respectively. At 1 and 3 years, in 12 451 and 3027 eyes with BRVO-ME, after a mean of 7.1 and 18.2 injections, there was a mean change of +9.5 and +7.7 letters, respectively. At 1 and 3 years, in 9298 and 2264 eyes with CRVO-ME, after a mean of 7.3 and 18.8 injections, there was a mean change of +8.3 and +6.0 letters, respectively (P < 0.01 for all VA changes of > 1 letter). In all 4 conditions, the mean VA increased with the mean number of anti-VEGF injections, eyes with a baseline VA of 20/40 or better tended to lose VA, and eyes with progressively worse baseline VA experienced a progressively greater VA gain at 3 years. CONCLUSIONS: In practice, patients with nAMD, DME, BRVO-ME, and CRVO-ME showed limited visual outcomes, with patients with nAMD tending to lose VA at 3 and 5 years. Across all 4 disorders, the mean change in VA correlated with treatment intensity at 1, 3, and 5 years. Patients with better baseline VA are more vulnerable to vision loss.

Visual acuity outcomes and anti-VEGF therapy intensity in diabetic macular oedema: a real-world analysis of 28 658 patient eyes.

BACKGROUND/AIM: To assess visual acuity (VA) outcomes and antivascular endothelial growth factor (anti-VEGF) treatment intensity in diabetic macular oedema (DMO). METHODS: Retrospective analysis was performed in treatment-naïve patients with DMO from 2013 to 2018 using a database of aggregated de-identified electronic medical records (Vestrum Health). RESULTS: At 1 year, 28 658 patient eyes underwent a mean of 6.4 anti-VEGF injections, gaining a mean of +4.2 letters (95% confidence interval for mean gain: +4.0 to +4.5 letters, p<0.001). When stratified by anti-VEGF medication and by years 2013-2018, no clinically meaningful differences in injection frequency or 1-year VA change resulted. At 1 year, 50% of eyes received ≤6 injections, while <20% received 10-13 injections, representing monthly treatment. Mean letters gained at 1 year generally showed a linear relationship with mean number of anti-VEGF injections, beyond two injections. Eyes with good baseline VA (≥20/40) generally were at risk of VA loss at 1 year; those with moderately severe baseline impairment (20/70 to 20/200) who received ≥10 injections improved by a mean of +10.3 letters. CONCLUSION: In clinical practice, patients with DMO undergo fewer anti-VEGF injections and exhibit worse visual gains compared with patients in randomised clinical trials. Visual outcomes correlate with treatment intensity at 1 year, with ceiling effects related to baseline VA.

Development, Validation, and Innovation in Ophthalmic Laser-Based Imaging: Report From a US Food and Drug Administration-Cosponsored Forum.

In April 2019, the US Food and Drug Administration, in conjunction with 11 professional ophthalmic, vision science, and optometric societies, convened a forum on laser-based imaging. The forum brought together the Food and Drug Administration, clinicians, researchers, industry members, and other stakeholders to stimulate innovation and ensure that patients in the US are the first in the world to have access to high-quality, safe, and effective medical devices. This conference focused on the technology, clinical applications, regulatory issues, and reimbursement issues surrounding innovative ocular imaging modalities. Furthermore, the emerging role of artificial intelligence in ophthalmic imaging was reviewed. This article summarizes the presentations, discussion, and future directions.

Visual acuity outcomes and anti-VEGF therapy intensity in macular oedema due to retinal vein occlusion: a real-world analysis of 15 613 patient eyes.

BACKGROUND/AIMS: To assess visual acuity (VA) outcomes and antivascular endothelial growth factor (anti-VEGF) therapy intensity in retinal vein occlusion (RVO)-related macular oedema (ME). METHODS: A retrospective study was completed in treatment-naïve patients with RVO-related ME from 2013 to 2019, using the Vestrum Health Retina Database. RESULTS: Mean baseline age was 72.4 years and 54% were women. In 6 months, in 8876 eyes with branch retinal vein occlusion (BRVO)-related ME, after a mean of 4.5 anti-VEGF injections, VA increased by 9.4 letters (95% confidence interval (CI) for change in VA +8.94 to +9.78, p<0.001) from a baseline of 55.1 letters. In 6737 eyes with central retinal vein occlusion (CRVO)-related ME, after a mean of 4.6 anti-VEGF injections over 6 months, VA improved by 9.2 letters (95% CI +8.50 to +9.87, p<0.001) from a baseline of 37.2 letters. In 1 year, VA gain was similar (BRVO: 7.4 injections, +8.1 letters, 95% CI +7.55 to +8.57, p<0.001; CRVO: 7.6 injections, +7.1 letters, 95% CI +6.31 to +7.95, p<0.001). In 6 months and 1 year, mean letters gain increased with number of anti-VEGF injections. Patient eyes with baseline VA of 20/40 or better tended to lose VA in 1 year. CONCLUSION: Mean change in VA correlates with treatment intensity, but patients with better VA at presentation are susceptible to vision loss, reflecting a ceiling effect. Assessed with the same database, VA gains compare favourably with 1-year VA gains in neovascular age-related macular degeneration and diabetic ME, but exhibit a larger gap when compared with corresponding randomised controlled trials.

Baseline Visual Acuity at Wet AMD Diagnosis Predicts Long-Term Vision Outcomes: An Analysis of the IRIS Registry.

BACKGROUND AND OBJECTIVE: Clinical trials in neovascular age-related macular degeneration (nAMD) demonstrate that high visual acuity (VA) can be maintained, and low VA can be improved with anti-vascular endothelial growth factor (VEGF) treatment. Few real-world data investigating the relationship between baseline VA and long-term outcomes exist. This study compares VA at diagnosis and after treatment using data from a large patient registry. PATIENTS AND METHODS: Retrospective study of IRIS Registry patients diagnosed with nAMD in one or both eyes between January 2013 and June 2017. Patients received at least two anti-VEGF injections in the study eye(s) less than 45 days apart during the study period. Primary outcomes were the percentage of eyes with 20/40 VA or better at diagnosis and association of VA at diagnosis with longer-term visual outcomes. RESULTS: The study included 162,902 eyes. Among all included eyes, 34.3% presented with 20/40 VA or better at diagnosis. Patients with 20/40 vision or better at baseline maintained a mean VA of 20/40 or better for 2 years after treatment initiation. CONCLUSIONS: Baseline VA at nAMD diagnosis predicts long-term VA outcomes. Early diagnosis before VA is adversely affected is a key factor in preserving vision in patients with nAMD. [Ophthalmic Surg Lasers Imaging Retina. 2020;51:633-639.].

Visual Acuity Outcomes and Anti-Vascular Endothelial Growth Factor Therapy Intensity in Neovascular Age-Related Macular Degeneration Patients: A Real-World Analysis of 49 485 Eyes.

PURPOSE: This study assessed anti-vascular endothelial growth factor (VEGF) therapy intensity and its relationship with visual acuity (VA) change in real-world neovascular age-related macular degeneration (nAMD) patients. DESIGN: This retrospective analysis was performed on a large database of aggregated, longitudinal, de-identified electronic medical records from a geographically and demographically diverse sample of patients of United States retina specialists (Vestrum Health Retina Database). PARTICIPANTS: Treatment-naïve nAMD patients who underwent anti-VEGF injections between January 1, 2012, and October 31, 2016, were eligible if follow-up data were available before October 31, 2017. METHODS: Age, gender, anti-VEGF treatment type, number of treatments, and VA were extracted from the database. MAIN OUTCOME MEASURE: Mean VA change assessed at 1 year and stratified based on number of anti-VEGF injections received over 1 year. RESULTS: In this analysis, 49 485 eyes were included. The mean age was 80.9 years, and 64% were female. Mean baseline VA was 53.8 letters (Snellen equivalent, 20/80). At 1 year, after a mean of 7.3 anti-VEGF injections, there was a mean gain of 1 letter (0.95 letter; 95% confidence interval [CI] for change in VA, +0.77 to +1.13 letter; P < 0.001). When stratified by anti-VEGF agent, the mean VA changes were nearly identical at 1 year. There was a linear relationship between mean letters gained and mean number of injections, between 4 and 10 injections over 1 year, with 4 or fewer or 10 or more injections associated with loss of vision or a plateau, respectively. Greater mean 1-year change in VA also trended with worse baseline VA; those patients with better VA at presentation tended to be particularly vulnerable to vision loss. Those who received the fewest injections tended to be older and have worse baseline VA. CONCLUSIONS: Real-world nAMD patients receive fewer anti-VEGF injections and experience worse visual outcomes compared with patients receiving fixed, frequent therapy in randomized controlled trials. Mean change in VA correlates with treatment intensity at 1 year, but with ceiling effects related to treatment intensity and baseline VA. Older patients and those with poor baseline VA may be particularly prone to undertreatment.

Small gauge vitrectomy: operative techniques.

PURPOSE OF REVIEW: This article reviews operative techniques and risks associated with microincision vitrectomy surgery. RECENT FINDINGS: All three microincision vitrectomy surgery platforms (23, 25, and 27 gauge) are associated with both advantages and disadvantages, combined with similarly low rates of hypotony, endophthalmitis, corneal astigmatism, and postoperative inflammation. SUMMARY: Hybrid-gauge vitrectomy, utilizing larger gauge MIVS cannulas, preserves surgeon access to benefits of both larger and smaller gauge MIVS platforms without compromising safety, efficacy, or efficiency.

Comparison of Aflibercept, Bevacizumab, and Ranibizumab for Treatment of Diabetic Macular Edema: Extrapolation of Data to Clinical Practice.

IMPORTANCE: The Diabetic Retinopathy Clinical Research Network (DRCR Network), sponsored by the National Eye Institute, reported the results of a comparative effectiveness randomized clinical trial (RCT) evaluating the 3 anti-vascular endothelial growth factor (anti-VEGF) agents aflibercept (2.0 mg), bevacizumab (1.25 mg), and ranibizumab (0.3 mg) for treatment of diabetic macular edema (DME) involving the center of the retina and associated with visual acuity loss. The many important findings of the RCT prompted the American Society of Retina Specialists to convene a group of experts to provide their perspective regarding clinically relevant findings of the study. OBJECTIVES: To describe specific outcomes of the RCT judged worthy of highlighting, to discuss how these and other clinically relevant results should be considered by specialists treating DME, and to identify unanswered questions that merit consideration before treatment. EVIDENCE REVIEW: The DRCR Network-authored publication on primary outcomes of the comparative effectiveness RCT at 89 sites in the United States. The study period of the RCT was August 22, 2012, to August 28, 2013. FINDINGS: On average, all 3 anti-VEGF agents led to improved visual acuity in eyes with DME involving the center of the retina and with visual acuity impairment, including mean (SD) improvements by +13.3 (11.1) letters with aflibercept vs +9.7 (10.1) letters with bevacizumab (P < .001) and +11.2 (9.4) letters with ranibizumab (P = .03). Worse visual acuity when initiating therapy was associated with greater visual acuity benefit of aflibercept (+18.9 [11.5]) over bevacizumab (+11.8 [12.0]) or ranibizumab (14.2 [10.6]) 1 year later (P < .001 for interaction with visual acuity as a continuous variable, and P = .002 for interaction with visual acuity as a categorical variable). It is unknown whether different visual acuity outcomes associated with the use of the 3 anti-VEGF agents would be noted with other treatment regimens or with adequately repackaged bevacizumab, as well as in patients with criteria that excluded them from the RCT, such as persistent DME despite recent anti-VEGF treatment. CONCLUSIONS AND RELEVANCE: On average, all 3 anti-VEGF agents led to improved visual acuity in eyes with DME involving the center of the retina and visual acuity impairment. Worse visual acuity when initiating therapy was associated with greater visual acuity benefit of aflibercept over bevacizumab or ranibizumab 1 year later. Care needs to be taken when attempting to extrapolate outcomes of this RCT to differing treatment regimens. With access to adequately repackaged bevacizumab, many specialists might initiate therapy with bevacizumab when visual acuity is good (ie, 20/32 to 20/40 as measured in the DRCR Network), recognizing that the cost-effectiveness of bevacizumab outweighs that of aflibercept or ranibizumab.

Comparison of topical anesthetics for intravitreal injections : a randomized clinical trial.

PURPOSE: To determine whether there is a difference in anesthetic effect between topical proparacaine drops, 4% lidocaine solution, or 3.5% lidocaine gel, and whether this has an impact on the overall injection experience. METHODS: One hundred and twenty sequential patients undergoing intravitreal injections were randomized to 1 of 3 groups: proparacaine 0.5% drops (Group 1), proparacaine + 4% lidocaine-soaked cotton tipped swabs (Group 2), or 3.5% lidocaine gel (Group 3). Discomfort associated with the lid speculum, with the needle, and with burning sensation was graded on a scale of 0 to 10 (0 = no pain, 10 = worst pain ever). The overall injection experience was graded as Excellent, Very Good, Fair, Poor, or Awful. RESULTS: The average lid speculum pain score for Group 1 was 0.85, Group 2 was 0.50, and Group 3 was 0.65 (P = 0.32). The average needle pain score for Group 1 was 1.78, Group 2 was 1.75, and Group 3 was 1.48 (P = 0.38). The average burning pain score for Group 1 was 1.45, Group 2 was 1.58, and Group 3 was 1.13 (P = 0.23). Overall satisfaction was rated as Excellent or Very Good in 95%, 97.5%, and 92.5% of Group 1, 2, and 3 patients, respectively (P = 0.64). CONCLUSION: The use of topical proparacaine drops provides very effective and cost-effective anesthesia during office-based intravitreal injections.

Endophthalmitis in microincision vitrectomy: outcomes of gas-filled eyes.

PURPOSE: To assess whether performing an air or gas exchange at the conclusion of a microincision vitrectomy procedure is beneficial regarding the rate of endophthalmitis. METHODS: This was a collaborative, multicenter, retrospective chart review of 2,336 eyes that underwent microincision sutureless vitrectomy (23 or 25 gauge) with either SF6 or C3F8 gas endotamponade for macular hole between January 2008 and December 2009. For all eyes, the search methodology was structured to identify the main outcome measure, which was the occurrence of acute postoperative endophthalmitis (<6 weeks after pars plana vitrectomy). RESULTS: Of the cumulative 2,336 consecutive cases over a 2-year period, only 1 (0.04%) had postoperative endophthalmitis. All eyes had near-complete gas-fluid exchange at the end of surgery; C3F8 was the most common endotamponade agent. The majority of cases were performed with 23-gauge vitrectomy. No other complications were noted. CONCLUSION: Endophthalmitis was a rare occurrence in this large series of gas-filled eyes after macular hole surgery (0.04%). Gas endotamponade after microincision sutureless vitrectomy may be beneficial in reducing the risk of postoperative endophthalmitis; however, additional studies are necessary to make a definitive recommendation.

Two-year outcomes of the ranibizumab for edema of the mAcula in diabetes (READ-2) study.

OBJECTIVES: To determine the long-term effects of ranibizumab (RBZ) in patients with diabetic macular edema (DME). DESIGN: Prospective, randomized, interventional, multicenter clinical trial. PARTICIPANTS: One hundred twenty-six patients with DME. METHODS: Subjects were randomized 1:1:1 to receive 0.5 mg RBZ at baseline and months 1, 3, and 5 (group 1), focal or grid laser photocoagulation at baseline and month 3 if needed (group 2), or a combination of 0.5 mg RBZ and focal or grid laser at baseline and month 3 (group 3). Starting at month 6, if retreatment criteria were met, all subjects could be treated with RBZ. MAIN OUTCOME MEASURES: The mean change from baseline in best-corrected visual acuity (BCVA) at month 24. RESULTS: After the primary end point at month 6, most patients in all groups were treated only with RBZ, and the mean number of injections was 5.3, 4.4, and 2.9 during the 18-month follow-up period in groups 1, 2, and 3, respectively. For the 33 patients in group 1, 34 patients in group 2, and 34 patients in group 3 who remained in the study through 24 months, the mean improvement in BCVA was 7.4, 0.5, and 3.8 letters at the 6-month primary end point, compared with 7.7, 5.1, and 6.8 letters at month 24, and the percentage of patients who gained 3 lines or more of BCVA was 21, 0, and 6 at month 6, compared with 24, 18, and 26 at month 24. The percentage of patients with 20/40 or better Snellen equivalent at month 24 was 45% in group 1, 44% in group 2, and 35% in group 3. Mean foveal thickness (FTH), defined as center subfield thickness, at month 24 was 340 µm, 286 µm, and 258 µm for groups 1, 2, and 3, respectively, and the percentage of patients with center subfield thickness of 250 µm or less was 36%, 47%, and 68%, respectively. CONCLUSIONS: Intraocular injections of RBZ provided benefit for patients with DME for at least 2 years, and when combined with focal or grid laser treatments, the amount of residual edema was reduced, as were the frequency of injections needed to control edema. FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found after the references.

Short-term outcomes of 23-gauge pars plana vitrectomy.

PURPOSE: To report the initial experience and safety profile of 23-gauge pars plana vitrectomy (PPV) in eyes undergoing vitreoretinal surgery. DESIGN: Retrospective, multicenter, consecutive, interventional case series. METHODS: The inclusion criteria for this study included eyes that underwent primary, 23-gauge PPV for various indications including, but not limited to, epiretinal membrane, nonclearing vitreous hemorrhage, idiopathic macular hole, and rhegmatogenous retinal detachment (RD), and postoperative follow-up of at least 12 weeks. Exclusion criteria included history of prior vitrectomy, glaucoma filtration surgery, or administration of gas at expansile concentrations. Main outcome measures included best-corrected Snellen visual acuity (VA), intraocular pressure (IOP), intraoperative complications, and postoperative complications. RESULTS: Ninety-two patients met the inclusion criteria. The overall VA improved from 20/238 (range, 20/25 to hand motions [HM]) preoperatively to 20/82 (range, 20/20 to HM) postoperatively (P < .001). Each surgical indication experienced a statistically significant VA improvement. Intraoperative complications included retinal tears observed in two eyes (2.2%). Sclerotomy sutures were required intraoperatively in two eyes (2.2%). Postoperative complications included postoperative day 1 hypotony in six eyes (6.5%), a retinal tear in one eye (1.1%), and a recurrent RD in one eye (1.1%). No cases of endophthalmitis were observed. CONCLUSIONS: Intraoperative and postoperative complications were rare in this series of 23-gauge vitrectomy. Postoperative day 1 hypotony was the most common complication observed. All cases of postoperative hypotony resolved at postoperative week 1 without intervention. Retinal tear or detachment was an uncommon complication in the intraoperative and postoperative settings. Postoperative endophthalmitis was not noted in this case series.

ISIS-DME: a prospective, randomized, dose-escalation intravitreal steroid injection study for refractory diabetic macular edema.

PURPOSE: : To determine safety and efficacy of intravitreal triamcinolone acetonide (IVTA) for refractory clinically significant diabetic macular edema (DME). DESIGN: : Prospective, randomized, dose-escalation pilot study comparing single injection of 2 mg versus 4 mg doses of IVTA. METHODS: : Inclusion criteria included clinically significant DME persisting >/=3 months after maximal laser treatment and visual acuity 15 letters at 3 months in 23% (3/13) of 2 mg group and in 33% (5/15) of 4 mg group (P = 0.69), and 0% (0/11) and 21% (3/14) at 6 months, respectively (P = 0.23). Visual improvement was more likely in cystoid-type DME than diffuse DME. Intraocular pressure rise of >/=10 mmHg occurred in 19% (3/16) of 2 mg group and 41% (7/17) of 4 mg group. CONCLUSIONS: : Both doses of IVTA were well tolerated and had significant positive effects on refractory DME for short term. There were consistent trends throughout the study that suggest that a 4 mg IVTA may be more effective than a 2 mg dose. The benefit of IVTA was greater for cystoid-type DME.

Vitrectomy for a symptomatic lamellar macular hole.

PURPOSE: To investigate the surgical findings and outcomes after vitrectomy for a lamellar macular hole (LMH). DESIGN: Retrospective, consecutive, interventional case series. PARTICIPANTS: Twenty-seven patients (27 eyes) with a lamellar macular hole and central vision loss. INTERVENTION: All patients underwent 3-port vitrectomy with internal limiting membrane (ILM) stripping by one of the authors. Best-corrected visual acuity (BCVA) and appearance by optical coherence tomography (OCT) were obtained preoperatively and postoperatively. MAIN OUTCOME MEASURES: Preoperative and postoperative BCVA and OCT imaging. RESULTS: Visual acuity improved postoperatively in 25 of 27 eyes (93%), with a mean improvement of 3.2 Snellen lines. Preoperative and postoperative OCT images were obtained in 24 of 27 eyes (89%) and were judged to have improved or normalized in 22 of 24 (92%) of these patients. CONCLUSION: In patients with central visual loss from a lamellar macular hole, vitrectomy with ILM stripping appears to be a beneficial treatment.

Failure of intravitreal dexamethasone to diminish inflammation or retinal toxicity in an experimental model of Bacillus cereus endophthalmitis.

PURPOSE: To determine whether the usual clinical dose of intravitreal dexamethasone can attenuate intraocular inflammation and retinal necrosis in a rabbit model of fulminant Bacillus cereus endophthalmitis induced by crude exotoxins. METHODS: Thirty-six eyes from pigmented mongrel rabbits received intravitreal injections of varying concentrations of crude B. cereus exotoxins with or without concomitant injections of 400 microg of dexamethasone sodium phosphate (0.1% solution). After ophthalmoscopic examination at 4 or 18 hr postinjection, the animals were killed and histopathologic findings graded. RESULTS: Intraocular inflammation and retinal necrosis scores in eyes receiving both exotoxins and dexamethasone did not differ significantly from eyes receiving exotoxins alone for any exotoxin dose at 4 or 18 hr. The severity of retinal necrosis increased with toxin dose and was nearly maximal after 4 hr. Intraocular inflammation also generally increased with dose, but continued to increase until 18 hr. CONCLUSIONS: Standard clinical doses of intravitreal dexamethasone do not appear to attenuate the intraocular inflammatory or tissue response to secreted B. cereus exotoxins. Other treatment modalities including vitrectomy, to decrease exotoxin load, and exotoxin inhibitors may be necessary for the effective treatment of B. cereus endophthalmitis.

The artificial silicon retina microchip for the treatment of vision loss from retinitis pigmentosa.

OBJECTIVE: To determine the safety and efficacy of the artificial silicon retina (ASR) microchip implanted in the subretinal space to treat vision loss from retinitis pigmentosa. METHODS: The ASR microchip is a 2-mm-diameter silicon-based device that contains approximately 5000 microelectrode-tipped microphotodiodes and is powered by incident light. The right eyes of 6 patients with retinitis pigmentosa were implanted with the ASR microchip while the left eyes served as controls. Safety and visual function information was collected. RESULTS: During follow-up that ranged from 6 to 18 months, all ASRs functioned electrically. No patient showed signs of implant rejection, infection, inflammation, erosion, neovascularization, retinal detachment, or migration. Visual function improvements occurred in all patients and included unexpected improvements in retinal areas distant from the implant. MAIN OUTCOME MEASURES: Subjective improvements included improved perception of brightness, contrast, color, movement, shape, resolution, and visual field size. CONCLUSIONS: No significant safety-related adverse effects were observed. The observation of retinal visual improvement in areas far from the implant site suggests a possible generalized neurotrophic-type rescue effect on the damaged retina caused by the presence of the ASR. A larger clinical trial is indicated to further evaluate the safety and efficacy of a subretinally implanted ASR.

Clinical characteristics of central serous chorioretinopathy in women.

PURPOSE: To describe the clinical features of central serous chorioretinopathy (CSC) in women and identify factors predictive of complete recovery, moderate visual loss, and prolonged duration. DESIGN: Retrospective observational case series. PARTICIPANTS: Eighty-four eyes in 78 women with CSC seen in our practices between 1982 and 1999. METHODS: Univariate and multivariate statistical analysis. MAIN OUTCOME MEASURES: Analyses of three outcome parameters: complete recovery (recovery of visual acuity and complete symptom resolution), moderate visual acuity loss (final acuity less than 20/40), and duration of symptoms greater than 5 months. RESULTS: Sixty-two percent (52 of 84) achieved complete recovery over a median of 5 months (range, 2-108 months) and 88% (74 of 84) had a final vision of 20/40 or better. Patients with subretinal precipitates (P = 0.001), single occurrence (P = 0.002), absence of hormone replacement therapy (HRT) (P = 0.01), duration less than 5 months (P = 0.02), or absence of a pigment epithelial detachment (PED) (P = 0.05) were more likely to recover completely. Recurrence (P = 0.03) and lack of subretinal precipitates (P = 0.03) were associated with a final vision less than 20/40. Age older than 50 (P = 0.004) and the presence of a PED (P = 0.02) were associated with duration longer than 5 months. CONCLUSIONS: In women, CSC associated with subretinal precipitates, shorter duration, single occurrence, lack of HRT use, and absence of PED is more likely to resolve completely. CSC occurring in women older than 50 or associated with PED formation is more likely to take longer to resolve.