Ophthalmologic Presentations of Incontinentia Pigmenti.

Purpose: To characterize treatments and outcomes in incontinentia pigmenti. Methods: Cases of incontinentia pigmenti were consecutively identified from a retina practice. Inclusion criteria were patients with incontinentia pigmenti with at least 6 months of follow-up. All patients had a full ophthalmic examination, including imaging with widefield fundus photography and widefield fluorescein angiography. Eyes with areas of avascular retina were treated with laser photocoagulation (except for 1 eye with mild changes). Results: Thirty-six eyes of 18 patients with incontinentia pigmenti were included. The median age at presentation was 11 months. On presentation, 7 eyes had a visual acuity (VA) of 20/40 or better and 3 eyes had VA of 20/50 to 20/100. The remaining 26 eyes could fix and follow or had at least light perception (LP) VA given the patients' young age. Of the 36 eyes, 20 (56%) had retinal involvement. The mean follow-up for treated patients was 6.9 years. Seventy-four percent of treated eyes required 1 laser session only. No eye that received laser treatment subsequently developed a retinal detachment. Of the 26 eyes with initial fix-and-follow or LP VA, 12 had Snellen or Allen VA testing at follow-up. Nine of these eyes had a follow-up VA of 20/40 or better. Of 10 eyes with a Snellen or Allen VA recorded at the initial visit, 9 had a final VA that was the same or improved. Conclusions: Laser photocoagulation was effective in treating patients with retinal manifestations of incontinentia pigmenti. Except for 1 eye, VA remained stable at the final follow-up.

Opportunity Cost of Vitreoretinal Surgeries.

Purpose: To compare physician reimbursements for vitreoretinal surgeries with office-based patient care. Methods: A theoretical model was performed comparing physician work reimbursements for the 10 most common vitreoretinal surgeries with office-based work relative value units (wRVUs) that could have been generated during the same global time period. The reference physician was modeled at 40 patients per 8-hour workday. A lower volume physician and higher volume physician were modeled at 30 patients/day and 50 patients/day, respectively. The reimbursement rates and allocated times for surgery were based on the 2021 values set by Medicare, and the average wRVU per office visit was based on 2021 real-world data from the Vestrum Retinal Healthcare Database. Results: In the reference case, performing any of the 10 most common vitreoretinal surgeries was associated with an opportunity cost with a weighted mean of 49% (range, 40%-68%) relative to lost office productivity. The Centers for Medicare & Medicaid Services (CMS) allocated a weighted mean intraservice time of 73 minutes; however, the reference physician would have to complete the surgery with a weighted average of 5 minutes (range, -31-12 minutes) for surgical wRVUs to equal office-based reimbursements. Performing these 10 surgeries was associated with a 25% opportunity cost even for the lower volume physician and 61% for the higher volume physician. Probability sensitivity analysis with a range of conditions identified opportunity costs from surgery in over 99% of simulated scenarios. Conclusions: Medicare reimbursements for the physician work component of vitreoretinal surgeries represented a significant opportunity cost for the physician relative to office-based patient care of equivalent time, especially for busier physicians. The model did not explore practice overhead and professional liability insurance, which are factored separately by CMS and may influence the opportunity cost depending on utilization. The average threshold surgery times for surgical reimbursements to equal office-based reimbursements may be difficult to achieve.

Survey of Retina Specialists' Attitudes and Practice Patterns of Screening and Management of Candida Endophthalmitis.

PURPOSE: To understand retina specialists' attitudes and practice patterns for screening for and managing Candida endophthalmitis and any impact of the COVID-19 pandemic on these practice patterns. METHODS: A survey was developed on Survey Monkey and distributed to ASRS regular members via email in April 2021. RESULTS: The survey had 231 respondents, of whom 169 (73%) performed inpatient consultations. Ninety percent responded that they do not recommend routinely screening asymptomatic patients with candidemia. For unresponsive patients with candidemia that lack visible signs of endophthalmitis, 65% did not recommend routine screening.However, 85% reported their affiliated hospitals did not have a policy to defer such screening consultations; this proportion did not significantly change when asked if a policy was implemented in response to the COVID-19 pandemic.For patients with a dilated examination without signs of endophthalmitis, 89% surveyed recommended continuing systemic antifungals and reconsult PRN, while the remainder recommended repeat examinations until off antifungals. For initial management of Candida endophthalmitis, 55% indicated systemic antifungals only; 43% indicated systemic antifungals with tap & inject, and 2% indicated systemic antifungals with vitrectomy and intravitreal antifungals. CONCLUSION: A discordance exists between the prevailing opinion among retina specialists against routine Candida endophthalmitis screening and hospital consultation policies, which were not significantly impacted by the COVID-19 pandemic. In cases of diagnosed endogenous endophthalmitis, slightly more than half of surveyed retina specialists would not initiate additional treatment beyond systemic antifungals while just under half surveyed recommended initial tap and inject in addition to systemic antifungals.

The Broader Economic Value of Treatment for Diabetic Macular Edema.

OBJECTIVE: To simulate economic outcomes for individuals with diabetic macular edema (DME) and estimate the economic value of direct and indirect benefits associated with DME treatment. RESEARCH DESIGN AND METHODS: Our study pairs individual and cohort analyses to demonstrate the value of treatment for DME. We used a microsimulation model to simulate self-reported vision (SRV) and economic outcomes for individuals with DME. Four scenarios derived from clinical trial data were simulated and compared for a lifetime horizon: untreated, anti-VEGF therapy, laser, and steroid. To quantify the relative magnitude of costs and benefits of DME treatment in the U.S., we used a cohort-level analysis based on real-world treatment parameters derived from published data. RESULTS: In the model, excellent/good SRV roughly corresponded to 20/40 or better visual acuity. A representative 51-year-old treated for DME would spend 30-35% additional years with excellent/good SRV and 29-32% fewer years with fair/poor SRV relative to being untreated. A treated individual would experience 4-5% greater life expectancy and 9-13% more quality-adjusted life-years. Indirect benefits from treatment included 6-9% more years working, 12-19% greater lifetime earnings, and 8-16% fewer years with disability. For the U.S. DME cohort (1.1. million people), total direct benefit was $63.0 billion over 20 years, and total indirect benefit was $4.8 billion. Net value (benefit - cost) of treatment ranged from $28.1 billion to $52.8 billion. CONCLUSIONS: Treatment for DME provides economic value to patients and society through improved vision, life expectancy, and quality of life and indirectly through improved employment and disability outcomes.

Amniotic Membrane Patching to Assist Closure of Recalcitrant Macular Holes.

BACKGROUND AND OBJECTIVE: This study reports a case series of patients with persistent macular holes (MHs) who underwent human amniotic membrane subretinal placement to achieve successful anatomic MH closure. PATIENTS AND METHODS: This was a retrospective case series of patients with persistently open full-thickness MHs who underwent human amniotic membrane placement. Patients were observed up to 6 months postoperatively. RESULTS: Ten patients were included. The mean preoperative best-corrected visual acuity was 1.6 logMAR (20/800). Postoperatively, mean best-corrected visual acuity improved to 1.3 logMAR (20/400) at 1 month and 1.1 logMAR (20/250) by the 3- and 6-month visits. In all cases, the MH appeared closed at the 1-week visit and remained closed at their last follow-up. Optical coherence tomography showed closure in all cases. No adverse events were reported. CONCLUSIONS: Human amniotic membrane sub-retinal placement may serve as a useful surgical technique to assist in the closure of recalcitrant macular holes. [Ophthalmic Surg Lasers Imaging Retina 2023;54:218-222.].

Stickler and Wagner Syndrome in African Americans.

BACKGROUND: Stickler (STL) and Wagner (WGN) syndromes are rare inherited vitreoretinopathies associated with retinal detachments (RD). There is a paucity of case reports describing these diseases in African American patients. METHODS: An IRB-approved, retrospective chart review of African American patients with genetically proven ocular-only STL or WGN was performed, and 6 patients were identified. RESULTS: Three patients had a COL2A1 mutation, two had a COL11A1 mutation, and one had a VCAN mutation. None had Pierre Robin facies. All were myopes with lattice degeneration and five had RD. Three underwent RD repair with vitrectomy (PPV), scleral buckle (SB), endolaser (EL), and silicone oil (SO). Two received laser retinopexy for localized RD and one received a prophylactic SB with 360° peripheral laser retinopexy. CONCLUSION: STL and WGN should be considered in myopic African American patients with lattice degeneration, giant retinal tears, abnormal vitreous, or spontaneous RD. Prophylactic laser treatment and aggressive surgical treatment of RD should be considered. [Ophthalmic Surg Lasers Imaging Retina 2023;54:97-101.].

Topical Dexamethasone as an Adjuvant to Mineralocorticoid Receptor Antagonists for the Treatment of Recalcitrant Central Serous Chorioretinopathy.

BACKGROUND AND OBJECTIVE: A previous report demonstrated efficacy of mineralocorticoid antagonist with adjuvant topical dexamethasone (MRA+DEX) in resolving subretinal fluid (SRF) in a chronic central serous chorioretinopathy (CSCR) patient. This pilot study investigates the use of MRA+DEX to treat recalcitrant, chronic CSCR patients. STUDY DESIGN: Retrospective review of chronic, recalcitrant CSCR patients unresponsive to MRA alone who were treated with MRA+DEX and followed for up to 3 months. Apical SRF thickness and visual acuity were measured. RESULTS: Ten eyes of eight chronic, recalcitrant patients were included with an average follow-up of 109 days. Mean percent reduction in apical fluid thickness at one month and at last follow-up after adding dexamethasone (DEX) was 33% and 52%, respectively. Five eyes (50%) achieved complete resolution of SRF. Three eyes (30%) showed partial response and two (20%) eyes had no response. There was no significant change in visual acuity. CONCLUSIONS: MRA+DEX decreased SRF in some recalcitrant, chronic CSCR patients. Large prospective studies are needed to evaluate the utility of MRA+DEX in these chronic CSCR patients. [Ophthalmic Surg Lasers Imaging Retina 2022;53:659-665.].

Efficacy, durability, and safety of intravitreal faricimab up to every 16 weeks for neovascular age-related macular degeneration (TENAYA and LUCERNE): two randomised, double-masked, phase 3, non-inferiority trials.

BACKGROUND: Faricimab is a bispecific antibody that acts through dual inhibition of both angiopoietin-2 and vascular endothelial growth factor A. We report primary results of two phase 3 trials evaluating intravitreal faricimab with extension up to every 16 weeks for neovascular age-related macular degeneration (nAMD). METHODS: TENAYA and LUCERNE were randomised, double-masked, non-inferiority trials across 271 sites worldwide. Treatment-naive patients with nAMD aged 50 years or older were randomly assigned (1:1) to intravitreal faricimab 6·0 mg up to every 16 weeks, based on protocol-defined disease activity assessments at weeks 20 and 24, or aflibercept 2·0 mg every 8 weeks. Randomisation was performed through an interactive voice or web-based response system using a stratified permuted block randomisation method. Patients, investigators, those assessing outcomes, and the funder were masked to group assignments. The primary endpoint was mean change in best-corrected visual acuity (BCVA) from baseline averaged over weeks 40, 44, and 48 (prespecified non-inferiority margin of four letters), in the intention-to-treat population. Safety analyses included patients who received at least one dose of study treatment. These trials are registered with ClinicalTrials.gov (TENAYA NCT03823287 and LUCERNE NCT03823300). FINDINGS: Across the two trials, 1329 patients were randomly assigned between Feb 19 and Nov 19, 2019 (TENAYA n=334 faricimab and n=337 aflibercept), and between March 11 and Nov 1, 2019 (LUCERNE n=331 faricimab and n=327 aflibercept). BCVA change from baseline with faricimab was non-inferior to aflibercept in both TENAYA (adjusted mean change 5·8 letters [95% CI 4·6 to 7·1] and 5·1 letters [3·9 to 6·4]; treatment difference 0·7 letters [-1·1 to 2·5]) and LUCERNE (6·6 letters [5·3 to 7·8] and 6·6 letters [5·3 to 7·8]; treatment difference 0·0 letters [-1·7 to 1·8]). Rates of ocular adverse events were comparable between faricimab and aflibercept (TENAYA n=121 [36·3%] vs n=128 [38·1%], and LUCERNE n=133 [40·2%] vs n=118 [36·2%]). INTERPRETATION: Visual benefits with faricimab given at up to 16-week intervals demonstrates its potential to meaningfully extend the time between treatments with sustained efficacy, thereby reducing treatment burden in patients with nAMD. FUNDING: F Hoffmann-La Roche.

The Influence of Universal Face Mask Use on Endophthalmitis Risk after Intravitreal Anti-Vascular Endothelial Growth Factor Injections.

PURPOSE: Routine use of face masks for patients and physicians during intravitreal anti-vascular endothelial growth factor (VEGF) injections has increased with the emergence of the coronavirus disease 2019 pandemic. This study evaluates the impact of universal face mask use on rates and outcomes of post-injection endophthalmitis (PIE). DESIGN: Retrospective, multicenter, comparative cohort study. PARTICIPANTS: Eyes receiving intravitreal anti-VEGF injections from October 1, 2019, to July 31, 2020, at 12 centers. METHODS: Cases were divided into a "no face mask" group if no face masks were worn by the physician or patient during intravitreal injections or a "universal face mask" group if face masks were worn by the physician, ancillary staff, and patient during intravitreal injections. MAIN OUTCOME MEASURES: Rate of endophthalmitis, microbial spectrum, and visual acuity (VA). RESULTS: Of 505 968 intravitreal injections administered in 110 547 eyes, 85 of 294 514 (0.0289%; 1 in 3464 injections) cases of presumed endophthalmitis occurred in the "no face mask" group, and 45 of 211 454 (0.0213%; 1 in 4699) cases occurred in the "universal face mask" group (odds ratio [OR], 0.74; 95% confidence interval [CI], 0.51-1.18; P = 0.097). In the "no face mask" group, there were 27 cases (0.0092%; 1 in 10 908 injections) of culture-positive endophthalmitis compared with 9 cases (0.004%; 1 in 23 494) in the "universal face mask" group (OR, 0.46; 95% CI, 0.22-0.99; P = 0.041). Three cases of oral flora-associated endophthalmitis occurred in the "no face mask" group (0.001%; 1 in 98 171 injections) compared with 1 (0.0005%; 1 in 211 454) in the "universal face mask" group (P = 0.645). Patients presented a mean (range) 4.9 (1-30) days after the causative injection, and mean logarithm of the minimum angle of resolution (logMAR) VA at endophthalmitis presentation was 2.04 (~20/2200) for "no face mask" group compared with 1.65 (~20/900) for the "universal face mask" group (P = 0.022), although no difference was observed 3 months after treatment (P = 0.764). CONCLUSIONS: In a large, multicenter, retrospective study, physician and patient face mask use during intravitreal anti-VEGF injections did not alter the risk of presumed acute-onset bacterial endophthalmitis, but there was a reduced rate of culture-positive endophthalmitis. Three months after presentation, there was no difference in VA between the groups.

Traumatic Retinal Detachment in Patients with Self-Injurious Behavior: An International Multicenter Study.

PURPOSE: To describe the clinical characteristics, surgical outcomes, and management recommendations in patients with traumatic rhegmatogenous retinal detachment (RRD) resulting from self-injurious behavior (SIB). DESIGN: International, multicenter, retrospective, interventional case series. PARTICIPANTS: Patients with SIB from 23 centers with RRD in at least 1 eye. METHODS: Clinical histories, preoperative assessment, surgical details, postoperative management, behavioral intervention, and follow-up examination findings were reviewed. MAIN OUTCOME MEASURES: The rate of single-surgery anatomic success (SSAS) was the primary outcome. Other outcomes included new RRD in formerly attached eyes, final retinal reattachment, and final visual acuity. RESULTS: One hundred seven eyes with RRDs were included from 78 patients. Fifty-four percent of patients had bilateral RRD or phthisis bulbi in the fellow eye at final follow-up. The most common systemic diagnoses were autism spectrum disorder (35.9%) and trisomy 21 (21.8%) and the most common behavior was face hitting (74.4%). The average follow-up time was 3.3 ± 2.8 years, and surgical outcomes for operable eyes were restricted to patients with at least 3 months of follow-up (81 eyes). Primary initial surgeries were vitrectomy alone (33.3%), primary scleral buckle (SB; 26.9%), and vitrectomy with SB (39.7%), and 5 prophylactic SBs were placed. Twenty-three eyes (21.5%) with RRDs were inoperable. The SSAS was 23.1% without tamponade (37.2% if including silicone oil), and final reattachment was attained in 80% (36.3% without silicone oil tamponade). Funnel-configured RRD (P = 0.006) and the presence of grade C proliferative vitreoretinopathy (P = 0.002) correlated with re-detachment. The use of an SB predicted the final attachment rate during the initial surgery (P = 0.005) or at any surgery (P = 0.008. These associations held if restricting to 64 patients with ≥12 months followup. Anatomic reattachment correlated with better visual acuity (P < 0.001). CONCLUSIONS: RRD resulting from SIB poses therapeutic challenges because of limited patient cooperation, bilateral involvement, chronicity, and ongoing trauma in vulnerable and neglected patients. The surgical success rates were some of the lowest in the modern retinal detachment literature. The use of an SB may result in better outcomes, and visual function can be restored in some patients.

Long-Term Follow-Up of Retinal Detachment Repair in Patients With Stickler Syndrome.

BACKGROUND AND OBJECTIVE: To report the long-term anatomic and visual outcomes of patients with Stickler syndrome undergoing retinal detachment (RD) surgery. PATIENTS AND METHODS: Retrospective, interventional, consecutive case series of patients with Stickler syndrome undergoing RD repair from 1999 to 2017 at the Long Island Vitreoretinal Consultants, New York. Retinal attachment status and visual acuity (VA) at 1-year and last follow-up were assessed. RESULTS: Successful reattachment was achieved in 28 of 29 eyes (97%) with an average of 2.3 surgeries (including silicone oil removal surgeries). Redetachment after the first surgery occurred in 13 eyes (45%). Mean Snellen VA at initial presentation, 1-year follow-up, and last follow-up were 20/289, 20/118 (P = .012), and 20/103 (P = .022), respectively. CONCLUSIONS: Anatomic success can be achieved in most eyes. However, redetachments are common, and multiple surgeries are often required. Reasonable visual recovery is possible in many eyes. [Ophthalmic Surg Lasers Imaging Retina. 2020;51:612-616.].

Surgical Outcomes of Epiretinal Membrane Removal Due to Combined Hamartoma of the Retina and RPE.

BACKGROUND AND OBJECTIVE: To evaluate the surgical outcomes of epiretinal membrane (ERM) associated with combined hamartoma of the retina and retinal pigment epithelium (CHRRPE) after vitrectomy and membrane peel. PATIENTS AND METHODS: A retrospective review of 15 patients who underwent pars plana vitrectomy with membrane peeling. No plasmin enzyme was used. RESULTS: The mean age at surgery was 10 years old, with an average follow-up of 5.7 years. The average preoperative visual acuity (VA) was 20/514. The average postoperative VA was 20/138 (P = .0251) at 1-year follow-up and 20/89 (P = .0025) on the latest exam on final follow-up. VA was improved in 14 patients (93%) and deteriorated in one patient (7%). All 15 patients (100%) had improvement of retinal/macular anatomy postoperatively. CONCLUSION: In the treatment of patients with ERM due to CHRRPE, vitrectomy with membrane peeling without plasmin injection can result in improved VA and retinal structure. [Ophthalmic Surg Lasers Imaging Retina. 2020;51:546-554.].

Efficacy of Every Four Monthly and Quarterly Dosing of Faricimab vs Ranibizumab in Neovascular Age-Related Macular Degeneration: The STAIRWAY Phase 2 Randomized Clinical Trial.

Importance: Faricimab neutralizes angiopoietin-2 and vascular endothelial growth factor A via both simultaneous and independent binding. Objective: To evaluate extended dosing with faricimab, the first bispecific antibody designed for intraocular use, in patients with neovascular age-related macular degeneration. Design, Setting, and Participants: This phase 2 randomized clinical trial was a 52-week multicenter, active comparator-controlled, parallel-group study. Study participants were enrolled in 25 sites in the US from January and March 2017 with treatment-naive choroidal neovascularization secondary to neovascular age-related macular degeneration and best-corrected visual acuity (BCVA) Early Treatment Diabetic Retinopathy Study letter score of 73 (approximate Snellen equivalent, 20/40) to 24 (approximate Snellen equivalent, 20/320). Analysis began January 2017 and ended March 2018. Interventions: Participants were randomized 1:2:2 to receive intravitreal ranibizumab, 0.5 mg, every 4 weeks or faricimab, 6.0 mg, every 12 or 16 weeks. Participants in the faricimab arms initially received 4 monthly injections of faricimab. No rescue injections were allowed. Participants randomized to dosing every 16 weeks were assessed for disease activity at week 24 using prespecified criteria. Those with no active disease continued dosing every 16 weeks through trial end; participants with disease activity continued received dosing every 12 weeks. Main Outcomes and Measures: Mean change in BCVA from baseline at week 40. Results: Of 76 participants enrolled (mean [SD] age, 78.5 [8.5] years; age range, 56-94 years; 41 women [58%]; 69 white [97%]), 16 (21.0%) were randomized to ranibizumab every 4 weeks, 29 (38.2%) to faricimab every 12 weeks, and 31 (40.8%) to faricimab every 16 weeks. At week 24, 12 weeks after their last initiation injection, 65% (36 of 55) of all faricimab-treated participants had no disease activity. At week 40, adjusted mean BCVA gains from baseline (Early Treatment Diabetic Retinopathy Study letters) were +11.4 (80% CI, 7.8-15.0), +9.3 (80% CI, 6.4-12.3), and +12.5 (80% CI, 9.9-15.1) for the ranibizumab every 4 weeks, faricimab every 12 weeks, and faricimab every 16 weeks arms, respectively. Participants received a mean (SD) total of 12.9 (0.25), 6.7 (0.91), and 6.2 (0.93) injections, for the ranibizumab every 4 weeks, faricimab every 12 weeks, and faricimab every 16 weeks arms, respectively, through week 52. The secondary BCVA and anatomical imaging end points supported the primary end point and were comparable with ranibizumab every 4 weeks. No new or unexpected safety signals were identified. Conclusions and Relevance: At week 52, faricimab dosing every 16 weeks and every 12 weeks resulted in maintenance of initial vision and anatomic improvements comparable with monthly ranibizumab. These results suggest a role for simultaneous neutralization of angiopoietin-2 and vascular endothelial growth factor A in providing sustained efficacy through extended durability, warranting further investigation. Trial Registration: ClinicalTrials.gov Identifier: NCT03038880.

A Multicenter Study of Pediatric Macular Holes: Surgical Outcomes With Microincisional Vitrectomy Surgery.

Purpose: Pediatric macular holes occur often related to trauma and rarely require surgical intervention. The purpose of the present study was to evaluate outcomes of microincisional vitrectomy surgery. Methods: A multicenter retrospective consecutive case series was conducted of pediatric patients undergoing surgery for macular hole repair. Results: A total of 31 eyes from 8 centers were included in this study. The mechanism of macular hole development was blunt trauma in 30 eyes (97%) and industrial laser in 1 eye (3%). The rate of anatomic closure after primary vitrectomy was 81% (25 eyes); the final anatomic closure rate after a secondary vitrectomy was 94% (29 eyes). There was a statistically significant improvement in visual acuity from initial presentation (20/164) to final follow-up (20/100) (P = .009). Conclusions: Microincisional vitrectomy surgery for pediatric macular holes results in substantial anatomic success and modest improvement in visual acuity.

TRAUMATIC MACULAR HOLE CLOSURE AND VISUAL IMPROVEMENT AFTER TOPICAL NONSTEROIDAL ANTIINFLAMMATORY DRUG TREATMENT.

PURPOSE: To report a case of pediatric traumatic macular hole that closed with visual improvement after treatment with topical ketorolac. METHODS: Retrospective case report. RESULTS: A 15-year-old girl presented with persistent left blurred vision after being hit with a soccer ball 2 months before. Visual acuity was 20/40 with a full-thickness macular hole with cystoid macular edema. After treatment with ketorolac 0.4% four times a day for a month, the hole closed with resolution of the cystoid macular edema but some remaining subretinal fluid. The ketorolac was tapered over the following month, and the subretinal fluid resolved during the subsequent months. At 10 months after initial presentation, patient's vision was 20/20 with a normal foveal contour, no subretinal fluid, and minimal ellipsoid zone disruption. CONCLUSION: Topical nonsteroidal antiinflammatory drug treatment may play a role in the resolution of traumatic macular holes with cystoid macular edema.

Aflibercept-Related Sterile Intraocular Inflammation Outcomes.

PURPOSE: A recent increase in sterile intraocular inflammation after aflibercept (EYLEA; Regeneron Pharmaceuticals, Inc, Tarrytown, NY) injection was reported to the American Society of Retina Specialists' Research and Safety in Therapeutics Committee. This study describes their clinical characteristics and outcomes. DESIGN: Case series. PARTICIPANTS: Sixty-eight eyes of 66 patients (97% reported from May 2017 through February 2018). METHODS: Exclusion criteria were intravitreal antibiotic injection and follow-up of less than 7 days. Diagnosis was at each physician's discretion. MAIN OUTCOME MEASURES: Presenting signs and symptoms, injection characteristics, management details, and visual outcomes. RESULTS: Mean time to presentation was 2.6 days (median, 2.0 days; range, 0-15 days). Symptoms included blurry vision (93%), floaters (60%), pain (44%), severe pain (6%), and photophobia (19%). Mean visual acuities before and after injection were 20/50 and 20/178, respectively. All patients showed intraocular inflammation: 24% with only vitritis, 16% with only anterior chamber reaction, and 60% with both. Less common findings included keratic precipitates (22%), corneal edema (13%), conjunctival injection (10%), chemosis (4%), hypopyon (4%), and fibrin (3%). Two patients were affected bilaterally. Treatment included topical steroids (93%), with 1% supplemented by oral steroids. Inflammation resolved in 79% at study completion (mean, 34 days; range, 7-105 days; 51% resolved by 1 month). This group's mean final visual acuity (VA) was 20/55, and 15% lost 2 lines or more. This vision loss was associated with shorter time to presentation (P < 0.0001), magnitude of decrease in presenting VA (P = 0.0004), presence of fibrin (P = 0.02), and trended toward receiving only observation (P = 0.10). There were no other presenting factors that significantly affected visual outcome. In patients with unresolved inflammation at the final visit, mean follow-up was 29 days, and mean final VA was 20/118. Overall, 26 aflibercept lots were involved. CONCLUSIONS: This is the largest study of aflibercept-related sterile intraocular inflammation, and is the only large report to exclude eyes injected with intraocular antibiotics. Most patients presented early with decreased VA and intraocular inflammation, but without injection, hypopyon, fibrin, or severe pain. Final VA remained decreased in a significant minority of patients.

Long-Term Outcomes of Total Exudative Retinal Detachments in Stage 3B Coats Disease.

PURPOSE: To evaluate the long-term outcomes of treatment of total exudative retinal detachments (ERDs) secondary to Coats disease (stage 3B) and the role of vitrectomy. DESIGN: Retrospective, observational case series. PARTICIPANTS: A total of 16 eyes in 16 patients undergoing treatment for total ERDs secondary to Coats disease with at least 5 years of follow-up. METHODS: We reviewed the records of patients with stage 3B Coats disease. The interventions, including the timing of vitrectomy if used, and clinical course were recorded. MAIN OUTCOME MEASURES: The primary outcome measures were visual acuity at the most recent appointment, whether there was progression to neovascular glaucoma (NVG) or phthisis bulbi, and need for enucleation. RESULTS: All patients received ablative treatment (photocoagulation or cryotherapy), with 8 having scleral buckling (SB) and 6 having external drainage of subretinal fluid (XD). Of the 12 patients who had pars plana vitrectomy (PPV), 8 had early PPV (EV) in the first year after presenting, and 4 of 8 in the expectant management group had late PPV (late vitrectomy) at a mean of 4.3 years post-presentation for treatment of significant traction retinal detachment (TRD). The other 4 patients of 8 in the expectant management group did not require vitrectomy. Mean follow-up overall was 9 1/2 years. At the date of last follow-up, 50% had no light perception or light perception vision, which was consistent across the subgroups that underwent EV (4/8), late vitrectomy (2/4), or no PPV (2/4). A total of 4 of 16 patients had progression to NVG or phthisis, 1 of whom required enucleation. CONCLUSIONS: In this retrospective series of patients with Stage 3B Coats disease, ablative therapy with a combination of PPV, XD, or SB was effective in preventing progression to NVG or phthisis in the majority of patients, thus preserving the globe. Half of the patients (4/8) in this series who did not undergo PPV in the early vitrectomy group developed late-onset TRD, suggesting a possible role for early prophylactic vitrectomy with possible SB and XD; however, this is balanced by the other half (4/8) in the expectant management group who did not require any vitrectomy.

COMPLICATED CONGENITAL RETINOSCHISIS.

PURPOSE: To describe the treatment and natural history of a patient with complicated congenital retinoschisis. METHODS: A retrospective case report. A 10-month-old boy with congenital retinoschisis presented with tractional retinal detachments and foveal schisis in both eyes. RESULTS: On presentation, vision was decreased in both eyes with presumed amblyopia of the left eye. Funduscopic examination revealed bilateral foveal schisis and tractional retinal detachment involving the macula. Follow-up examination revealed superior retinal dragging and peripheral ischemia on fluorescein angiogram in both eyes. Nine months after presentation, combined rhegmatogenous and tractional retinal detachment developed in the right eye and was treated by scleral buckle. After vitrectomy for nonclearing vitreous hemorrhage in the left eye, a combined rhegmatogenous and tractional retinal detachment developed. Vitrectomy and lensectomy with silicone oil was performed. At 6 years of follow-up, both retinas were attached and foveal schisis had resolved. CONCLUSION: Sight threatening complications of congenital retinoschisis include retinal detachment and vitreous hemorrhage. Vitrectomy and/or scleral buckling may prevent progression of vision loss and promote resolution of schisis.

Comparison of Ranibizumab 0.5 mg Versus 1.0 mg for the Treatment of Patients With Clinically Significant Diabetic Macular Edema: A Randomized, Clinical Trial.

BACKGROUND AND OBJECTIVE: To compare ranibizumab (Lucentis; Genentech, South San Francisco, CA) 0.5 mg and 1.0 mg for the treatment of clinically significant diabetic macular edema (CSDME). PATIENTS AND METHODS: This was a 12-month, prospective, single-masked, randomized clinical trial. Patients with CSDME secondary to diabetic retinopathy were randomized to receive 0.5 mg or 1.0 mg of ranibizumab by intravitreal injection once monthly for 3 months and then once every other month as needed. RESULTS: Patients received a mean of 6.5 injections in each group during the course of this 12-month study. The mean change in Early Treatment Diabetic Retinopathy Study visual acuity from baseline to month 12 was +3.8 letters in the ranibizumab 0.5-mg group (n = 23) and +7.9 letters in the 1.0-mg group (n = 23; P = .92 vs. 0.5 mg). Central foveal thickness (CFT) significantly decreased from baseline to month 12 in both dose groups. CONCLUSION: Treatment of CSDME with ranibizumab resulted in a statistically significant improvement in visual acuity (ranibizumab 1.0 mg) and decrease in CFT and macular volume (ranibizumab 0.5 mg and 1.0 mg) from baseline to 12 months. [Ophthalmic Surg Lasers Imaging Retina. 2016;47:536-543.].

Immediate Sequential Bilateral Pediatric Vitreoretinal Surgery: An International Multicenter Study.

PURPOSE: To determine the feasibility and safety of bilateral simultaneous vitreoretinal surgery in pediatric patients. DESIGN: International, multicenter, interventional, retrospective case series. PARTICIPANTS: Patients 17 years of age or younger from 24 centers worldwide who underwent immediate sequential bilateral vitreoretinal surgery (ISBVS)-defined as vitrectomy, scleral buckle, or lensectomy using the vitreous cutter-performed in both eyes sequentially during the same anesthesia session. METHODS: Clinical history, surgical details and indications, time under anesthesia, and intraoperative and postoperative ophthalmic and systemic adverse events were reviewed. MAIN OUTCOME MEASURES: Ocular and systemic adverse events. RESULTS: A total of 344 surgeries from 172 ISBVS procedures in 167 patients were included in the study. The mean age of the cohort was 1.3±2.6 years. Nonexclusive indications for ISBVS were rapidly progressive disease (74.6%), systemic morbidity placing the child at high anesthesia risk (76.0%), and residence remote from surgery location (30.2%). The most common diagnoses were retinopathy of prematurity (ROP; 72.7% [P < 0.01]; stage 3, 4.8%; stage 4A, 44.4%; stage 4B, 22.4%; stage 5, 26.4%), familial exudative vitreoretinopathy (7.0%), abusive head trauma (4.1%), persistent fetal vasculature (3.5%), congenital cataract (1.7%), posterior capsular opacification (1.7%), rhegmatogenous retinal detachment (1.7%), congenital X-linked retinoschisis (1.2%), Norrie disease (2.3%), and viral retinitis (1.2%). Mean surgical time was 143±59 minutes for both eyes. Higher ROP stage correlated with longer surgical time (P = 0.02). There were no reported intraoperative ocular complications. During the immediate postoperative period, 2 eyes from different patients demonstrated unilateral vitreous hemorrhage (0.6%). No cases of endophthalmitis, choroidal hemorrhage, or hypotony occurred. Mean total anesthesia time was 203±87 minutes. There were no cases of anesthesia-related death, malignant hyperthermia, anaphylaxis, or cardiac event. There was 1 case of reintubation (0.6%) and 1 case of prolonged oxygen desaturation (0.6%). Mean follow-up after surgery was 103 weeks, and anatomic success and globe salvage rates were 89.8% and 98.0%, respectively. CONCLUSIONS: This study found ISBVS to be a feasible and safe treatment paradigm for pediatric patients with bilateral vitreoretinal pathologic features when repeated general anesthesia is undesirable or impractical.