Long-Term Control of Retinal Thickness Variability and Vision Following the 0.19 mg Fluocinolone Acetonide Implant.

Purpose: To assess the impact of retinal thickness variability (RTV) control on visual and treatment burden outcomes in patients with diabetic macular edema (DME) who received the 0.19 mg fluocinolone acetonide (FAc) intravitreal implant (Iluvien, Alimera Sciences). Methods: This post hoc analysis examined the outcomes of a 3-year, phase 4, nonrandomized, open-label observational study. Retinal thickness was measured as central subfield thickness (CST). RTV was quantified by CST area under the curve (CST-AUC), retinal thickness amplitude (RTA), and retinal thickness standard deviation (RTSD). Visual outcomes were measured as best-corrected visual acuity (BCVA), and treatment burden was measured as the number of yearly supplemental DME treatments. Results: The percentage of eyes with a CST ≤300 µm fluctuated throughout the study but was significantly increased relative to baseline at 36 months (baseline: 32.9% vs 36 months: 46.8%; P < .05). FAc significantly reduced RTV in all measures more than 36 months (P < .0001). When divided into quartiles, eyes with the best RTV control post FAc had the greatest BCVA gains and improved disease control (ie, reduced need for supplemental therapy). The last-observed BCVA letter score exhibited linear correlations with CST-AUC (R2 = -0.100), RTA (R2 = -0.125), and RTSD (R2 = -0.162). A multivariate linear regression with baseline BCVA as a covariate displayed improved correlations with the last-observed BCVA, CST-AUC (R2 = -0.448), RTA (R2 = -0.432), and RTSD (R2 = -0.436). Conclusions: The sustained corticosteroid release of the 0.19 mg FAc implant reduced RTV in patients with DME, which directly correlated with significantly improved vision and a reduced supplemental treatment burden.

INTRAOPERATIVE BLEB BEHAVIOR IN SUBRETINAL GENE AUGMENTATION THERAPY FOR INHERITED RETINAL DISEASES.

PURPOSE: In subretinal gene therapy for inherited retinal diseases (IRDs), blebs may not propagate predictably in the direction of the injection cannula. We evaluated factors that influenced bleb propagation among various IRDs. METHODS: Retrospective review of all subretinal gene therapy procedures performed by a single surgeon between September 2018 and March 2020 for various IRDs. Main outcome measures were directional bias of bleb propagation and intraoperative foveal detachment. RESULTS: Desired injection volumes and/or foveal treatment were successfully achieved in all 70 eyes of 46 patients with IRD regardless of IRD indication. Bullous foveal detachment was associated with retinotomy closer to the fovea, posterior bleb bias, and greater bleb volumes ( P < 0.01). Blebs biased anteriorly or posteriorly based on disease indication ( P = 0.04) and age ( P < 0.001). Retinotomy location ≤ 3.7 mm (approximately two disk diameters) from the fovea favored foveal detachment ( P < 0.001). Multiple retinotomies and blebs allowed greater surface area coverage in some eyes, but intersecting blebs did not propagate further. CONCLUSION: Bleb formation and propagation are predictable based on patient age, retinotomy location, disease indication, and how tangentially fluid is directed into the subretinal space.

Orbital Dynamics and Efficacy of Retrobulbar Anesthesia With and Without Hyaluronidase in Vitreoretinal Surgery.

Purpose: To compare retrobulbar anesthesia injection (RAI) with hyaluronidase and without hyaluronidase in vitreoretinal surgery using clinical efficacy measures and orbital manometry (OM). Methods: This prospective randomized double-masked study enrolled patients who had surgery using an 8 mL RAI with or without hyaluronidase. Outcome measures were clinical block effectiveness (akinesia, pain scores, need for supplemental anesthetic or sedative medications) and orbital dynamics assessed by OM before and up to 5 minutes after RAI. Results: Twenty-two patients received RAI with hyaluronidase (Group H+), and 25 received RAI without hyaluronidase (Group H-). Baseline characteristics were well matched. No differences in clinical efficacy were found. OM showed no difference in preinjection orbital tension (4 ± 2 mm Hg in both groups) or calculated orbital compliance (0.6 ± 0.3 mL/mm Hg, Group H+; 0.5 ± 0.2 mL/mm Hg, Group H-) (P = .13). After RAI, the peak orbital tension was 23 ± 15 mm Hg in Group H+ and 24 ± 9 mm Hg in Group H- (P = .67); it declined more rapidly in Group H+. Orbital tension at 5 minutes was 6 ± 3 mm Hg in Group H+ and 11 ± 5 mm Hg in Group H- (P = .0008). Conclusions: OM showed faster resolution of post-RAI orbital tension elevation with hyaluronidase; however, there were no clinically evident differences between groups. Thus, 8 mL RAI with or without hyaluronidase is safe and can achieve excellent clinical results. Our data do not support the routine use of hyaluronidase with RAI.

Intraocular methotrexate for epithelial downgrowth: long-term outcomes in a multicentre case series.

BACKGROUND/AIMS: Sheet-like type of epithelial downgrowth (EDG) is not easily amenable to surgical excision. We describe long-term outcomes in patients with EDG treated with intraocular methotrexate (MTX). METHODS: This is a retrospective, multicentric case series including 10 eyes (nine patients) treated with intraocular MTX for sheet-like EDG. Relevant ocular history, previous EDG treatments, MTX injection regimen, long-term outcomes and complications are reported. RESULTS: All cases were associated with intraocular surgery. Most patients were treated with 400 µm/0.1 mL MTX injections with a starting frequency of two times per week or weekly injections. Mean and SD number of injections per eye was 16±13 injections and duration of follow-up was 54±36 months (range: 7-120 months). Eradication of EDG was achieved in seven eyes of which one required a second MTX treatment course to achieve eradication, while clinical resolution with recurrence was observed in two. One treatment failure occurred despite eight weekly injections which slowed but did not halt EDG progression; the patient later requested that treatments be stopped given difficulty to come to follow-ups. Surface epitheliopathy developed in eight patients and was used to titrate MTX treatment. Six patients also developed endothelial failure. CONCLUSION: We report the largest case series of diffuse, sheet-like EDG treated with intraocular MTX with follow-ups up to 10 years. Intraocular MTX may be used effectively to achieve eradication of EDG in cases where surgery is not amenable. However, further recommendations to guide treatment remain warranted.

INTRAVITREAL ANTIVASCULAR ENDOTHELIAL GROWTH FACTOR FOR THE TREATMENT OF CHOROIDAL NEOVASCULARIZATION SECONDARY TO OCULAR HISTOPLASMOSIS: Ten-Year Follow-Up.

PURPOSE: To assess the long-term efficacy of intravitreal antivascular endothelial growth factor injections (IVI), alone or in combination with verteporfin photodynamic therapy (IVI/PDT), for management of choroidal neovascularization secondary to presumed ocular histoplasmosis syndrome (POHS). METHODS: Retrospective, comparative, interventional case series analyzing 82 eyes in 74 patients treated with either IVI or IVI/PDT for presumed ocular histoplasmosis syndrome choroidal neovascularization from January 2006 to January 2021. RESULTS: The average logarithm of the minimum angle of resolution VA in year 5 was 0.40 (20/50) and 0.52 (20/67) for IVI versus IVI/PDT groups, respectively ( P = 0.33), and in year 10 was 0.53 (20/58) and 0.64 (20/86), respectively ( P = 0.50). The average number of annual injections over the first 5 years of follow-up was 3.3 versus 1.7 for IVI versus IVI/PDT groups, respectively ( P < 0.001), and over 10 years was 3.3 versus 1.6, respectively ( P < 0.001). Treatment-free interval of 5 years was reached by 39% versus 60% in IVI versus IVI/PDT groups, respectively ( P = 0.95). CONCLUSION: Our study found both IVI and IVI/PDT to be effective in long-term management of presumed ocular histoplasmosis syndrome choroidal neovascularization, with a fewer number of annual injections and longer treatment-free interval in the combination group. However, given the limitations of a retrospective study, a prospective randomized study is necessary to determine whether the addition of PDT significantly decreases treatment burden.

Pharmacokinetics and Toxicity Evaluation of a PLGA and Chitosan-Based Micro-Implant for Sustained Release of Methotrexate in Rabbit Vitreous.

The present research investigates the pharmacokinetics and toxicity of a chitosan (CS) and poly(lactic-co-glycolic) acid (PLGA)-based methotrexate (MTX) intravitreal micro-implant in normal rabbit eyes. PLGA and CS-based micro-implants containing 400 µg of MTX were surgically inserted in the vitreous of twenty-four New Zealand rabbits using minimally invasive procedures. The PLGA-coated CS-MTX micro-implant and the placebo micro-implant were inserted in the right eye and in the left eye, respectively, of each rabbit. The intravitreal MTX concentration was evaluated on Days 1, 3, 7, 14, 28 and 56. A therapeutic concentration of MTX (0.1-1.0 µM) in the rabbit vitreous was observed for 56 days. The release of MTX in the therapeutic release phase followed first-order kinetics. Histopathologic evaluation on Days 14, 28 and 56 of the enucleated eyes demonstrated no signs of toxicity or any anatomical irregularity in the vitreoretinal domain. Additionally, the micro-implants were stationary at the position of their implantation throughout the duration of the study. The PLGA-coated CS-MTX micro-implant can serve as a potential alternative to the current treatment modality of intravitreal MTX injections based on its performance, thereby avoiding associated complications and the treatment burden of multiple injections.

Outcome of Off-Label AREDS 2 Supplementation for the Treatment of Macular Degeneration in Non-Proliferative Idiopathic Type 2 Macular Telangiectasia.

PURPOSE: To evaluate if off-label Age-Related Eye Disease Study 2 (AREDS2) supplementation prevents visual and anatomical deterioration in non-proliferative Idiopathic Macular Telangiectasia Type 2 (IMT2). PATIENTS AND METHODS: This is a single-center retrospective, comparative study of 82 IMT2 eyes treated with AREDS2 from January 1st, 2013 to January 1st, 2018. The study analysis consisted of a non-comparative arm, which included all AREDS2 eyes, and a comparative arm (27 AREDS2 and 42 untreated eyes) that only included eyes with complete follow-up data. Eyes were evaluated at baseline, 12 and 24 months. Better/worse eye sub-analysis was performed in the comparative study arm. Primary outcomes were best corrected visual acuity (BCVA) and optical coherence tomography (OCT) anatomical characteristics including largest cavitation diameter, central macular thickness (CMT), and length of ellipsoid zone (EZ) loss at 24 months. RESULTS: In the non-comparative arm, AREDS2 eyes showed stable BCVA (0.28 ± 0.18 logMAR at baseline vs 0.26 ± 0.19 logMAR at 24 months; p = 0.35) and OCT anatomical features after 24 months of supplementation. In the comparative arm, BCVA mean difference was greater for untreated eyes at 24 months (-0.09 ± 0.15 vs 0.03 ± 0.11 logMAR; p = <0.001). AREDS2 eyes had decreased cavitary diameter and EZ loss compared to untreated eyes at the study endpoint (p = 0.01 and p = 0.02, respectively). CMT remained stable for both cohorts throughout the study. For better/worse eye analysis, untreated eyes had worse BCVA at 24 months in both better and worse eyes (both p = 0.01). For anatomical outcomes, increases in both EZ loss (p = 0.04) and cavitary diameter (p = 0.001) among untreated eyes were only significant for eyes with worse baseline BCVA. CONCLUSION: Our results suggest that off-label AREDS2 supplementation in non-proliferative IMT2 may prevent anatomical and visual deterioration in a subset of eyes.

Non-invasive evaluation of toxicity in vitreoretinal domain following insertion of sustained release methotrexate micro-implant.

PURPOSE: To evaluate the safety and toxicity profile of a chitosan (CS) and poly(lactic-co-glycolic) acid (PLGA)-based sustained release methotrexate (MTX) intravitreal micro-implant in normal rabbit eyes using non-invasive testing that included electroretinography (ERG), ultrasound biomicroscopy (US), slit-lamp biomicroscopy (SLB), funduscopy, and intraocular pressure (IOP). METHODS: PLGA-coated CS-based micro-implants containing 400 µg of MTX and placebo (without drug) micro-implants were surgically-implanted in the vitreous of the right and the left eyes, respectively, in each of the thirty New Zealand rabbits. ERG, US, SLB, funduscopy, and IOP were assessed in both eyes at pre-determined time points (days: 1, 3, 7, 14, 28 and 56). The safety of micro-implants was assessed by analyzing the ERG data using different statistical models, to quantify and compare the functional integrity of the retina. Further, US, funduscopy, SLB and IOP determined the condition of the retina, the micro-implant and associated intraocular features. RESULTS: Statistical analyses of the ERG data showed unchanged functional integrity of retina between eyes with the PLGA-coated CS-based MTX micro-implant and the placebo micro-implant. US analysis showed that micro-implants were stationary throughout the study. SLB, funduscopy and IOP further confirmed that there were no abnormalities in the intraocular physiology. CONCLUSION: The findings from ERG, US, SLB, funduscopy, and IOP showed no detectable adverse effects caused by our biodegradable micro-implants. These non-invasive techniques appeared to show lack of significant ocular toxicity over time in spite of degradation and changes in morphology of the micro-implants following intraocular implantation.

COMBINED PHACOEMULSIFICATION SURGERY WITH MULTIFOCAL INTRAOCULAR LENS IMPLANTATION AND PARS PLANA VITRECTOMY FOR SYMPTOMATIC VITREOUS OPACITIES.

PURPOSE: To report surgical outcomes of combined vitrectomy for vitreous floaters and phacoemulsification surgery with multifocal intraocular lens implantation. METHODS: Retrospective, interventional, noncomparative case series of five eyes from five patients who underwent same-day combined phacoemulsification surgeries with apodized, diffractive multifocal intraocular lens implantation for cataract and pars plana vitrectomy for symptomatic vitreous opacities, that is, floaters. Primary outcomes were distance and near visual acuities, and resolution of symptoms. Secondary outcomes included intraocular pressure, refractive outcomes, and surgical complications. RESULTS: Mean logarithm of the minimum angle of resolution glare distance visual acuity improved from 0.36 (best-corrected Snellen 20/47) preoperatively to an uncorrected distance visual acuity of 0.05 (Snellen 20/23) at 6 months postoperatively (P = 0.042). All but one patient achieved multifocality with a near visual acuity of J2 or better. All patients noted subjective improvement in symptoms from floaters postoperatively. Mean intraocular pressure remained stable during follow-up. Two eyes ultimately required YAG capsulotomies for symptomatic posterior capsular opacification, one of which additionally received LASEK for refractive correction. CONCLUSION: Multifocality and improvement in symptoms from symptomatic vitreous opacities were observed in this pilot series of carefully selected patients who underwent combined phacovitrectomy with multifocal intraocular lens implantation. A high rate of retinal tears was found in these patients. Appropriate caution should be taken in preoperative assessment and patient selection for the combined procedure.

Reduction in Retinal Thickness Fluctuations After Treatment With Fluocinolone Acetonide Implant for DME: A Post-Hoc Analysis of the USER Study.

BACKGROUND AND OBJECTIVE: Assess fluocinolone acetonide implant (FAc) effects on diabetic macular edema (DME) retinal thickness fluctuations. PATIENTS AND METHODS: A post-hoc chart review of the real-world USER study analyzed patients receiving 0.2 µg/day FAc implant. The percentage of eyes with central subfield thickness (CST) of 300 µm or less were compared pre- and post-FAc implant; mean retinal thickness amplitude (RTA), retinal thickness standard deviation (RTSD), and two case studies were analyzed. RESULTS: One hundred thirty patients (mean age: 69.6 years) presented; CST was available for 120 of 160 treated eyes. Mean RTA decreased significantly post-FAc implant (P < .001) regardless of baseline visual acuity (VA). Correlations with last-observed VA (R2) were: RTA, 0.1197; retinal thickness standard deviation (RTSD), 0.1526; and area under the CST-time curve (AUC CST), 0.0981. After FAc implant, the percentage of eyes with CST of 300 µm or less was significantly greater versus baseline (P < .05). CONCLUSIONS: Retinal thickness fluctuations significantly declined after FAc and correlated with improvement in VA. Both RTSD and RTA measures correlated more closely to last observed VA than AUC CST itself. [Ophthalmic Surg Lasers Imaging Retina. 2020;51:298-306.].

Fluocinolone acetonide (0.19 mg) intravitreal implant reduces treatment burden and improves practice resource utilisation for patients with diabetic macular oedema.

OBJECTIVE: Patients with diabetic macular oedema (DME) are known to have significantly greater medical treatment burden than patients with non-DME. Frequent injections and office visits can have a substantial impact on patient adherence and quality of life. This analysis assesses the impact of the 0.19 mg fluocinolone acetonide (FAc) implant (or injection) on treatment burden and practice resource utilisation in patients with DME. METHODS AND ANALYSIS: This study is a single-centre retrospective chart review of 30 eyes (23 patients) that received a single FAc implant. Data was collected for a 12-month period pre-injection and post-injection of the FAc implant. Primary outcomes included the frequency of injections and ophthalmology office visits. Secondary outcomes included visual acuity (VA), intraocular pressure (IOP) and central subfield thickness (CSFT). RESULTS: The injection frequency significantly decreased from one injection every 2.6 months pre-injection to one injection every 8.8 months post-injection of the FAc implant (p<0.001). Sixty-three percent of the subjects did not require additional injections post-FAc implant. The mean number of ophthalmology office visits significantly decreased from 12.7 visits pre-FAc to 9.3 visits post-FAc implant (p<0.001). The mean VA (p=0.24) and CSFT (p=0.39) showed a mild numerical improvement that was not statistically significant. Thirty-seven percent of the eyes required additional IOP lowering drops. No eyes required incisional glaucoma surgeries. CONCLUSIONS: The FAc implant significantly decreased the treatment burden and improved practice resource utilisation while maintaining or improving VA and CSFT. IOP events were mostly well-controlled with drops and no eyes required incisional glaucoma surgery.

Consolidation of Imaging Modalities Utilizing Digitally Assisted Visualization Systems: The Development of a Surgical Information Handling Cockpit.

The management of vitreoretinal cases is ever-evolving, paralleled by rapid advancements in operative imaging modalities. In this article, we describe an advanced application of digitally assisted vitreoretinal surgery (DAVS) that involves the consolidation of pre-existing ancillary imaging technology into a single same-screen viewing platform. Forty-four eyes of 44 patients were operated using same screen simultaneous viewing of the primary three-dimensional high definition (3DHD) surgical field and simultaneous auxiliary video feed viewing of all currently approved ocular endoscopy (n=12), intraoperative optical coherence tomography (iOCT) units (n=24), or computer feeds from the EHR/image management software (n=8). All surgeries were successful with excellent functional and anatomic outcomes. DAVS facilitated same screen viewing of multiple video/information feeds was notable for improved ergonomics, surgical efficiency, and precision when compared to viewing the surgical field and auxiliary video feeds separately. We describe a new concept for the vitreoretinal operating room - a DAVS-based surgical information handling cockpit - integrating FDA approved ocular endoscopy (n=1), microscope-integrated iOCT units (n=3), and one EHR/Image management solution with the primary surgical field 3DHD feed. We suggest same screen viewing of multiple video and other clinical information feeds is a promising modality that may be considered in the management of patients with surgical vitreoretinal disease and should be purposefully incorporated into future iterations of DAVS technology platforms.

Safety and Efficacy of Subretinally Administered Palucorcel for Geographic Atrophy of Age-Related Macular Degeneration: Phase 2b Study.

PURPOSE: To evaluate safety and successful use of a novel subretinal delivery system and suprachoroidal surgical approach and safety and activity of human umbilical tissue-derived cells (palucorcel) via a novel delivery system in patients with geographic atrophy (GA). DESIGN: Multicenter, open-label phase 2b study. PARTICIPANTS: Participants were 55 to 90 years with GA secondary to age-related macular degeneration (AMD) and best-corrected visual acuity (BCVA) of 20/80 to 20/800. Exclusion criteria included neovascular AMD in the intervention eye, glaucoma with intraocular pressure of 25 mmHg or more, or other significant ophthalmologic conditions. METHODS: Participants received a subretinal injection of palucorcel, 3.0 × 105 cells in 50 µl, using the custom-designed delivery system and surgical procedure. MAIN OUTCOME MEASURES: Safety assessments included treatment-emergent adverse events (AEs), immunologic assessments, and ophthalmologic evaluations. Efficacy was evaluated as change in mean number of BCVA letters from baseline, proportion of participants gaining 15 BCVA letters or more, and growth rate of GA lesions at 12 months. RESULTS: Surgery and palucorcel administration were performed in 21 participants at 8 sites by 8 different surgeons. At baseline, median total area of GA was 13.4 mm2 and median BCVA was 43 letters in the intervention eye. Eye-related AEs occurred in 76% of participants (16/21), including conjunctival hemorrhage (n = 5), retinal hemorrhage (n = 4), and vitreous floaters (n = 4). Most AEs were mild and resolved within 1 month. No serious AEs, no retinal detachment or perforation, and no significant changes in intraocular pressure occurred. At month 12, mean change in BCVA from baseline was -5.9 letters correct (standard deviation, 13.0 letters correct) in the intervention eye and -3.7 letters correct (standard deviation, 9.0 letters correct) in the fellow eye. No participants showed improvement of 15 letters or more in the intervention eye, and 3 participants lost more than 15 letters by month 1. No apparent effect of treatment was observed. CONCLUSIONS: Palucorcel was delivered successfully to the targeted subretinal site using a novel delivery system and suprachoroidal approach for most participants; however, improvement in GA area, retardation of growth, or visual acuity were not demonstrated.

Short-term outcomes of combined pars plana vitrectomy for epiretinal membrane and phacoemulsification surgery with multifocal intraocular lens implantation.

PURPOSE: The purpose of this study was to evaluate the functional and anatomical outcomes of combined phacovitrectomy with multifocal intraocular lens (mfIOL) implantation. METHODS: Retrospective, interventional, non-comparative case series of six eyes that received a combined phacoemulsification surgery with apodized, diffractive mfIOL implantation for cataract and pars plana vitrectomy (PPV) with membrane peeling for epiretinal membrane (ERM). Outcome measures included distance and near visual acuities (DVA and NVA), central macular thickness (CMT), intraocular pressure (IOP), and disruption of external limiting membrane (ELM) or inner-segment outer-segment (IS/OS) junction. RESULTS: Mean logMAR glare DVA improved from 0.40 (Snellen 20/50) preoperatively to a mean uncorrected DVA of 0.038 (Snellen 20/22) (P=0.004) at 6 months after surgery. All eyes achieved NVA of J2 or better by 12 months postoperatively. Median CMT improved by 10 µm and mean IOP increased by 1 mmHg at 12 months postoperatively. Percentage of patients with ELM or IS/OS disruptions decreased from 66.7% to 33.3%. Two eyes demonstrated residual metamorphopsia on Amsler grid testing postoperatively. Postoperatively, four eyes required laser capsulotomy and one required LASEK for refractive correction. CONCLUSION: Combined phacovitrectomy, membrane peeling, and mfIOL implantation improved VA in patients with idiopathic ERM. Multifocality was achieved, but final visual outcome was delayed due to posterior capsular opacification and macular healing.

INTRAOPERATIVE OCULAR MANOMETRY IN SILICONE OIL-FILLED EYES WITH A BOSTON TYPE 1 KERATOPROSTHESIS.

PURPOSE: To demonstrate a novel technique to measure the intraocular pressure in silicone oil (SO)-filled eyes with Boston Type 1 keratoprosthesis (KPro) during intraocular surgery. METHODS: In this retrospective case series, an ocular manometer that is predicated on a continuous fluid column between a pressure sensor and interior of the eye was designed and used to directly measure intraocular pressure during intraocular surgery in SO-filled eyes with KPro. RESULTS: Six eyes of six patients were included in the study. The indications for SO injection with ocular manometry were hypotony in five patients, and endophthalmitis and complex retinal detachment with proliferative vitreoretinopathy in one patient. All patients had a successful reinflation of their globes without any evidence of SO underfill, without evidence of SO overfill, and without progression of glaucomatous optic neuropathy. Visual acuity increased in five eyes and was maintained in one eye. CONCLUSION: Intraoperative ocular manometry is a safe and effective technique in determining intraocular pressure in SO-filled eyes with KPro.

The USER Study: A Chart Review of Patients Receiving a 0.2 µg/day Fluocinolone Acetonide Implant for Diabetic Macular Edema.

INTRODUCTION: To determine anatomical, functional, and intraocular pressure (IOP) responses to diabetic macular edema (DME) treatments pre- and post-0.2 µg/day fluocinolone acetonide (FAc) implant administration compared with baseline and the preceding 3 years. METHODS: This was a retrospective, chart review, cohort study in four U.S. centers. Patients received the 0.2 µg/day FAc implant for the treatment of DME in at least one eye before January 1, 2016. DME treatments administered up to 36 months pre-FAc implant and up to 24 months post-FAc implant were recorded, and treatment frequency was calculated. Visual acuity (VA) was assessed using a Snellen eye chart and converted to early treatment diabetic retinopathy study (ETDRS) letters, and central subfield thickness (CST) was measured using optical coherence tomography (OCT). Treatment frequency, mean VA, mean CST, percentage of patients with CST of ≤ 300 µm, mean IOP, IOP events, and IOP treatments pre- and post-FAc implant administration were measured. Positive and negative predictive values for the IOP response to prior steroid therapy were also determined. RESULTS: In total, 160 eyes of 130 patients were studied. VA was maintained at pre-FAc levels from baseline to month 24, despite a significant reduction in treatment frequency from one treatment every 2.9 months pre-FAc implant to one treatment every 14.3 months post-FAc implant. Patients with better baseline VA required fewer DME treatments post-FAc than did patients with worse baseline VA. The majority of patients did not require additional DME treatment during the post-FAc follow-up period. A significant reduction in CST and an increase in the percentage of patients with CST of ≤ 300 µm were seen up to month 21 post-FAc implant. Pre-FAc implant IOP was maintained during the post-FAc implant period; increased IOP with prior steroid therapy was found to be highly predictive of increased IOP post-FAc implant. CONCLUSION: The results of this study confirm the positive safety and efficacy profile of the FAc implant and demonstrate for the first time the effectiveness of the U.S. label indication of FAc in reducing the incidence of post-treatment pressure elevation. The FAc implant significantly reduced treatment burden in the overall population without significantly increasing the risk of steroid-induced pressure elevation. FUNDING: Alimera Sciences.

Association of Mentor-to-Program Contact and Applicant Rank Disclosure With Vitreoretinal Fellowship Applicant's Final Match Outcome in 2016 and 2017.

Importance: Communication between applicants, mentors, and training programs is common before the residency and fellowship match. Few studies have examined the association of prematch communication on final match outcomes. Objectives: To report various characteristics of the vitreoretinal surgery fellowship match and to examine the association of mentor-to-program communication and applicant disclosure of their number 1 ranking with the probability of matching number 1. Design, Setting, and Participants: In this cross-sectional study of the 2016 and 2017 vitreoretinal surgery fellowship matches, an online survey examined (1) number of applications submitted, (2) number of programs ranked, (3) rank order of final match, (4) total application and interview-related costs, (5) mentor-to-program contact, (6) applicant disclosure of number 1 ranking, and (7) mentor disclosure of number 1 ranking. A link to an anonymous online survey was sent to 198 matched fellows (105 fellows from the 2016 match and 93 from the 2017 match). Main Outcomes and Measures: Survey responses regarding the vitreoretinal surgery fellowship application process. Results: The survey was sent to 198 matched fellowship applicants, and 152 (77%) completed the survey. Of the 105 matched applicants in 2016, 21 (20%) were women. Of the 93 matched applicants in 2017, 24 (26%) were women. Matched applicants applied to a mean (SD) of 34 (17) programs (range, 1-85) and ranked a mean (SD) of 12 (4) programs (range, 1-27). Of 152 applicants, 66 (43%) matched at their number 1 ranked program, 23 (15%) matched number 2, and 21 (14%) matched number 3. The mean (SD) total cost was $5500 ($2776) (range, $500-$13 500). Two-sided χ2 testing found no association (odds ratio, 0.70; 95% CI, 0.34-1.4; P = .33) between mentor-to-program contact and the probability of applicants matching at their number 1 ranked program. Matched applicants who revealed their number 1 ranking either personally or via a mentor matched at a program ranked lower (more desirable) on their rank list (mean match ranking, 2.8) compared with those who did not reveal their number 1 ranking (mean match ranking, 4.2; 95% CI, 0.2-2.5; P = .01). Applicant disclosure of their intention to rank a program number 1, either personally or via a mentor, was associated with matching number 1 (odds ratio, 2.6; range, 1.1-6.0; P = .03). Conclusions and Relevance: Vitreoretinal fellowship applicants who disclosed their number 1 ranking, either personally or via a mentor, were associated with improved match outcomes compared with their cohorts who did not make such disclosures.