Baseline Ocular Characteristics Research Articles

Prediction of MIGS outcomes on second eyes using first eyes' response.

To evaluate how well outcomes following cataract extraction and microinvasive glaucoma surgery in one eye predict outcomes in sequential second eye. Retrospective study of 78 patients who underwent cataract extraction and microinvasive glaucoma surgery in both eyes. Linear regressions using Pearson correlation coefficients were used to evaluate correlations in intraocular pressure and glaucoma medication change between eyes. Multivariable logistic regression models were used to evaluate the associations between first-eye variables and the likelihood of second-eye surgical success at 6 months. Surgical success was defined as meeting target intraocular pressure without additional medications compared to baseline or secondary surgical interventions. Baseline ocular characteristics were comparable between fellow eyes, with the majority having mild glaucoma. Intraocular pressure changes between fellow eyes at 6 months were modestly correlated between eyes (R = 0.48; P < .001). Changes in glaucoma medications were strongly correlated between eyes at all time points, and month 6 demonstrated the most significant correlation (R = 0.80; P < .001). First and second eye cohorts achieved 82% and 83% surgical success. Multivariate analysis for predictive factors of successful second eye surgery showed patients with successful first eye surgery at 6 months were significantly more likely to have successful second eye surgery (odds ratio, 20.67; P < .001). Reductions in intraocular pressure and glaucoma medications at 6 months following surgery in first eyes are correlated to second eye reductions. Successful surgical outcomes at 6 months following first eye surgeries are strongly associated with successful sequential second eye outcomes.

Hemorrhagic Complications Following Trabecular Bypass Microstent Surgery in the Setting of Antithrombotic Therapy.

In this retrospective study, the use of chronic antithrombotic therapy (ATT) did not increase the risk of hemorrhagic complications after trabecular bypass microstent surgery and phacoemulsification. Stent type and female sex were associated with hyphema. To report the incidence of hemorrhagic complications after trabecular bypass microstent surgery and phacoemulsification with and without (ATT). Retrospective case series on glaucoma patients on chronic ATT who underwent trabecular bypass microstent surgery (iStent, iStent inject, and Hydrus) combined with phacoemulsification between 2013 and 2019 with ≥3-month follow-up. The primary outcome measure was the incidence of hemorrhagic complications within a 3-month postoperative period. Generalized estimating equations were created to account for inter-eye correlation and logistic regression analysis was performed to identify factors predictive of hemorrhagic complications. Of 333 patients (435 eyes), 161 patients (211 eyes) were on ATT and 172 patients (224 eyes) were not on ATT; both groups were similar in age and baseline ocular characteristics. The only hemorrhagic complication was hyphema, which occurred in 84 (19.3%) eyes (41 ATT, 43 non-ATT eyes; P = 1.00). Onset was at postoperative day 1 in 98.8% of eyes, with a duration of 1 week in 73.8% of eyes, without difference between ATT and non-ATT groups. Hyphema was most common with Hydrus microstent (36.4%) versus iStent (19.9%) and iStent inject (8.5%) ( P = 0.003). In the multivariate model, the female sex was a predictor of hyphema [hazard ratio (HR) = 2.062; P = 0.009], iStent inject was protective against hyphema (HR = 0.379; P = 0.033), whereas Hydrus did not reach statistical significance (HR = 2.007; P = 0.081). Age, systemic comorbidities, ATT use, and baseline ocular characteristics were not significant predictors. Hemorrhagic complications after trabecular bypass microstent surgery were limited to transient hyphema and were not associated with chronic ATT use. Stent type and female sex were associated with hyphema.

Subretinal Fluid Resolution and Visual Acuity in Patients with Neovascular Age-Related Macular Degeneration: A HARBOR Post Hoc Analysis

To determine the effect of subretinal fluid (SRF) resolution on visual acuity in patients with neovascular age-related macular degeneration (nAMD) from the HARBOR trial. Post hoc analysis of the HARBOR trial (a phase 3, double-masked, randomized, active treatment-controlled trial of ranibizumab conducted between July 2009 and August 2012 [NCT00891735]) was carried out from January 2020 to July2021. Treatment-naive patients with nAMD and active subfoveal choroidal neovascularization (N= 1097). Multiple intervention arms were pooled for this analysis if SRF was present at baseline and intraretinal fluid/SRF resolved during the study, based on spectral-domain OCT (n= 349). Three monthly loading doses followed by intravitreal injections of 0.5-mg or 2.0-mg ranibizumab were administered monthly or pro re nata over 24 months. Mean change in ETDRS best-corrected visual acuity (BCVA) between the month before SRF resolution and the month of SRF resolution detection. Visual outcomes at months 12 and 24 were analyzed in eyes without SRF recurrence after SRF resolution. The proportion of patients who lost ≤ 4 letters were considered as vision gainers/maintainers and those who lost ≥ 5 were considered as vision losers. Of 349 patients, 32 patients (9%) lost ≥ 5 ETDRS letters (mean [95% confidence interval (CI)], -9.9 letters [-12.0,-7.9]) and 317 (91%) of the eyes gained/maintained BCVA (mean, 6.1 letters [95% CI, 5.3, 6.8]) between the month before SRF resolution and the month of SRF resolution. There were no differences in baseline ocular characteristics between patient groups. Among eyes without SRF recurrence after SRF resolution (64%; 224/349), eyes that lost ≥ 5 ETDRS letters compared with those that gained/maintained letters at the time of SRF resolution had reduced visual outcome gains from baseline to month 12 (1.4 vs. 12.9 letters) and month 24 (0.0 vs. 12.6 letters). A greater proportion of ranibizumab-treated eyes with nAMD gained/maintained visual acuity at SRF resolution. Approximately 9% of eyes lost vision during SRF resolution; these eyes had reduced final visual acuity gains at 12 and 24 months. Further analyses are warranted to investigate potential underlying factors and discuss the treatment implications if confirmed.

Retinal pigment epithelial atrophy after anti-vascular endothelial growth factor therapy for polypoidal choroidal vasculopathy

Background/aimsTo describe the risk factors for the development of retinal pigment epithelial (RPE) atrophy following intravitreal anti-vascular endothelial growth factor (VEGF) injection treatment for polypoidal choroidal vasculopathy (PCV).MethodsWe retrospectively included...

Baseline Ocular Characteristics of Patients Undergoing Initiation of Anti-Vascular Endothelial Growth Factor Therapy for Diabetic Macular Edema.

Patients with diabetic macular edema (DME) have variable anatomic and visual responses to anti-vascular endothelial growth (VEGF) treatments based on their presenting visual acuity (VA). The aim of study is to report the baseline ocular and imaging characteristics of patients presenting with DME who were treatment-naïve and who initiated anti-VEGF in routine clinical practice. Single-center, cross-sectional study of 638 patients. Subjects were divided into two VA groups: Early Treatment Diabetic Retinopathy Study (ETDRS) less than 70 and ETDRS greater than 70 and ocular variables were compared between groups. Average central subfield thickness (CST) was 363.5 μm, cube volume was 11.7 mm3, and cube average thickness (CAT) was 326.1 μm. Additionally, 21.5% had subretinal fluid (SRF), and 50.5% had hard exudates on presentation. Eyes with ETDRS less than 70 had greater CAT (338.5 μm3 vs. 313.2 μm3; P < .001), greater cube volume (12.2 mm3 vs. 11.3 mm3; P < .001), greater CST (383.5 μm vs. 350.0 μm; P < .001), and SRF (25.5% vs. 17.3%; P = .012). Furthermore, 7.64% had glaucoma, 1.3% had dry age-related macular degeneration, 4.5% of patients were vitrectomized, and 28.7% were pseudophakic. Regarding diabetic stage, 37% had proliferative diabetic retinopathy (PDR) and 63% presented with nonproliferative diabetic retinopathy. Patients presenting with ETDRS less than 70 were more likely to have a history of vitrectomy (7.1% vs. 1.9%, P = .002) and presence of PDR (42.3% vs. 31.4%, P = .004). The results describe a population of patients from a routine clinical practice not entirely represented in clinical trials, with key differences in ocular characteristics seen between VA groups. [Ophthalmic Surg Lasers Imaging Retina. 2019;50:69-75.].

Ocriplasmin Treatment Leads to Symptomatic Vitreomacular Adhesion/Vitreomacular Traction Resolution in the Real-World Setting: The Phase IV ORBIT Study

To evaluate clinical outcomes and safety up to 12 months after ocriplasmin injection for the treatment of patients with symptomatic vitreomacular adhesion (VMA)/vitreomacular traction (VMT) in a real-world setting. The Phase IV Ocriplasmin Research to Better Inform Treatment (ORBIT) trial (NCT02079883) was a Phase IV multicenter, prospective, observational study. Patients aged ≥18 years with symptomatic VMA/VMT treated with ocriplasmin. Patients received a single 0.125 mg intravitreal injection of ocriplasmin. All assessments and treatment decisions were at the discretion of the treating physician. Spectral-domain OCT (SD-OCT) images were analyzed by an independent central reading center (CRC). All enrolled patients were included in demographic, baseline characteristics, and safety analyses. Patients with symptomatic VMA/VMT at baseline determined by CRC were included in baseline ocular characteristics and efficacy analyses. Clinical outcomes were measured up to 12 months and included resolution of symptomatic VMA, closure of full-thickness macular hole (FTMH), mean change from baseline in best-corrected visual acuity (BCVA), incidence of vitrectomy, and time to first vitrectomy. Safety outcomes included the incidence and timing of onset of adverse drug reactions (ADRs). Of the 539 patients enrolled, 480 were determined to have symptomatic VMA/VMT at baseline post-CRC assessment. After treatment with ocriplasmin, the rate of VMA/VMT resolution was 45.8% (95% confidence interval [CI], 41.3-50.4) at month 1 and 59% (95% CI, 54.4-63.4) at months 10 to 12. The rate of FTMH closure was 30.5% (95% CI, 22.4-39.7) at month 1 and 32.2% (95% CI, 23.9-41.4) at months 10 to 12. Mean (standard deviation) change from baseline in BCVA was 1.5 (11.19) letters at month 1 and 5.2 (13.60) letters at months 10 to 12. Vitrectomy was performed in 28.5% of patients, with a median time to vitrectomy of 63 days. Adverse drug reactions were reported by 30.6% of patients; 5.2% experienced a serious ADR. Results from the ORBIT study demonstrate that treatment with ocriplasmin is effective and well tolerated in patients with symptomatic VMA/VMT in a real-world setting. The percentage of patients with VMA/VMT resolution at month 1 was higher than previously reported in well-controlled clinical trials. No new safety signals were identified.

Baerveldt shunt surgery versus combined Baerveldt shunt and phacoemulsification: a prospective comparative study

AimTo examine the efficacy and safety of Baerveldt tube (BT) implantation compared with combined phacoemulsification and Baerveldt tube (PBT) implantation in patients with refractory glaucoma.MethodsSeventy-six eyes of 76 patients were...

Subthreshold Nanosecond Laser Intervention in Intermediate Age-Related Macular Degeneration: Study Design and Baseline Characteristics of the Laser in Early Stages of Age-Related Macular Degeneration Study (Report Number 1)

The Laser Intervention in Early Stages of Age-Related Macular Degeneration (LEAD) study is an investigation of the safety and efficacy of subthreshold nanosecond laser treatment to slow the progression of intermediate age-related macular degeneration (AMD). This report presents the novel study design and baseline characteristics. Multicenter, double-masked, randomized controlled, medical device feasibility clinical trial. Persons with bilateral drusen >125 μm within 1500 μm of the fovea, monocular best-corrected visual acuity (BCVA) ≥20/40, and microperimetric retinal sensitivity of <25 decibels (dB) in at least 1 location within central 6° in 1 eye. Signs of late AMD; choroidal neovascularization or geographic atrophy, or anatomic end points defined on multimodal imaging (MMI) as fundus autofluorescence-defined atrophy, spectral-domain OCT (SD-OCT)-defined atrophy, or nascent GA excluded participation. Participants were randomized to nanosecond or sham laser treatment. Twelve laser or sham spots are applied to the macular region of the study eye. Participants are reviewed in visits every 6 months with functional testing and MMI for 36 months and are re-treated at each visit (until 30 months) if an end point is not reached in the study eye. Progression to late AMD or MMI-defined anatomic end points in the study eye. A total of 292 participants across 6 centers were enrolled, with 145 participants randomized to arm 1 and 147 participants randomized to arm 2. Population characteristics at baseline were as follows: median age 70 years, 73% female, 90% Anglo-Saxon, and 3% current smokers. Baseline ocular characteristics of the study eyes were BCVA of 83 letters (20/25); low luminance visual acuity (LLVA) of 68 letters (20/50); hyperpigmentation, 33%; reticular pseudodrusen, 23%; square root drusen area (SD-OCT), 0.77mm; square root drusen area (color photographs), 0.92 mm; cube root drusen volume (SD-OCT), 0.26 mm; average retinal sensitivity, 26 dB; and worst point retinal sensitivity, 20 dB. Only lutein supplement use was significantly different between treatment arms. The LEAD study uses novel inclusion/exclusion criteria and end points in an attempt to optimize our study design. Risk characteristics for progression to study end points are equally distributed between treatment arms.

Outcomes of Resident-Performed Descemet's Stripping Automated Endothelial Keratoplasty

Purpose This article aimed to evaluate outcomes of resident-performed Descemet's stripping automated endothelial keratoplasty (DSAEK). Methods This is a case series of patients who underwent DSAEK performed by PGY-4 ophthalmology residents at Lyndon B. Johnson Hospital from January 2013 to August 2016 staffed by a fellowship-trained cornea specialist. Patients with less than 1 month of follow-up were excluded. Demographics, baseline ocular characteristics, and intraoperative data were recorded. Vision and graft status were recorded at 1 week, 1 month, 3 months, and the last follow-up visits. Surgical failure was defined as graft detachment within 1 week of surgery and/or primary graft failure within 3 months of surgery. Results Eighteen eyes of 18 patients who followed up for 14.9 months (±12.9) were included. Mean age of patients was 60.9 years (±13.2). Indications for DSAEK included pseudophakic bullous keratopathy (10), Fuchs endothelial dystrophy (4), and other causes of endothelial dysfunction (4). Eleven (61%) eyes had prior ocular surgery, and 7 (39%) had prior glaucoma surgery. There were no postoperative graft detachments and two (11%) primary graft failures. There was one primary graft failure in a glaucoma patient. Of the 16 graft successes, logMAR visual acuity improved by 0.46 logMAR (±0.73) from baseline. Conclusion With appropriate staffing by an experienced cornea surgeon, DSAEK with residents as the primary surgeons is a safe and effective procedure with reasonably good outcomes.

Demographic characteristics and visual status of patients undergoing cataract surgery at a tertiary hospital in Kano, Nigeria

Objective/Purpose:To describe the demographic and baseline ocular characteristics, prevalence of blindness and visual impairment among patients undergoing extracapsular cataract extraction for age related cataract at the study hospital over a one year period.Materials/Patients:All consecutive patients aged 40 years and above identified with age related cataract in one or both eyes who voluntarily agree to participate were included.Methods:The study adhered to the tenets of the Helsinki declaration. Written informed consent was obtained from all eligible patients. All patients underwent basic eye examination by the ophthalmologist. Visual impairment was determined for each eye according to the standard WHO categorizations. Information obtained also included age, sex and history of previous cataract surgery. Data were recorded in manual tally sheets and on modified computer Cataract Surgery Record forms. Analyses were done using SPSS (version 16, SPSS Inc., Chicago, USA).Results:The participation rate was 91.2%. There were 495 eyes of 487 consecutive patients. This include 212 males and 275 females (M:F, 1:1.3). The age range was 40 to 99 years with a mean age of 62.76 ± 10.49 years (61.35 ± 9.75 years in men and 63.85±10.9 years in females). Most of the patients (n = 451; 92.6%, 95% CI: 89.9-94.6%) were aged 50 years and above. Sixty patients (12.3%, 95% CI: 9.6-15.5%) had cataract in both eyes, 427 (87.7%, 95% CI: 84.5-90.3%) were in one eye. Among these, preoperatively 16 (3.3%, 95% CI: 2.0-5.3%) had aphakia, 21 (4.3%, 95% CI: 2.8-6.5%) had uniocular pseudophakia. About 63.2% (95% CI: 58.9-67.4%) of patients had normal vision in the better eye (presenting VA ≥6/18). Overall 9.5% (95% CI: 7.3-12.7%) were bilaterally blind. About 96.8% of eyes (95% CI: 94.5-98.0%) undergoing cataract surgery were blind (presenting VA< 3/60).Conclusion:The study highlights preponderance of females and high incidence of blinding cataract. Education and early disease awareness may play an important role in these patients and could improve cataract surgical services in our hospital.

Epimacular Brachytherapy for Previously Treated Neovascular Age-Related Macular Degeneration (MERLOT): A Phase 3 Randomized Controlled Trial

To assess the safety and efficacy of epimacular brachytherapy (EMB) for patients with chronic, active, neovascular age-related macular degeneration (AMD). Phase 3 randomized controlled trial. Patients (n= 363) with neovascular AMD already receiving intravitreal ranibizumab injections. Either pars plana vitrectomy with 24-gray EMB and ongoing pro re nata (PRN) ranibizumab (n=224) or ongoing PRN ranibizumab monotherapy (n= 119). The coprimary outcomes, at 12 months, were the number of PRN ranibizumab injections and Early Treatment of Diabetic Retinopathy Study (ETDRS) best-corrected visual acuity (VA). Secondary outcomes included the proportion of participants losing fewer than 15 ETDRS letters, angiographic total lesion size, choroidal neovascularization (CNV) size, and optical coherence tomography (OCT) foveal thickness. A predefined subgroup analysis tested the influence of baseline ocular characteristics on the response to EMB. The mean number of PRN ranibizumab injections was 4.8 in the EMB arm and 4.1 in the ranibizumab monotherapy arm (P= 0.068). The mean VA change was-4.8 letters in the EMB arm and-0.9 letters in the ranibizumab arm (95% confidence interval of difference between groups,-6.6 to-1.8 letters). The proportion of participants losing fewer than 15 letters was 84% in the EMB arm and 92% in the ranibizumab arm (P= 0.007). In the EMB arm, the mean total lesion size increased by 1.2 mm(2) versus 0.4 mm(2) in the ranibizumab arm (P= 0.27). The CNV size decreased by 0.5 mm(2) in the EMB arm and by 1.3 mm(2) in the ranibizumab arm (P= 0.27). The OCT foveal thickness decreased by 1.0 μm in the EMB arm and by 15.7 μm in the ranibizumab arm (P= 0.43). Most subgroups favored ranibizumab monotherapy, some significantly so. One participant showed retinal vascular abnormality attributed to radiation, but otherwise safety was acceptable. These results do not support the use of EMB for chronic, active, neovascular AMD. Safety isacceptable out to 12 months, but radiation retinopathy can occur later, so further follow-up is planned.

Improved efficacy of ocriplasmin for vitreomacular traction release and transient changes in optic disk morphology.

To determine the efficacy and safety of ocriplasmin for vitreomacular traction (VMT) resolution and to study changes in optic disk and peripapillary region. Retrospective, single-center, observational case series. In 38 eyes with VMT (10 with concomitant full-thickness macular hole), determined by optical coherence tomography, a single intravitreal injection of ocriplasmin was administered. Baseline ocular characteristics included the presence/absence of epiretinal membrane, lens status, and vitreomacular adhesion size. Spectral domain optical coherence tomography and Heidelberg retinal tomography were performed at baseline and follow-up visits. A total of 71.1% of eyes treated with ocriplasmin had VMT resolution, improving to 83.9% after applying MIVI-TRUST selection criteria. A total of 90% of eyes with full-thickness macular hole showed VMT resolution, with 40% of those achieving full-thickness macular hole closure. Subretinal fluid in the macular region was observed in 36.8% of eyes 1 day after injection, and all cleared spontaneously by Day 42. A significant difference was observed in cup/disk area ratio between patients who achieved VMT resolution and patients who did not. Careful patient selection improves ocriplasmin efficacy. Transient optic disk morphology changes such as decreased cup/disk area ratio may occur in patients without VMT resolution.

Ocriplasmin for the Treatment of Symptomatic Vitreomacular Adhesion/Traction

Ocriplasmin has recently been introduced as a new treatment option for patients with symptomatic vitreomacular adhesion/vitreomacular traction (VMA/VMT). Understanding its potential as well as its limitations is crucial as it becomes an additional tool in the management of these diseases. In this article the overall efficacy and safety of ocriplasmin are reviewed, focusing on the results from the phase III clinical trials as well as recently published case reports and postmarketing data analysis. Efficacy data from ocriplasmin use in a clinical setting support the subanalysis of the phase III clinical trial data. This analysis demonstrated that certain baseline ocular characteristics, namely focal VMA, and absence of epiretinal membrane, are predictive of VMA resolution. Safety findings show that the overall percentage of patients experiencing adverse events during the clinical trial program was low in ocriplasmin-treated patients. Postmarketing surveillance data corroborate findings from the phase III trials, and provide additional insights into the characterization of the safety profile of this new treatment option.

Ocriplasmin for the Treatment of Symptomatic Vitreomacular Adhesion/Traction

Ocriplasmin has recently been introduced as a new treatment option for patients with symptomatic vitreomacular adhesion/vitreomacular traction (VMA/VMT). Understanding its potential as well as its limitations is crucial as it becomes an additional tool in the management of these diseases. In this article the overall efficacy and safety of ocriplasmin are reviewed, focusing on the results from the phase III clinical trials as well as recently published case reports and postmarketing data analysis. Efficacy data from ocriplasmin use in a clinical setting support the subanalysis of the phase III clinical trial data. This analysis demonstrated that certain baseline ocular characteristics, namely focal VMA, and absence of epiretinal membrane, are predictive of VMA resolution. Safety findings show that the overall percentage of patients experiencing adverse events during the clinical trial program was low in ocriplasmin-treated patients. Postmarketing surveillance data corroborate findings from the phase III trials, and provide additional insights into the characterization of the safety profile of this new treatment option.

Risk Factors for Geographic Atrophy After Intravitreal Ranibizumab Injections for Retinal Angiomatous Proliferation

To describe the risk factors for the development of geographic atrophy (GA) following intravitreal ranibizumab injection treatment for retinal angiomatous proliferation (RAP). Retrospective interventional series. Forty-three eyes (38 South Korean patients) from patients being treated for naïve RAP with intravitreal ranibizumab injection were included in this study. All patients were treated with an initial series of 3 monthly loading injections, followed by further injections as required. Baseline ocular characteristics and lesion features assessed using fluorescein angiography (FA), indocyanine angiography (ICGA), and spectral-domain optical coherence tomography (SD OCT) were evaluated as potential risk factors for GA through 2 years of follow-up. At 2 years follow-up, GA had developed in 16 of 43 eyes (37.2%). The mean number of ranibizumab injections was 7.52 ± 2.11. Using multiple logistic regression, thinning of the subfoveal choroid at baseline (odds ratio [OR], 0.955; 95% confidence interval [CI], 0.929-0.982; P = .002), presence of reticular pseudodrusen (OR, 1.092; 95% CI, 1.017-1.485; P = .039), and presence of GA in the fellow eye at baseline (OR, 1.433; 95% CI, 1.061-1.935; P = .025) were identified as significant risk factors for GA development. GA developed in 37.2% of eyes with RAP during the 24 months following intravitreal ranibizumab injections. Subfoveal choroidal thinning at baseline, the presence of reticular pseudodrusen, and the presence of GA in the fellow eye at baseline were associated with increased risk of GA development after treatment.

Sustained Delivery Fluocinolone Acetonide Vitreous Implants: Long-Term Benefit in Patients with Chronic Diabetic Macular Edema

To present the safety and efficacy of intravitreal implants releasing 0.2 μg/day fluocinolone acetonide (FAc) in patients with chronic versus nonchronic diabetic macular edema (DME). To assess ocular characteristics, anatomic changes, and re-treatment and ancillary therapies that may explain the differential treatment effect seen with intravitreal implants releasing FAc 0.2 μg/day in patients with chronic and nonchronic DME. An overall benefit-to-risk assessment for the FAc 0.2-μg/day and FAc 0.5-μg/day doses has been reported previously. Preplanned subgroup analysis of chronic (duration of diagnosis, ≥3 years) and nonchronic (duration of diagnosis, <3 years) DME in patients from 2 randomized, sham injection-controlled, double-masked, multicenter clinical trials. Patients with persistent DME despite 1 or more macular laser treatment were randomized 1:2:2 to sham injection (n = 185), FAc 0.2 μg/day (n = 375), or FAc 0.5 μg/day (n = 393). Patients received study drug or sham injection and after 6 weeks were eligible for rescue laser. Based on re-treatment criteria, additional masked study drug could be given after 1 year. Percentage of patients with improvement of 15 letters or more from baseline. Secondary outcomes included other parameters of visual function and foveal thickness. At month 36, the difference between FAc 0.2 μg/day and sham control in the percentage of patients who gained 15 letters or more was significantly greater in chronic DME patients (FAc 0.2 μg/day, 34.0% vs. sham, 13.4%; P<0.001), compared with patients with nonchronic DME (FAc 0.2 μg/day, 22.3% vs. sham, 27.8%; P = 0.275). The greater response in patients with chronic DME was not associated with baseline ocular characteristics, changes in anatomic features, or differences in re-treatment or ancillary therapies. The ocular adverse event profile for FAc 0.2 μg/day was similar regardless of DME duration. This is the first published analysis correlating duration of diagnosis of DME with treatment effect. In patients with chronic DME, FAc 0.2 μg/day provides substantial visual benefit for up to 3 years and would provide an option for patients who do not respond to other therapy.

Risk of Geographic Atrophy in the Comparison of Age-related Macular Degeneration Treatments Trials

To describe risk factors for geographic atrophy (GA) in the Comparison of Age-related Macular Degeneration Treatments Trials (CATT). Cohort within a randomized clinical trial. We analyzed 1024 CATT patients with no GA visible on color fundus photographs (CFPs) and/or fluorescein angiograms (FAs) at enrollment. Eyes were assigned to ranibizumab (0.5 mg) or bevacizumab (1.25 mg) treatment and to a 2-year monthly or pro re nata (PRN) injection regimen, or monthly injections for 1 year and PRN for 1 year. Demographic, genetic, and baseline ocular characteristics and lesion features of CFP/FA and optical coherence tomography (OCT) were evaluated as risk factors for GA through 2 years of follow-up. Time-dependent Cox proportional hazard models were used to estimate adjusted hazard ratios (aHRs). Development of GA. By 2 years, GA developed in 187 of 1024 patients (18.3%). Baseline risk factors for GA development included baseline visual acuity (VA) ≤20/200 (aHR, 2.65; 95% confidence interval [CI], 1.43-4.93), retinal angiomatous proliferation (RAP; aHR, 1.69; 95% CI, 1.16-2.47), GA in the fellow eye (aHR, 2.07; 95% CI, 1.40-3.08), and intraretinal fluid at the foveal center (aHR, 2.10; 95% CI, 1.34-3.31). Baseline factors associated with lower risk for GA development included blocked fluorescence (aHR, 0.49; 95% CI, 0.29-0.82), OCT measurements of subretinal fluid thickness of >25 μ (aHR, 0.52; 95% CI, 0.35-0.78), subretinal tissue complex thickness of >275 compared with ≤75 μ (aHR, 0.31; 95% CI, 0.19-0.50), and vitreomacular attachment (aHR, 0.55; 95% CI, 0.31-0.97). Ranibizumab compared with bevacizumab had a higher risk (aHR, 1.43; 95% CI, 1.06-1.93), and monthly dosing had a higher risk (aHR, 1.59; 95% CI, 1.17-2.16) than PRN dosing. There were no strong associations between development of GA and the presence of risk alleles for CFH, ARMS 2, HTRA1, C3, or TLR3. Approximately one fifth of CATT patients developed GA within 2 years of treatment. Independent baseline risk factors included poor VA, RAP, foveal intraretinal fluid, monthly dosing, and treatment withranibizumab. Anti-vascular endothelial growth factor therapy may have a role in the development of GA.

Eye injuries in a terrorist bombing : Dhahran, Saudi Arabia, june 25, 1996

Objective We report the experience of our institution in the evaluation and care of multiple simultaneous ocular trauma patients after a terrorist bomb attack on a United States military base in Saudi Arabia. Design Retrospective, noncomparative small case series. Participants Three patients who received severe ocular injuries after a terrorist bombing. Intervention All patients underwent surgical repair of the injuries that were inflicted as a result of the terrorist bombing. Main outcome measures Baseline ocular characteristics, intraoperative findings, surgical procedures, and final (3 years after injury) anatomic and visual outcomes were noted. Results Glass fragments caused by the blast were the mechanism of all the ocular injuries in these patients. All patients had primary repair of the injuries done in Saudi Arabia and were sent to our institution for tertiary care. Three of the four eyes injured had stable or improved visual acuity and one eye was enucleated. Two patients had no serious injury other than the globe trauma. One patient had extensive eyelid trauma and required serial procedures to allow fitting of a prosthesis. Conclusions Blast-injury patients are at risk for open globe injury as a result of glass fragments. The types of injury that can occur from terrorist blasts can be extensive and involve all the tissues of the eye, the ocular adnexa, and the orbit.

Methods, statistical features, and baseline results of a standardized, multicentered ophthalmologic surgical trial: The silicone study

This article describes the trial design and baseline results for the Silicone Study, a multicenter, randomized surgical trial designed to compare the effectiveness of silicone fluid versus long-acting gas in the treatment of proliferative vitreoretinopathy (PVR). Design features include (1) standardization of the surgical protocol to reduce intersurgeon variability, (2) formulation of a PVR clinical classification system relevant to modern vitreoretinal surgery, and (3) creation of a photographic protocol to document PVR pathology. Statistical issues affecting the analysis of the outcome data include (1) the addition of a second group of patients with more severely diseased eyes after the trial began, (2) the change to a different long-acting gas during the course of the trial, and (3) recurrent retinal detachments that require reoperations with the randomized treatment, and, in some instances, a crossover from the randomized to the alternate treatment. Demographic and baseline ocular characteristics are presented for the two groups under study.