Loss Of Best Corrected Visual Acuity Research Articles

Vision Loss Reduction with Avacincaptad Pegol for Geographic Atrophy: A 12-Month Post Hoc Analysis of the GATHER1 and GATHER2 Trials

To evaluate the impact of reduction in geographic atrophy (GA) lesion growth on visual acuity in the GATHER trials using categorical outcome measures. Randomized, double-masked, sham-controlled phase 3 trials. Aged ≥50 years with noncenter point-involving GA and best-corrected visual acuity (BCVA) of 25 to 80 ETDRS letters in the study eye. GATHER1 consisted of 2 parts. In part 1, 77 patients were randomized 1:1:1 to avacincaptad pegol (ACP) 1 mg, ACP 2 mg, and sham. In part 2, 209 patients were randomized 1:2:2 to ACP 2 mg, ACP 4 mg, and sham. In GATHER2, patients were randomized 1:1 to ACP 2 mg (n= 225) and sham (n= 223). A post hoc analysis of 12-month data for pooled ACP 2 mg and sham groups is reported. Proportion of study eyes that experienced ≥10-, ≥15-, or ≥20-BCVA ETDRS letter loss from baseline to month 12; time-to-event analysis of persistent vision loss of ≥10, ≥15, or≥ 20 BCVA letters from baseline at ≥2 consecutive visits over 12 months; proportion of study eyes with BCVA loss to a level below driving eligibility threshold at month 12 among those eligible to drive at baseline. Lower proportions of study eyes experienced ≥10-, ≥15-, or ≥20-BCVA letter loss from baseline over 12 months with ACP 2 mg (11.6%, 4.0%, and 1.6%, respectively) versus sham (14.1%, 7.6%, and 4.5%, respectively). There was a reduction in the risk of persistent loss of ≥15 BCVA ETDRS letters with ACP 2 mg (3.4%) versus sham (7.8%) through 12 months. A lower proportion of study eyes treated with ACP 2 mg reached the threshold for driving ineligibility versus sham by 12 months. Treatment with ACP 2 mg delayed the risk of progression to persistent vision loss (i.e., ≥10-, ≥15-, and ≥20-BCVA letter loss or BCVA loss to a level below driving eligibility threshold) versus sham over 12 months. Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

Профилактика роговичных осложнений послеоперационного адъювантного применения антиметаболитов после непроникающей глубокой склерэктомии

Original article Prevention of corneal complications after post-operative application of antimetabolites following nonpenetrating deep sclerectomy S.N. Svetozarskii, A.N. Andreev, A.V. Shvaikin, S.V. Scherbakova, I.G. Smetankin Volga District Medical Center under the Federal Medical and Biological Agency, Nizhny Novgorod, Russian Federation Privolzhsky Research Medical University under the Ministr y of Health of Russia, Nizhny Novgorod, Russian Federation Purpose. To evaluate the clinical and functional effectiveness of the developed method for prevention of corneal complications of nonpenetrating deep sclerectomy (NPDS) with postoperative adjuvant use of 5-fluorouracil in comparison with the control group. Material and methods. Retrospective comparative study in 2 groups included patients with open angle glaucoma who were initially underwent NPDS and received at least 1 subconjunctival injection of 5-fluorouracil in the postoperative period. 1st group included 101 patients (101 eyes) who underwent subconjunctival injection of 5-fluorouracil after surgery using standard technique, 2nd group included 176 patients (176 eyes) who underwent subconjunctival injection of 5-fluorouracil with prophylaxis of corneal complications. Best corrected visual acuity (BCVA), intraocular pressure (IOP), frequency of corneal complications and number of visits to the doctor during the first 4 weeks after surgery were analyzed as criteria of efficacy and safety. Results. Comparison groups did not differ in demographic characteristics and preoperative BCVA and IOP parameters. Fluorescein stained corneal epithelium defects were statistically significantly more frequently observed in 1st group (38.6%) in comparison with 2nd group (7.4%) (p<0.001). Four weeks after NPDS, IOP decrease was 25.5% in 1st group and 31.5% in 2nd group (p=0.042). Mean BCVA loss was 1.9 lines in 1st group and 1.3 lines in 2nd group (p<0.001). The number of follow-up visits during the first month after surgery was 0.6 less in 2nd group than in 1st group (p=0.002). Conclusion. Prevention of corneal complications simply and effectively reduces the risk of corneal epithelial defects after subconjunctival injection of 5-fluorouracil as well as markedly improves the clinical and functional results of NPDS and reduces the need for outpatient visits. Key words: antimetabolites, open-angle glaucoma, corneal erosion, toxicity, prevention of complications

Genetics, Clinical Characteristics, and Natural History of PDE6B-Associated Retinal Dystrophy

To analyze the clinical characteristics, natural history, and genetics of PDE6B-associated retinal dystrophy. Retrospective, observational cohort study. Review of medical records and retinal imaging, including fundus autofluorescence (FAF) imaging and spectral-domain optical coherence tomography (SD-OCT) of patients with molecularly confirmed PDE6B-associated retinal dystrophy in a single tertiary referral center. Genetic results were reviewed, and the detected variants were assessed. Forty patients (80 eyes) were identified and evaluated longitudinally. The mean age (±SD, range) was 42.1 years (± 19.0, 10-86) at baseline, with a mean follow-up time of 5.2 years. Twenty-nine (72.5%) and 27 (67.5%) patients had no or mild visual acuity impairment at baseline and last visit, respectively. Best-corrected visual acuity (BCVA) was 0.56 ± 0.72 LogMAR (range -0.12 to 2.80) at baseline and 0.63 ± 0.73 LogMAR (range 0.0-2.80) at the last visit. BCVA was symmetrical in 87.5% of patients. A hyperautofluorescent ring was observed on FAF in 48 and 46 eyes at baseline and follow-up visit, respectively, with a mean area of 7.11 ± 4.13 mm2 at baseline and mean of 6.13 ± 3.62 mm2 at the follow-up visit. Mean horizontal ellipsoid zone width at baseline was 1946.1 ± 917.2 µm, which decreased to 1763.9 ± 827.9 µm at follow-up. Forty-four eyes had cystoid macular edema at baseline (55%), and 41 eyes (51.3%) at follow-up. There were statistically significant changes during the follow-up period in terms of BCVA and the ellipsoid zone width. Genetic analysis identified 43 variants in the PDE6B gene, including 16 novel variants. This study details the natural history of PDE6B-retinopathy in the largest cohort to date. Most patients had mild to no BCVA loss, with slowly progressive disease, based on FAF and OCT metrics. There is a high degree of disease symmetry and a wide window for intervention.

Long term follow up of patients with MNV3 treated with intra-vitreal Aflibercept.

MNV3 or Retinal angiomatous proliferation is a subtype of neovascular age-related macular degeneration (nAMD). We present the 5 year long term visual and anatomical outcomes of patients with MNV3 lesions treated with intravitreal Aflibercept. This is a prospective study of treatment naïve patients with reading centre graded MNV3 lesions. After the loading phase, the patients received intravitreal Aflibercept as per the View study up to year 3, thereafter it was given on a prn basis. At each visit, best corrected visual acuity (BCVA) and optical coherence tomography (OCT) central macular thickness (CMT) was measured. Thirty one patients reached study completion. Mean BCVA of treated eyes had decreased by 0.6 ETDRS letters at the end of year 5 compared with baseline. At study completion, 81% of eyes had stable vision while 19% of eyes had gained 15 letters or more. At study end, 26% of eyes had BCVA of 6/12 or better, while 19% had lost 15 letters or more (all had central foveal photoreceptor loss). There was a maximal mean reduction in CMT of 164 microns (p = <0.0001) while 68% of maculae were fluid free at study completion. Eighty seven percent of treated eyes developed nascent GA, of which in 74% of eyes was involving the fovea. Despite initial improvement in mean BCVA, the improvement in BCVA was not maintained despite good overall control of the MNV3 lesions. The loss of BCVA was most likely due to the majority of eyes developing centre involving macular atrophy.

Compartmental Exudative Dynamics in Neovascular Age-Related Macular Degeneration: Volumetric Outcomes and Impact of Volatility in a Phase III Clinical Trial

PurposeTo examine retinal feature dynamics in eyes with neovascular age-related macular degeneration (nAMD) treated with anti-vascular endothelial growth factor (anti-VEGF) therapy and the relationship of these features with visual acuity. DesignPost hoc analysis of the phase 3, randomized, HAWK nAMD clinical trial. ParticipantsParticipants randomized to the brolucizumab 6 mg or aflibercept 2 mg arms of the trial. MethodsSpectral domain optical coherence tomography (OCT) scans collected at 4-week intervals were analyzed using an automated machine learning-enhanced segmentation and feature-extraction platform with manual verification. Quantitative volumetric measures of retinal and exudative features were exported at multiple timepoints over 48 weeks. Volatility of exudative features was calculated as the standard deviation of each feature value during the maintenance phase (week 12–48) of treatment. These features were examined for their associations with anatomic and functional outcomes. Main Outcome MeasuresLongitudinal intraretinal fluid (IRF) and subretinal fluid (SRF) volume, subretinal hyperreflective material (SHRM) volume, ellipsoid zone (EZ) integrity (EZ-retinal pigment epithelium [RPE] volume/thickness), and correlation with best corrected visual acuity (BCVA). ResultsIRF, SRF, and SHRM demonstrated significant volumetric reduction from baseline with anti-VEGF therapy (P<0.001 at each timepoint). EZ integrity measures demonstrated significant improvement from baseline (P<0.001 at each timepoint). Both EZ integrity and SHRM measures significantly correlated with BCVA at all timepoints (EZ-RPE volume: 0.38≤ r ≤0.47; EZ-RPE central subfield thickness: 0.22≤ r ≤0.41; SHRM volume: -0.33≤ r ≤-0.44). Following treatment initiation, correlations of IRF and SRF volume with BCVA were weak or nonsignificant. Eyes with lower volatility of IRF, SRF, and SHRM volumes during the maintenance phase showed greater improvements in EZ integrity (all P<0.01) and greater gains in BCVA (all P<0.01) at week 48 compared to eyes with higher volatility in those exudative parameters. ConclusionsQuantitative measures of SHRM volume and EZ integrity correlated more strongly with BCVA than retinal fluid volumes during treatment. High volatility of exudative parameters, including SRF, during the maintenance phase of treatment was associated with loss of EZ integrity and BCVA.

Single Center Experience with Voretigene Neparvovec Gene Augmentation Therapy in RPE65 Mutation–Associated Inherited Retinal Degeneration in a Clinical Setting

To assess the impact of baseline data on psychophysical and morphological outcomes of subretinal voretigene neparvovec (VN) (Luxturna, Spark Therapeutics, Inc.) treatment. Single-center, retrospective, longitudinal, consecutive case series. Patients with RPE65-biallelic mutation-associated inherited retinal degeneration (RPE65-IRD) treated between February 2020 and March 2022 with VN and oral immunosuppression according to the manufacturer's recommendation by one surgeon (F.G.H.). Retrospective analysis of surgical and clinical records, ancillary testing, and retinal imaging after VN therapy for RPE65-IRD. Descriptive statistics compared data at baseline up to 32 months post-treatment. Best-corrected visual acuity (BCVA), low-luminance VA (LLVA), Goldmann visual fields (GVFs), chromatic full-field stimulus threshold (FST) testing (FST), scotopic and photopic 2-color threshold perimetry (2CTP), and multimodal retinal imaging. Thirty eyes of 19 patients were analyzed (10 pediatric patients < 20 years; 20 adult patients > 20 years of age; overall range: 8-40 years) with a median follow-up of 15 months (range, 1-32). The fovea was completely or partially detached in 16 eyes, attached in 12 eyes, and not assessable in 2 eyes on intraoperative imaging. Median BCVA at baseline was better in the pediatric group (P < 0.05) and did not change significantly independent of age. Meaningful loss of BCVA (≥ 0.3 logarithm of the minimal angle of resolution [logMAR]) occurred in 5 of 18 adult eyes, and a meaningful gain (≥-0.3 logMAR) occurred in 2 of 18 adult and 2 of 8 pediatric eyes. The LLVA and scotopic 2CTP improved considerably in pediatric patients. Scotopic blue FST improved at all ages but more in pediatric patients (8/8 eyes gained ≥ 10 decibels [dB]; P < 0.05). In pediatric patients, median GVF improved by 20% for target V4e and by 50% for target III4e (target I4e not detected). Novel atrophy developed in 13 of 26 eyes at the site of the bleb or peripheral of vascular arcades. Improvements in FST did not correlate with development of chorioretinal atrophy at 12 months. Mean central retinal thickness was 165.87 μm (± 26.26) at baseline (30 eyes) and 157.69 μm (± 30.3) at 12 months (26 eyes). Eight adult patients were treated unilaterally. The untreated eyes did not show meaningful changes during follow-up. These data in a clinical setting show the effectiveness of VN therapy with stable median BCVA and mean retinal thickness and improvements of LLVA, FST, and 2CTP up to 32 months. Treatment effects were superior in the pediatric group. We observed new chorioretinal atrophy in 50% of the treated eyes. Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

An easy and safe method of subconjunctival injection of antimetabolites in glaucoma surgery

Aim: The use of 5-fluorouracil in glaucoma surgery is associated with a high risk of corneal complications, as even minimal doses of the drug at the ocular surface inhibit corneal epithelial cell division and lead to corneal epitheliopathy and erosion. The aim of this study was to evaluate the clinical and functional results of the proposed method of postoperative adjuvant subconjunctival injection of 5-fluorouracil after non-penetrating deep sclerectomy (NPDS) in comparison with the control group. Methods: Patients with primary open-angle glaucoma who underwent NPDS and received at least 1 subconjunctival injection of 5-fluorouracil in the postoperative period were included in a two-group retrospective comparative study. Patients who received a subconjunctival injection of 5-fluorouracil after surgery using the standard technique were included in Group 1; Group 2 included patients who received an injection using the proposed method. Best-corrected visual acuity (BCVA), intraocular pressure (IOP), rate of corneal complications, and number of office visits during the first 4 weeks after surgery were analysed. Results: The compared groups did not differ in demographic characteristics, preoperative BCVA, and IOP parameters. Fluorescein-stained corneal epithelial defects were statistically significantly more frequent in Group 1 compared to Group 2, P &lt; 0.001. Four weeks post NPDS IOP reduction was greater in Group 2, P = 0.042. Mean BCVA loss was 1.9 lines in Group 1 and 1.3 lines in Group 2, P &lt; 0.001. The number of follow-up visits during the first month after surgery was lower in Group 2 than in Group 1, P = 0.002. Conclusions: The proposed method was simple and effective in reducing the risk of corneal epithelial defects after subconjunctival injection of 5-fluorouracil, significantly improving clinical and functional outcomes of NPDS and reducing the need for outpatient visits.

Detection and Management of Intraocular Inflammation after Brolucizumab Treatment for Neovascular Age-Related Macular Degeneration

To present interim descriptive insights from the OCTOPUS and SWIFT studies on incidence, clinical features, management, and outcomes of intraocular inflammation (IOI), vasculitis, and occlusive vasculitis with brolucizumab treatment (Beovu, Novartis) in patients with neovascular age-related macular degeneration (nAMD) who were anti-VEGF naive or pretreated with anti-VEGFs (ranibizumab or aflibercept). OCTOPUS (NCT04239027) and SWIFT (NCT04264819) studies are prospective phase IIIb single-arm, open-label, multicenter studies assessing brolucizumab. Anti-VEGF naive (OCTOPUS) and pretreated (SWIFT) patients with nAMD. Interim prespecified analysis on the efficacy end point provided an opportunity to analyze IOI-related safety. Reports of IOI-related adverse events (AEs) were reviewed, and AE images and clinical features and outcomes of each case were analyzed by a review committee. Of 505 brolucizumab-treated eyes/patients with median brolucizumab treatment of 8.8 months, 53 eyes demonstrated at least 1 IOI-related AE. The incidence of overall IOI-related AEs was 10.5%; among these events, the incidence was 7.1% for IOI only without retinal involvement and 3.4% for IOI with retinal involvement (2.0% with vasculitis, 1.4% with vascular occlusion with or without vasculitis). Incidence was similar in naive and pretreated patients. Before the onset of the first IOI-related AE, eyes received a median of 2 brolucizumab injections; 81.1% of IOI-related AEs occurred during the loading phase (median, 25.0 days from the last brolucizumab injection). At AE onset, most frequently reported symptoms were floaters (52.8%) and blurred or decreased vision (37.8%). Of the 86.8% of AEs that were treated, most were treated with topical corticosteroids (75.5%), 28.3% by systemic corticosteroids, and 26.8% by intraocular corticosteroids. No severe vision loss was reported for the 7 nontreated AEs. Overall, the median best-corrected visual acuity (BCVA) change at IOI-related AEs resolution from baseline was 1 letter (range,-74 to+32 letters), and 2 patients with occlusive vasculitis had BCVA loss ≥ 15 letters due to IOI-related AEs. All eyes permanently discontinued brolucizumab after the first IOI-related AE. This analysis highlights the need for monitoring and education of patients to report any signs of IOI-related events immediately when being treated with brolucizumab. IOI should be treated promptly and intensely with corticosteroids. Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

First-in-Human Safety Study of Femtosecond Laser Image-Guided Trabeculotomy for Glaucoma Treatment: 24-month Outcomes

Pilot study to evaluate adverse events and intraocular pressure (IOP)-lowering of a novel, noninvasive glaucoma procedure, femtosecond laser, image-guided, high-precision trabeculotomy (FLIGHT). Prospective, nonrandomized, single-center, interventional, single-arm clinical trial. Eighteen eyes from 12 patients with open-angle glaucoma. Eighteen eyes from 12 patients underwent FLIGHT, creating a single channel measuring 500-μm wide by 200-μm high through the trabecular meshwork and into Schlemm's canal. Adverse events, IOP, and other parameters were evaluated out to 24 months. Outcomes were the rates and types of adverse events and the rate of postprocedure best-corrected visual acuity loss (≥ 2 lines) compared with baseline. Efficacy outcomes were reduction in mean intraocular pressure (IOP) with respect to baseline and the percentage of eyes with a ≥ 20% reduction in IOP. Eighteen eyes from 12 patients were enrolled in the study; 11 patients (17 eyes) returned at 24 months. There were no serious adverse events related to the laser treatment. Well-defined channels were clearly visible at 24 months by gonioscopy and anterior segment OCT, with no evidence of closure. At 24 months, the mean IOP was reduced by 34.6% from 22.3 ± 5.5 to 14.5 ± 2.6 mmHg (P < 5e-5), with an average of 2.0 ± 1.2 hypotensive medications compared with 2.2 ± 1.1 at baseline (P= 0.22). Fourteen out of the 17 study eyes (82.3%) achieved a ≥ 20% reduction in IOP at 24 months when compared with baseline. The FLIGHT system demonstrated a favorable safety profile in this initial pilot study, with no device-related serious adverse events. The channels appeared patent at 24 months, indicating medium-term durability. Proprietary or commercial disclosure may be found after the references.

Anatomical and functional impact of verteporfin shortage in patients with chronic central serous chorioretinopathy

BackgroundTo describe the functional and anatomical impact that the worldwide shortage of verteporfin has had on patients diagnosed with chronic central serous chorioretinopathy (cCSCR) whose treatment with photodynamic therapy (PDT) had to be delayed. MethodsProspective observational study. Patients were divided into two groups based on the time interval since PDT had been indicated: groups 1 and 2, with waiting times of less and more than 9 months respectively. Best corrected visual acuity (BCVA), the maximum height of the subretinal fluid (MSRF) and subfoveal choroidal thickness (SFCT) at the baseline visit and the last visit were compared. Results49 eyes of 48 patients with cCSCR were included. The mean waiting time for PDT was 9.0 ±3.8 months. The mean BCVA was 69.0 ±17.1 letters and 68.9 ±16.4 letters for the baseline and last visit respectively, showing no difference (p= 0.958). Although there was no difference in the mean global BCVA, 15 eyes (30.5%) showed a deterioration of ≥5 letters, including 7 eyes (14%) with a decrease of ≥10 letters. Mean MSRF height was 151.4 ±97.2 μm and 98.2 ±83.1 μm for the baseline and last visit respectively (p= 0.005), persisting in 74.5% of the eyes. ConclusionNo significant impact was observed in the BCVA in cCSCR due to the shortage of verteporfin. However, one-third of patients had BCVA loss. There was a significant spontaneous decrease in MSRF, but it persisted in the majority of the patients, still susceptible to PDT.

Use of a three-dimensional head-mounted digital visualization platform in cataract surgery.

To report preliminary experience using the BeyeonicsOne (Beyeonics Vision, Haifa, Israel) digital visualization platform and the utilization of its three-dimensional (3D) head-mounted display(HMD) in cataract surgery. An interventional case series including patients who underwent cataract surgery using the 3D HMD platform at the Tel Aviv Medical Center. The system uses the HMD unit to display high-resolution real-time 3D surgical field images. Collected data included patient demographics, ocular comorbidities, risk factors for complex cataract surgery, cataract grading, preoperative and postoperative best-corrected visual acuity (BCVA), and intra- and postoperative complications. In total, 60 eyes of 60 subjects (mean age 73.1 ± 8.4 years) were included. Mean preoperative BCVA was 0.40 ± 0.30 logMAR (Snellen equivalent ~20/50) and improved to 0.10 ± 0.10 logMAR (Snellen equivalent ~20/25, p < 0.001). None of the patients suffered BCVA loss. All procedures and follow-ups were uneventful except for one case of a posterior capsular tear and one case of post-surgical cystoid macular edema. The visualization platform and its embedded 3D head-mounted display can be easily used in routine cataract surgery with the added benefits of improved ergonomics, high picture quality and enhanced image control.

Management of Post-LASIK Ectasia.

Corneal ectasia is a sight-threatening complication of corneal refractive surgery characterized by progressive steepening and thinning of the cornea and subsequent loss of best-corrected visual acuity. To report the clinical outcomes following treatment of post-laser in situ keratomileusis (LASIK) induced ectasia. This is a retrospective case series of 7 patients (10 eyes) which developed post-LASIK ectasia. In these cases of postoperative ectasia, the presented clinical signs were either forme fruste keratoconus, thin cornea, posterior elevation map value > +15.0µm, or residual stromal bed < 300µm. All cases were treated with either collagen crosslinking (CXL) alone or combined with PRK or CXL and phakic intraocular implant using the Dresden protocol and a slight modification thereof. In all cases, the flap was created using the Moria M2 mechanical microkeratome (average flap thickness 118.15±12.88µm), and refractive error was corrected using the Wavelight Allegretto excimer laser. Average preoperative corrected visual acuity (CDVA) was 0.75 (±0.26) Snellen. Postoperative CDVA significantly increased to 0.86 (±0.13) Snellen (p=0.04, paired t-test). One eye lost three lines of its baseline CDVA (before ectasia), while all other eyes regained lines of CDVA. All cases remained stable during the follow-up. Several surgical procedures are used for the management of corneal ectasia. However, the best surgical approach should be determined based on the state of progression of the disease. Although ectasia remains a potentially devastating complication after refractive surgery, most patients can regain functional visual acuity with appropriate management, and corneal transplantation is infrequently indicated.

A Multicenter 12-Month Retrospective Evaluation of Canaloplasty and Trabeculotomy in Patients with Open-Angle Glaucoma: The ROMEO 2 Study.

PurposeTwelve-month safety and effectiveness results for canaloplasty combined with trabeculotomy using the OMNI surgical system in pseudophakic eyes or combined with cataract surgery in mild-to-moderate open-angle glaucoma (OAG).SettingSixteen centers in 11 US states (AL, AR, CA, CT, KS, LA, MO, NY, SD, TN, TX).DesignRetrospective, case series, open-label.MethodsA total of 136 eligible patients from 20 surgeons: mild-to-moderate OAG (visual field mean deviation (MD) not worse than −12 dB), 12-month follow-up, preoperative medicated IOP >18 mmHg and ≤36 mmHg on ≤5 medications. One eye per patient enrolled. Endpoints included proportion with ≥20% reduction in IOP or IOP between 6 and 18 mmHg (inclusive) and on the same or fewer medications without secondary surgical intervention (SSI) (primary success), mean IOP, change in IOP, ocular hypotensive medication use, and proportion of patients with a 20% or greater reduction in IOP at 12 months. Safety: adverse events (AE) and best corrected visual acuity (BCVA).ResultsPrimary success was met by 71%. Mean IOP was reduced (22.3–15.9 mmHg, p < 0.0001). Medications went from 1.9 ± 1.3 to 1.3 ± 1.2 (p < 0.001). AE were mild and as expected for angle surgery. The most frequent AE were BCVA loss (6%), mild inflammation (4%), IOP elevation (3%), and clinically significant hyphema (3%). There were 4 (3%) SSI.ConclusionThe OMNI system provides effective IOP reduction, sustained IOP control, and meaningful medication reduction for up to 12 months postoperative. The present study confirms and extends the results from ROMEO.

Visual acuity after cataract surgery in Macular Telangiectasia Type 2 Stage 3 to 5

BackgroundThe purpose of this study was to evaluate visual acuity after cataract surgery in eyes with Macular Telangiectasia (MacTel) Type 2.MethodsSingle-center retrospective cohort study of patients with MacTel Type 2 who underwent cataract surgery and were managed at the same institution. Patients underwent pre-operative assessment by a retinal specialist with examination and optical coherence tomography (OCT) at the same institution. The main outcome measure was the post-operative change in best corrected visual acuity (BCVA). Secondary study outcomes were achieving post-operative BCVA better than Snellen acuity of 20/40 and time to BCVA loss by two lines or more (10 or more ETDRS letters).ResultsA total of 20 eyes (11 patients) underwent cataract surgery and were followed for a median of 25.5 months (IQR 17.5–44.2 months). The median post-operative BCVA improvement was 10.5 letters (IQR 3.50–20.25). Nuclear sclerosis severity [β = 8.99 (95% CI 3.35, 14.6), p = 0.00177] was associated with post-operative change in BCVA and central foveal ellipsoid zone (EZ) breaks [OR 1.33 × 10–9 (95% CI 5.12 × 10–10–3.43 × 10−9), p < 0.001] on OCT was inversely correlated with post-operative BCVA > 20/40 using a multivariate generalized linear model. Central foveal EZ breaks [HR 1.77 × 109 (95% CI 3.86 × 108, 8.11 × 109), p < 0.001] and MacTel Type 2 disease stage [HR 2.83, (95% CI 1.12, 7.12), p = 0.027] were independently associated with shorter time to vision loss of two lines or more in a multivariate Cox regression model.ConclusionsVisual acuity significant improved after cataract surgery in eyes with MacTel Type 2 regardless of disease severity. The presence of central foveal EZ breaks may predict poorer post-operative visual acuity and subsequent vision loss from disease progression.

MERLIN: Phase 3a, Multicenter, Randomized, Double-Masked Trial of Brolucizumab in Participants with Neovascular Age-Related Macular Degeneration and Persistent Retinal Fluid

To assess the 52-week efficacy and safety of brolucizumab 6 mg administered every 4 weeks compared with aflibercept 2 mg dosed every 4 weeks in eyes with neovascular age-related macular degeneration (nAMD) and persistent retinal fluid. Multicenter, randomized, double-masked phase 3a study. Participants with recalcitrant nAMD (persistent residual retinal fluid despite previous frequent anti-vascular endothelial growth factor treatment). Eyes were randomized (2:1) to intravitreal brolucizumab 6 mg or aflibercept 2 mg every 4 weeks up to and including week100. The primary end point was analysis of noninferiority in mean best-corrected visual acuity (BCVA) change from baseline to week 52 (margin, 4 letters). Other key end points included change in central subfield thickness (CST) from baseline to week 52, fluid-free status (no intraretinal fluid and no subretinal fluid), and safety. At week 52, brolucizumab was noninferior to aflibercept in BCVA change from baseline (least squares mean difference, -0.6 Early Treatment Diabetic Retinopathy Study letters; 95% confidence interval [CI], -2.1 to 0.9; P < 0.001). A total of 4.8% and 1.7% of participants reported a 15-letter or more BCVA loss from baseline at week 52 in the brolucizumab and aflibercept groups, respectively. In eyes treated with brolucizumab compared with those treated with aflibercept, the CST was reduced significantly (P < 0.001), and a significantly greater proportion of eyes were fluid free at week 52 (40.4% brolucizumab vs. 19.0% aflibercept; 95% CI, 13.9-29.0; P < 0.001). Incidence of intraocular inflammation (IOI), including retinal vasculitis and retinal vascular occlusion, were 9.3% (0.8% and 2.0%) for brolucizumab versus 4.5% (0% and 0%) for aflibercept, respectively. Visual acuity outcomes in previously treated participants with nAMD and persistent retinal fluid receiving brolucizumab 6 mg dosed every 4 weeks were noninferior to aflibercept 2 mg dosed every 4 weeks, with superior anatomic outcomes. However, incidences of IOI, including retinal vasculitis and retinal vascular occlusion, also were higher, leading to study termination.

Retinal Phenotype of Patients with CLRN1-Associated Usher 3A Syndrome in French Light4Deaf Cohort.

PurposeBiallelic variants in CLRN1 are responsible for Usher syndrome 3A and non-syndromic rod–cone dystrophy (RCD). Retinal findings in Usher syndrome 3A have not been well defined. We report the detailed phenotypic description of RCD associated with CLRN1 variants in a prospective cohort.MethodsPatients were clinically investigated at the National Reference Center for rare ocular diseases at the Quinze-Vingts Hospital, Paris, France. Best-corrected visual acuity (BCVA) tests, Goldmann perimetry, full-field electroretinography (ffERG), retinal photography, near-infrared reflectance, short-wavelength and near-infrared autofluorescence, and optical coherence tomography (OCT) were performed for all patients.ResultsFour patients from four unrelated families were recruited. Mean follow-up was 11 years for three patients, and only baseline data were available for one subject. Median BCVA at baseline was 0.2 logMAR (range, 0.3–0). ffERG responses were undetectable in all subjects. The III4e isopter of the Goldmann visual field was constricted to 10°. The retinal phenotype was consistent in all patients: small whitish granular atrophic areas were organized in a network pattern around the macula and in the midperiphery. OCT showed intraretinal microcysts in all patients. Upon follow-up, all patients experienced a progressive BCVA loss and further visual field constriction. Four distinct pathogenic variants were identified in our patients: two missense (c.144T>G, p.(Asn48Lys) and c.368C>A, p.(Ala123Asp)) and two frameshift variants (c.176del, p.(Gly59Valfs*13) and c.230dup, p.(Ala78Serfs*52)).ConclusionsRCD in Usher 3A syndrome has some distinctive features. It is a severe photoreceptor dystrophy with whitish granular posterior pole appearance and cystic maculopathy.

IMPACT OF RESIDUAL SUBRETINAL FLUID VOLUMES ON TREATMENT OUTCOMES IN A SUBRETINAL FLUID-TOLERANT TREAT-AND-EXTEND REGIMEN.

To investigate associations between residual subretinal fluid (rSRF) volumes, quantified using artificial intelligence and treatment outcomes in a subretinal fluid (SRF)-tolerant treat-and-extend (T&E) regimen in neovascular age-related macular degeneration. Patients enrolled in the prospective, multicenter FLUID study randomized in an SRF-tolerant T&E regimen were examined by spectral-domain optical coherence tomography and tested for best-corrected visual acuity (BCVA). Intraretinal fluid and SRF volumes were quantified using artificial intelligence tools. In total, 375 visits of 98 patients were divided into subgroups: extended intervals despite rSRF and extended intervals without fluid. Associations between BCVA change, SRF volume, subgroups, and treatment intervals were estimated using linear mixed models. In extended intervals despite rSRF, increased SRF was associated with reduced BCVA at the next visit in the central 1 mm (-0.138 letters per nL; P = 0.014) and 6 mm (-0.024 letters per nL; P = 0.049). A negative association between increased interval and BCVA change was found for rSRF in 1 mm and 6 mm (-0.250 and -0.233 letter per week interval, respectively; both P < 0.001). Extended intervals despite rSRF had significantly higher SRF volumes in the central 6 mm at the following visit (P = 0.002). Artificial intelligence-based analysis of extended visits despite rSRF demonstrated increasing SRF volumes associated with BCVA loss at the consecutive visit. This negative association contributes to the understanding of rSRF volumes on treatment outcomes in neovascular age-related macular degeneration.

Effectiveness of Difluprednate for the Treatment of Anterior Scleritis

To describe the effectiveness and side effect profile of difluprednate therapy in a series of patients with anterior scleritis. Retrospective, interventional case series. Data collected from all patients with anterior scleritis who used difluprednate as a single treatment agent from January 1, 2018, to January 1, 2020, including demographics, scleritis type, presence of nodules or necrosis, changes in scleritis activity, intraocular pressure (IOP), number of difluprednate drops used, best-corrected visual acuity (BCVA), and lens status. The primary outcome was clinical resolution of scleritis. Secondary outcomes included BCVA loss ≥2 lines, change in lens status or cataract surgery, and IOP ≥24 mm Hg. Twenty-five patients (35 eyes) were analyzed. The median age was 60 years (range 13-78); 60% were female; 64% were White. Forty percent had bilateral disease, and 44% of patients had an associated systemic disease. The majority of eyes (66%) had diffuse anterior scleritis. Eighty-three percent of eyes achieved resolution of scleritis, with a median time of resolution of 6 weeks. Eyes treated with an initial dose of ≥4 times daily were more likely to achieve disease resolution (hazard ratio [HR]=3.43, 95% confidence interval [CI] 1.19, 9.88, P=.02). Nine eyes had IOP elevation. Four eyes lost ≥2 lines of BCVA, and 1 due to cataract progression. One eye underwent cataract surgery. Difluprednate alone may effectively treat non-infectious anterior scleritis with a tolerable side effect profile.

Early DMO: a predictor of poor outcomes following cataract surgery in diabetic patients. The DICAT-II study.

BackgroundThe prospective DIabetes and CATaract Study II (DICAT II) was performed to characterise the risks of cataract surgery to the retinae of patients with early diabetic macular oedema (E-DMO).MethodsDICAT II was a prospective, comparative, multicentre, observational study involving six Italian clinics. Patients were aged ≥55 years, had type 1 or 2 diabetes with spectral-domain optical coherence tomography evidence of ESASO classification Early DMO. Group 1 eyes (78 eyes, 78 patients) underwent phacoemulsification-based cataract surgery. Group 2 eyes (65 eyes, 65 patients) had E-DMO and either clear media or had undergone uncomplicated cataract surgery ≥1 year previously. Central subfield thickness (CST) and best-corrected visual acuity (BCVA) were assessed in both groups.ResultsThe negative impact of surgery on CST was evident after the first postoperative week; CST peaked during the first month, then rapidly decreased. CST worsening ≥10 µm was observed in 63/78 eyes (80.7%) and 29/65 eyes (44.6%) in Groups 1 and 2, respectively (p < 0.0001). CST worsening of ≥50 µm was observed in 51 eyes (65.4%) and 10 eyes (15.4%) in Groups 1 and 2, respectively (p < 0.0001). Mean CST worsening was lower in Group 2 than in Group 1 (38.6 ± 30.4 µm vs 85.5 ± 55.3 µm, p < 0.0001) with a lower BCVA loss (−2.6 ± 3.5 letters vs −8.2 ± 6.2 letters, p < 0.0001). Higher glycaemic levels and HBA1c levels were significantly associated with the risk of >50 μm CST worsening in eyes from both groups.ConclusionEarly DMO is associated with poorer outcomes after cataract surgery and requires close pre- and postoperative monitoring.

Foveal structure and visual function in nanophthalmos and posterior microphthalmos

Background/aimsThe reason for visual impairment in patients with nanophthalmos and posterior microphthalmos is not completely understood. Therefore, this study aims to investigate foveal structure, and the impact of demographic, clinical...