Change In Best-corrected Visual Acuity Research Articles

Efficacy and safety of complement inhibitors in patients with geographic atrophy associated with age-related macular degeneration: a network meta-analysis of randomized controlled trials

ImportanceClinical trials in recent years have shown significant effectiveness of complement inhibitors for geographic atrophy (GA) treatment. Two complement inhibitor drugs have been approved by the Food and Drug Administration (FDA).Objectiveto compare and rank the different complement inhibitors in the treatment of GA secondary to age-related macular degeneration (AMD).Data sourcesA systematic literature search was conducted in the Cochrane Central, Web of Science Core Collection, PubMed, LWW Medical Journals, ClinicalTrials.gov, and WHO ICTRP from inception to October 2023.Study selectionAll randomized clinical trials evaluating the effectiveness of complement inhibitors in patients diagnosed with secondary GA in AMD were identified.Data extraction and synthesisThis study followed Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) network meta-analysis Checklist of Items and the Cochrane Risk of Bias Assessment Tool for assessing the study quality. Multiple authors independently coded all titles and abstracts, reviewed full-text articles against the inclusion and exclusion criteria, and resolved all discrepancies by consensus. Random-effects network meta-analyses were applied. Bayesian network meta-analysis was performed using the BUGSnet package in R (4.2.0).Main outcomes and measuresThe primary efficacy outcome was the change in GA lesion size (mm2) from baseline to month 12. The secondary efficacy outcome was the mean change in best-corrected visual acuity (BCVA) from baseline to month 12. Safety outcome measures included the number of subjects with serious adverse events (SAEs) and macular neovascularization (MNV).ResultsTen randomized controlled trials including 4,405 participants and five complement inhibitors were identified. Comparison with sham and SUCRA analysis showed that avacincaptad pegol 2 mg (MD: −0.58, 95% CrI: −0.97 to −0.18, SUCRA: 93.55), pegcetacoplan monthly (MD: −0.38, 95% CrI: −0.57 to −0.20, SUCRA: 81.37), and pegcetacoplan every other month (MD: −0.30, 95% CrI: −0.49 to −0.11, SUCRA: 70.16) have significant changes in GA lesion reduction. No treatments showed significant changes in BCVA and SAE compared with sham. Pegcetacoplan monthly (OR: 4.30, 95% CrI: 1.48–16.72) increased the risk of MNV. Avacincaptad pegol 2 mg demonstrated favorable outcomes in terms of SAE and MNV.Conclusion and relevanceAvacincaptad pegol 2 mg is the most effective complement inhibitor with better safety for the treatment of GA secondary to AMD.Systematic Review Registrationhttps://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42022351515, Identifier PROSPERO CRD42022351515.

A pilot study : retinal sensitivity change in neovascular age-related macular degeneration patients with better baseline visual acuity

This study evaluated changes in retinal sensitivity (RS) during aflibercept treatment in neovascular age-related macular degeneration (nAMD) patients with good vision. Treatment-naive nAMD patients with visual acuity better than 20/40 were treated with an aflibercept loading regiment, and RS was measured using the MAIA microperimetry device. The study examined RS differences based on visit, region, adjacent local pathology, outer retinal changes and optical coherence tomography angiography (OCTA) data were investigated. Twelve patients completed the protocol. Mean RS improved from 17.9 (3.9) µm at baseline to 20.4 (4.7) µm at final visit, while best-corrected visual acuity (BCVA) did not change. (P = 0.041) RS at baseline is worst in the presence of intraretinal fluid (IRF) and improved after treatment for all retinal pathologies except IRF. RS improvement occurred even with initial outer retinal damage. A Linear mixed model showed subretinal hyperreflective material, baseline IRF height, outer retinal integrity, fibrovascular pigment epithelial detachment height, and local choroidal vascular index as factors associated with RS. In conclusion, RS improved with aflibercept treatment in nAMD eyes with good initial visual acuity, despite no change in BCVA, except when IRF was present.

The safe lowest effective power of subthreshold micropulse laser treatment in Chinese patients with acute or chronic central serous chorioretinopathy

PurposeTo assess the safe, lowest effective laser power of subthreshold micropulse laser (SML) for treating acute and chronic central serous chorioretinopathy (CSC) in Chinese patients.MethodsPatients were distinguished with acute or chronic CSC based on focal or diffuse retinal pigment epithelium (RPE) leakage on fundus fluorescein angiography (FFA), with or without widespread RPE decompensation. Patients were categorized into five groups and treated with 577 nm yellow SML according to 50% titration power. The change of best-corrected visual acuity (BCVA) and central macular thickness (CMT) were set as primary outcomes. A linear regression model assessed the correlation between different factors and outcome indicators.ResultsA total of 103 patients with 127 eyes (61 with acute CSC and 66 with chronic CSC) were enrolled. The baseline characteristics were balanced between the five groups (all p > 0.05). The decrease of CMT and the improvement of BCVA were related to the CMT at baseline (all p < 0.05). We found that the lowest effective laser power for acute CSC was 425 mW (−225.50 μm vs. −171.24 μm vs. −114.50 μm vs. −130.54 μm vs. −68.00 μm, p < 0.001), showing a significant CMT reduction at this power, but no significant increase in BCVA (−0.15 ± 0.10 logMAR vs. −0.20 ± 0.16 logMAR vs. −0.14 ± 0.11 logMAR vs. −0.17 ± 0.30 logMAR vs. −0.11 ± 0.14 logMAR, p > 0.05). For chronic CSC, the lowest effective laser power was 375 mW (p = 0.01), the change of CMT was significant in 375 mW (−93.91 ± 109.06 μm, −119.32 ± 105.56 μm, −88.67 ± 67.26 μm, −60.89 ± 106.86 μm, and −99.11 ± 157.32 μm, p = 0.04). The change of BCVA was similar trend (−0.54 ± 0.66 logMAR vs. −0.17 ± 0.23 logMAR vs. −0.10 ± 0.21 logMAR vs. −0.02 ± 0.30 logMAR vs. 0.05 ± 0.19 logMAR, p < 0.001).ConclusionIn this study, our results suggested 425 mW and 375 mW laser power is the lowest effective SML power for treating acute and chronic CSC in Chinese patients respectively, And the power of SML for chronic CSC requires lower power than acute CSC.

Hereditary vitreoretinal amyloidosis with transthyretin Gly83Arg variant, a long-term study.

This study evaluated the clinical data on ophthalmic follow-up and treatment efficacy of hereditary vitreoretinal amyloidosis kindred due to transthyretin Gly83Arg variant over a 15-year follow-up period. The clinical data of patients with hereditary ATTRG83R amyloidosis from 2006 to 2021 were analysed retrospectively. Sanger sequencing of the transthyretin gene, detailed medical history, pedigree charting, and systemic and ophthalmic examinations were carried out in all patients. The changes of best-corrected visual acuity (BCVA) after vitrectomy and the associations of amyloidosis recurrence and post-vitrectomy glaucoma were analysed. Fourteen patients with ATTRG83R were included, all experiencing vision loss due to vitreous opacities. The average age of onset was 40.93 ± 6.96 (29 to 52) years. The preoperative BCVA was 2.20 ± 0.69 logMAR, whereas the postoperative BCVA improved to 0.13 ± 0.35 logMAR (P < 0.05). The recurrence time was 58.83 ± 20.85 months after vitrectomy. At 90 months after vitrectomy, the cumulative recurrence rate was 94.7%. Eight eyes developed glaucoma after vitrectomy. None of the 5 eyes without vitrectomy developed glaucoma. Paired chi-square test showed a significant difference in the incidence rate of glaucoma between eyes with or without vitrectomy (P < 0.05). However, retinal amyloid angiopathy and cataract surgery were not associated with glaucoma (P > 0.05). Poor intraocular pressure control in 7 eyes resulted in severe visual impairment. Hereditary ATTRG83R amyloidosis predominantly manifests as vitreous opacity, and vitrectomy can improve the visual acuity in affected patients. However, the recurrence of amyloidosis and related complications significantly impact long-term visual outcomes. Thus, delaying vitrectomy appropriately and maintaining regular follow-up visits is advisable.

Development and preliminary evaluation of a novel preoperative index for quantitative analysis of photoreceptor loss in full-thickness macular holes.

To identify novel quantitative parameters for evaluating photoreceptor loss in full-thickness macular holes (FTMH), exploring their potential clinical impact on postoperative functional and anatomical recovery. This pilot study enrolled 38 eyes from 38 patients diagnosed with FTMH. Preoperatively, eyes underwent analysis and were subsequently followed for six months post-surgery. Best-corrected visual acuity (BCVA) was recorded, and cross-sectional images of FTMH were obtained using B-scan optical coherence tomography (OCT) and en-face OCT. Quantitative assessment of ellipsoid zone (EZ) and external limiting membrane (ELM) integrity changes was conducted and correlated with postoperative anatomical and functional recovery. The photoreceptor Integrity Index (PIIN), calculated as the ratio of photoreceptor area to lumen hole area measured at customized segmentation, was correlated with the minimum and base diameters of the hole, positive change in BCVA, preoperative EZ defect (EZd), preoperative ELM defect (ELMd), and changes in EZ and ELM over the six-month follow-up period (∆-EZ and ∆-ELM). The main outcome measures focused on evaluating the effectiveness of PIIN in predicting postoperative anatomical and functional changes. A higher PIIN correlated with a greater BCVA change over six months (p < 0.001). Univariate regression analysis using the PIIN as a predictor for positive change in BCVA (|∆-BCVA| [logMAR]) over time yielded significant results (p < 0.001). Additionally, the PIIN significantly correlated with EZd at baseline, ELM at baseline, and ELMd change over the six-month follow-up period. The PIIN shows promise as a tool for evaluating photoreceptor loss in macular holes and estimating postoperative functional and anatomical recovery. What is known Previous studies have extensively used optical coherence tomography (OCT) to investigate various biomarkers for assessing patients with full-thickness macular hole (FTMH), without considering detailed MH ultrastructural features Existing indexes used to predict surgical outcomes for FTMH primarily depend on geometrical parameters and do not integrate detailed ultrastructural characteristics, such as cellular components. What is new A novel concept introduces the quantitative measurement of residual photoreceptors located at the edge of FTMH. The Photoreceptor Integrity Index (PIIN) integrates different ultrastructural components of macular holes, aiming to become a valuable clinical tool to predict both anatomical and functional recovery outcomes following surgical intervention for FTMH.

Impact of Aflibercept vs Dexamethasone Treatment on Epiretinal Membrane Formation in Eyes with Diabetic Macular Edema.

This study aimed to investigate the impact of aflibercept and dexamethasone (DEX) on the formation of epiretinal membrane (ERM) and their treatment outcomes in eyes with diabetic macular edema (DME). In this retrospective cohort study, medical records of 124 eyes from 429 patients diagnosed with DME were reviewed between June 2017 and June 2019. Patients were categorized into two groups: the aflibercept group (67 eyes) and the DEX group (57 eyes). The primary endpoint was the secondary ERM incidence following intravitreal treatments and its correlation across different medications. Secondary endpoints included longitudinal changes in best-corrected visual acuity (BCVA) and central macular thickness (CMT). Over a 24-month follow-up, eyes treated with DEX had approximately a fourfold higher incidence of ERM development compared to aflibercept [hazard ratio (HR) = 3.97, p = 0.02]. These eyes also showed worse BCVA (p = 0.059) and increased CMT (p = 0.004), despite requiring fewer total injections (p = 0.000) in the survival analysis model. The cumulative probability of ERM formation was 13.7%. Additionally, DME eyes exhibited poor functional and anatomical outcomes after developing ERM, while age, A1c level, DR severity, initial BCVA and CMT, lens status, and previous laser treatment were not associated with an elevated incidence of ERM formation. Intravitreal DEX implantation in DME eyes resulted in a higher incidence of secondary ERM formation compared to aflibercept over a 2-year period. The therapeutic efficacy for DME was diminished following ERM development, leading to worse anatomical outcomes. New therapeutic approaches should be explored to prevent ERM formation while maintaining both anatomical and functional outcomes in DME treatment.

Long-Term Outcomes of Cataract Surgery: Analysis of Visual Acuity and Intraocular Pressure in a Tertiary Care Center

Abstract: Posterior capsule opacity (PCO) is a common complication following cataract surgery, caused by the proliferation of residual lens epithelial cells. This study aimed to evaluate the long-term effects of Nd:YAG laser capsulotomy on intraocular pressure (IOP) and visual acuity in PCO patients. This was a retrospective descriptive study. Samples were 24 patients diagnosed with PCO who underwent Nd:YAG laser capsulotomy at Prof. Dr. R. D. Kandou Hospital, Manado, from January 1, 2022, to January 1, 2024. The study recorded pre- and post-procedure IOP and best-corrected visual acuity (BCVA) data. Descriptive analysis, including paired t-tests, was used to assess changes in IOP and BCVA over an average follow-up period of 19.2 months. The results showed a statistically significant improvement in BCVA (p=0.000), with mean values improving from 0.72 to 0.27 LogMAR. A significant reduction in IOP was also observed (p=0.015), with long-term IOP remaining stable. A weak correlation was found between follow-up duration and IOP variation (p=0.02). In conclusion, Nd:YAG laser capsulotomy significantly improves visual acuity and stabilizes intraocular pressure in the long term for PCO patients, suggesting its effectiveness in managing post-cataract surgery complications. Keywords: posterior capsule opacity; Nd:YAG laser capsulotomy; intraocular pressure; visual acuity; cataract surgery Methods: A retrospective descriptive study was conducted on 24 patients diagnosed with PCO who underwent Nd capsulotomy at RSUP Prof Dr. R. D. Kandou Central Hospital, Manado, from January 1, 2022, to January 1, 2024. The study recorded pre- and post-procedure IOP and Best-Corrected Visual Acuity (BCVA) data. Descriptive analysis, including paired t-tests, was used to assess changes in IOP and BCVA over an average follow-up period of 19.2 months. Results: The study revealed a statistically significant improvement in BCVA (p = 0.000), with mean values improving from 0.72 to 0.27 LogMAR. A significant reduction in IOP was also observed (p = 0.015), with long-term IOP remaining stable. A weak correlation was found between follow-up duration and IOP variation (p = 0.02). Conclusion: Nd capsulotomy significantly improves visual acuity and stabilizes IOP in the long term for PCO patients, suggesting its effectiveness in managing post-cataract surgery complications.

Baseline optical coherence tomography angiography biomarkers predict visual outcomes in treatment-naïve neovascular age-related macular degeneration patients

This retrospective study aimed to assess different macular neovascular network characteristics in relation to changes in best corrected visual acuity (BCVA) over 3 and 12 months following treatment. Using optical coherence tomography angiography, we reviewed the medical records of 46 treatment-naïve patients with neovascular age-related macular degeneration (nAMD) who received intravitreal aflibercept injections. The change in BCVA from baseline to 3 months and 12 months after treatment was recorded. The mean vessels percentage area, junctions density, lacunarity, and fractal dimension were significantly correlated with the change of BCVA from baseline to month 3 (P = 0.003, 0.046, 0.007, and 0.005 respectively). Fractal dimension and vessels percentage area were correlated with the change of BCVA from baseline to month 12 (P = 0.023 and 0.023 respectively). The findings suggest that baseline characteristics of macular neovascular complexes may serve as predictors for BCVA changes following treatment with aflibercept in nAMD patients.

Dexamethasone implant in naive versus refractory patients with diabetic macular edema: a Meta-analysis.

To evaluate the efficacy and safety of the intravitreal dexamethasone implant in naive and refractory patients with diabetic macular edema (DME). PubMed, Embase, Web of Science, and Medline databases were searched. The main outcomes were best-corrected visual acuity (BCVA) and central retinal thickness (CRT). The secondary outcomes included mean number of injections, intraoperative or postoperative complications including intraocular pressure (IOP) elevation and cataract. Ten comparative studies involving a total of 1000 DME eyes including 402 naive eyes and 598 refractory eyes were selected. The postoperative BCVA in the naive group was significantly better than in the refractory group [mean difference (MD) -0.11, 95% confidence interval (CI) -0.17 to -0.05, P=0.0003; MD 8.69, 95%CI 5.08 to 12.30, P<0.00001)]. Additionally, the naive group got greater improvement of BCVA change as well as more gains of BCVA letters than the refractory group [MD 7.71, 95%CI 2.02 to 13.40, P=0.008; odds ratio (OR) 2.99, 95%CI 2.05 to 4.37, P<0.00001]. The subgroup analysis revealed that the naive group had significantly higher BCVA gains of ≥5, ≥10, and ≥15 letters compared to the refractory group (P=0.002, 0.0001, 0.003, respectively). No significant difference was detected between the two groups in either postoperative CRT (MD -22.36, 95%CI -46.39 to 1.66, P=0.07) or the overall mean number of injections (MD -0.08, 95%CI -0.38 to 0.22, P=0.61). Intraoperative and postoperative complications including the elevation of IOP (OR 0.47, 95%CI 0.20 to 1.13, P=0.09) and cataract (OR 1.78, 95%CI 0.97 to 3.24, P=0.06) showed no significant differences between the two groups during the follow-up time. Intravitreal dexamethasone implants for DME can improve anatomical and functional outcomes in both naive and refractory eyes and have a well-acceptable safety profile. Moreover, naive eyes maintain better visual outcomes than refractory eyes. It provides further evidence of better visual response when used for naive eyes as first-line therapy.

Comparison of Iridex MP3 and P3 probes on long-term intraocular pressure control after MicroPulse Transscleral-Cyclophotocoagulation

PurposeMicropulse transscleral cyclophotocoagulation (MP-TSCPC) is a glaucoma procedure that delivers energy to the ciliary body with minimal collateral-damage. We aim to assess the long-term effectiveness of MP-TSCPC using the original MP3 and revised P3 probe. Methods and designBaseline Retrospective cohort study was performed to obtain baseline characteristics, intraocular pressure (IOP), number of IOP-lowering medications, and best-corrected visual acuity (BCVA) were obtained from pre- and post-operative visits of patients treated with MP-TSCPC. Failure was defined as IOP>21 mmHg, reduced IOP<20% below baseline, or IOP<5 mmHg on 2 consecutive follow-up visits after post-operative month 1, reoperation for glaucoma, or loss of vision to no light perception. ResultsA total of 113 eyes were enrolled, 44 using the MP3 probe and 69 with the revised P3 probe. Survival analysis found a 75% failure rate in patients treated with the revised P3 probe by the final visit with a mean time to failure (MTTF) of 4.8 ± 0.7 months which was higher than the original probe at 66% failure rate with a MTTF of 6.1 ± 1.1 months (p = 0.04). All causes of failure were due to high IOP and 67% required repeat treatment with MP-TSCPC or incisional surgery. Prior to censure of data from failure, both probes had significant reduction in IOP compared to pre-operative IOP at all time points. No significant changes in BCVA were found. Both groups were associated with low rates of complications. ConclusionBoth probes had a very low rate of visually significant complications when performed in a standardized method in accordance with surgical procedure and power settings recommended by Iridex; however, were associated with a high rate of single procedure failure due to uncontrolled IOP over the long term. The revised P3 probe was associated with a higher rate of failure. Patients experienced a reduction in IOP; however, a large proportion required additional treatment compared to the original MP3 probe.

Management of Terson Syndrome: Long-Term Experience in a Single Center.

Terson Syndrome (TS) is a rare entity consisting of an intraocular hemorrhage secondary to subarachnoid hemorrhage (SAH) or intracerebral hemorrhage (IH). This study aimed to retrospectively describe the experience of the Ophthalmology Unit of Policlinico Gemelli, Rome, in the management of TS. Twenty-four eyes of 19 patients (10 males-53%; 9 females-47%; mean age of 44.73 ± 12.49 years) with TS who had pars plana vitrectomy between 2011 and 2024 were included. The primary outcome was the mean change in best-corrected visual acuity (BCVA) 1-3 months after surgery. The secondary outcome was the correlation of post-operative BCVA with the timing of vitrectomy (early vs. late, ≤100 or >100 days). The time between diagnosis and surgery ranged from 33 to 284 days (median = 102 days, interquartile range IQR = 74-161). Baseline BCVA ranged from 6 to 50 ETDRS letters with a median of 17 letters (IQR = 15-25) and significantly increased after surgery, with a median value of 80 (IQR = 70-85). The BCVA percentage improvement had a median of 325% (IQR = 300-431%). No differences in post-operative BCVA were found between patients who underwent early or late vitrectomy. One vitrectomy was complicated by an endophthalmitis. Although no clear guidelines exist on managing TS, vitrectomy significantly improves BCVA, and a delay in surgical intervention does not necessarily worsen the functional outcome. However, an early vitrectomy could improve the stimuli perception, facilitating the rehabilitation process.

Vitrectomy in Small idiopathic MAcuLar hoLe (SMALL) study: Internal limiting membrane peeling versus no peeling.

To compare vitrectomy with and without internal limiting membrane (ILM) peeling in small idiopathic macular holes. Retrospective multicentre study including consecutive eyes with ≤250 μm idiopathic macular hole treated with vitrectomy. The primary outcome was hole closure rate. Best-corrected visual acuity (BCVA) change, closure patterns on optical coherence tomography, rates of external limiting membrane (ELM) and ellipsoid zone (EZ) recovery, and rate of complications were also investigated. In total, 693 eyes were included. Hole closure rate was 98% in the peeling and 85% in the no-peeling group (p < 0.001). At 12 months, mean BCVA change was 0.38 ± 0.22 logMAR in the peeling and 0.45 ± 0.21 logMAR in the no-peeling group (p = 0.02); 66% versus 80% of eyes had a U-shaped morphology, respectively; EZ recovery rate was 75% and 93%, respectively (p = 0.02). In the no-peeling group, eyes with a vitreomacular traction (VMT) showed a 96% closure rate, comparable to the peeling group (p = 0.40). The incidence of adverse events was similar except for dissociated optic nerve fibre layer (55% in the peeling vs. 9% in the no-peeling group, p < 0.001). In small idiopathic macular holes, ILM peeling provides a higher closure rate compared to no-peeling; however, if a VMT is present closure rates are comparable. In closed macular holes, the no-peeling technique provides advantages in terms of visual outcome and anatomical recovery.

Choroidal and Choriocapillaris Changes after Photodynamic Therapy and Subthreshold Micropulse Laser Treatment for Central Serous Chorioretinopathy

Background and Objectives: The aim of the present study is to analyze choroidal and choriocapillaris structural and functional changes in eyes affected by Central serous chorioretinopathy after Photodynamic Therapy (PDT) and Subthreshold Micropulse laser (SML) treatment. Materials and Methods: Forty-two eyes of forty-two patients were analyzed in this observational study. Twenty-four patients underwent SML treatment, whereas eighteen patients were treated with PDT. Examinations were performed at baseline and after 3 months of treatment. Main outcome measures were: Best corrected visual acuity (BCVA), central macular thickness (CMT), central choroidal thickness (CCT), pigment epithelial detachment (PED) presence and maximum height (PEDMH), and choroidal vascularity index (CVI) measured by means of Spectralis HRA + OCT (Heidelberg Engineering, Heidelberg, Germany) Optical coherence tomography (OCT) and choriocapillaris flow voids (CCFV) measured on Optical Coherence Tomography Angiography (OCT-A) platform PLEX Elite 9000 device (Carl Zeiss Meditec Inc., Dublin, CA, USA). Results: Changes in BCVA were registered in both groups over time (p &lt; 0.001). Structural changes in terms of reduced CMT and PED presence were noted in the two groups at follow-up (p &lt; 0.001 and p = 0.001, respectively). Structural and functional choroidal changes were found in the two groups with reduced CCT and CVI over time (p = 0.004 and p = 0.007, respectively), with significant differences between the two groups for CVI parameter (p = 0.001). CCFV increased over time in the PDT group and decreased in the SML group. Conclusions: PDT and SML are effective approaches in CSC eyes and are able to improve structural and functional parameters over time. Choroidal and choriocapillaris parameters are promising biomarkers able to monitor disease course, showing greater impact of PDT on choroid-choriocapillaris complex over time.

Optimization of individualized faricimab dosing for patients with diabetic macular edema: Protocol for the SWAN open-label, single-arm clinical trial.

In patients with diabetic macular edema (DME) from YOSEMITE/RHINE, dual angiopoietin-2/vascular endothelial growth factor-A (VEGF-A) inhibition with faricimab resulted in visual/anatomic improvements with extended dosing. The SWAN trial (jRCTs031230213) will assess the efficacy, durability, and safety of faricimab during the treatment maintenance phase in patients with DME using a treat-and-extend (T&E)-based regimen adapted to clinical practice and the characteristics of patients achieving extended dosing intervals. SWAN is a 2-year, open-label, single-arm, interventional, multicenter trial enrolling adults with center-involving DME. All patients will receive three initial faricimab 6.0 mg doses every 4 weeks (Q4W). From week 12 onwards, in patients without active DME, dosing intervals will be extended in 8-week increments up to Q24W. In contrast, patients with active DME (central subfield thickness [CST] >325 μm and intraretinal fluid [IRF] or subretinal fluid [SRF] resulting in vision loss/disease aggravation) will receive a dose within a day and the dosing interval will be shortened by 4 weeks to a minimum of Q8W relative to the previous dosing interval. Recruitment commenced in August 2023 across a planned 16 sites in Japan. The primary endpoint is change in best-corrected visual acuity (BCVA) from baseline at 1 year (averaged over weeks 52, 56, and 60). Key secondary endpoints include: change from baseline in BCVA, CST, and National Eye Institute Visual Function Questionnaire scores over time; proportion of patients with BCVA (decimal visual acuity) ≥0.5, ≥0.7, ≥1.0, or ≤0.1; proportion of patients with absence of DME, and IRF and/or SRF over time. Safety endpoints include incidence/severity of ocular/nonocular adverse events. The SWAN trial is expected to provide evidence to support individualized faricimab dosing regimens, with the potential to reduce the burden of frequent treatments on patients, caregivers, and healthcare systems.

Treatment of isolated pediatric optic nerve glioma: A nationwide retrospective cohort study and systematic literature review on visual and radiological outcome.

Progressive isolated optic nerve glioma (ONG) in children is a rare disease, treated with various modalities. A global treatment consensus is not available. We conducted a national retrospective multicenter cohort study (1995-2020) to investigate how different treatment strategies impact outcome for ONG in children, by assessing treatment responses to systemic anticancer therapy (SAT), surgery, and radiotherapy for ONG. The primary endpoints included changes in best-corrected visual acuity (BCVA) and tumor volume (TV) on MRI, both evaluated at the start and end of therapy and at long-term follow up. A total of 21 ONGs (20 patients) received SAT (n=14 (66.7%)), surgery (n=4 (19.0%)), and radiotherapy (n=3 (14.3%)). After SAT BCVA stabilized or improved in 66.6% (n=4) and the TV decreased by a median of 45.1% (range: -88.6% to +31.5%) (n=13). Before resection two eyes were already blind. After resection BCVA decreased to blindness in one eye. In total all four eyes were blind after resection. After first-line RT BCVA decreased in 66.7% of ONG to counting fingers or less, TV increased<3 months after RT by a median of 47.3% (range: -42.8% to +245.1%) (n=3), followed by a long-term decrease of 94.4 and 13.8% (n=2), respectively. SAT appears to be the preferred modality for progressive ONG in case of potential rescue of visual functions. Complete resection of ONG appears effective to reduce proptosis in case of preexisting blindness. The use of radiotherapy requires careful consideration due to the risk of severe visual impairment and secondary disease.

IMPACTS OF POSTERIOR STAPHYLOMA ON PARAPAPILLARY MICROVASCULATURE AND ATROPHY IN HIGH MYOPIC EYES: A MATCHED COHORT STUDY WITH OPTICAL COHERENCE TOMOGRAPHY ANGIOGRAPHY.

We aimed to evaluate the impacts of the different types of posterior staphyloma (PS) in high myopia on parapapillary microvasculature and parapapillary atrophy (PPA, i.e., γ-zone and δ-zone) with optical coherence tomography angiography. This cross-sectional study included 152 high myopic eyes (152 participants) with γ-zone. After matching, high myopic eyes were stratified into PS (n = 33) and non-PS (n = 33) groups. PS types, parapapillary microvasculature characteristics, the prevalence of non-juxtapapillary microvasculature dropout (NJ-MvD), the longest radial width from the optic disc edge to retinal pigment epithelium atrophy edge (PPA-w), γ-zone, and δ-zone with changes in visual field and best-corrected visual acuity (BCVA) were evaluated and analyzed. According to Curtin's classification, we identified five types of PS included: primary types I, II, III, and compound types VII, and IX. Eyes with type II showed a higher optic disc tilted ratio and larger PPA-w compared to other primary PS. Subjects with type IX were the oldest. Eyes with types VII and IX had wider γ-zone and δ-zone, worse visual field outcomes, poorer BCVA, and a higher incidence of NJ-MvD compared to primary PS. Choroidal and intrascleral vessels were associated with NJ-MvD and were located near or connected to the circle of Zinn-Haller. Eyes with high myopia and PS show wider PPA, affecting the γ-zone and δ-zone, and are at a higher risk of developing NJ-MvD. Specifically, eyes with PS types VII and IX are more susceptible to visual field damage and decreased BCVA. These results highlight the importance of impact of PS on PPM and PPA in high myopia.

Retinal Fluid and Thickness Fluctuations in Archway Trial for Port Delivery System with Ranibizumab versus Monthly Ranibizumab Injections

PurposeTo determine proportion of eyes with neovascular age-related macular degeneration (nAMD) with retinal fluid and/or central subfield thickness (CST) fluctuations and evaluate their impact on best-corrected visual acuity (BCVA) in eyes treated with the Port Delivery System with ranibizumab (PDS) versus monthly intravitreal ranibizumab injections. DesignPost-hoc analyses of phase 3 Archway trial (NCT03677934). ParticipantsAdults with nAMD responsive to anti-vascular endothelial growth factor therapy. Intervention418 patients randomized 3:2 to the PDS (100 mg/mL) with refill-exchanges every 24 weeks (Q24W) or monthly intravitreal ranibizumab (0.5 mg) for 96 weeks. OutcomesProportion of eyes in each treatment arm with subretinal and/or intraretinal fluid (SRF/IRF) overall and in central 1-mm; BCVA changes from baseline by treatment arm and fluid presence/location; proportion of eyes with CST fluctuations from baseline to week 48, week 48 to 96, and baseline to week 96; effects of CST fluctuations on BCVA. Results415 eyes were assessed. In the PDS versus monthly ranibizumab arm, proportion of eyes with SRF/IRF, central SRF, and central IRF were 47.6% versus 50.9%, 29.0% versus 19.2%, and 11.7% versus 12.6% at baseline, and 57.8% versus 56.1%, 21.6% versus 14.8%, and 7.0% versus 8.4% at week 96. BCVA changes from baseline to week 96 were –1.1 letters with the PDS versus –1.4 with monthly ranibizumab in eyes with SRF/IRF, and –1.9 versus –1.8 in eyes with central SRF. In eyes with central IRF, BCVA changes from baseline to week 96 were –2.1 with the PDS versus –6.9 with monthly ranibizumab, respectively (mean BCVA at 96 weeks 68.9 [20/40] versus 64.6 [20/50]). CST fluctuations occurred in 32.1% and 29.7% of PDS versus monthly ranibizumab eyes; corresponding BCVA changes from baseline to week 96 were –2.5 versus –2.6 (mean BCVA at 96 weeks 72.7 [20/35] versus 71.5 [20/38]). ConclusionsPDS Q24W maintained BCVA to 96 weeks regardless of SRF/IRF, central SRF, central IRF, or CST fluctuations, comparable with monthly ranibizumab, thus supporting the use of the PDS in stabilizing retinal anatomy without the need for monthly treatment in patients with nAMD.

Efficacy and Safety of Ranibizumab Biosimilar QL1205 in Neovascular Age-Related Macular Degeneration: A Phase III Randomized Trial

This study aimed to demonstrate the clinical equivalence of biosimilar QL1205 and reference ranibizumab, Lucentis®, in patients with neovascular age-related macular degeneration (nAMD). This was a multi-center, double-blinded, randomized controlled phase 3 trial. Treatment-naïve patients with active nAMD were randomly assigned to receive QL1205 or reference ranibizumab. Patients received intravitreal injection of QL1205 or reference ranibizumab at a dose of 0.5 mg in the study eye once every four weeks for 48 weeks. The primary endpoint was change in best-corrected visual acuity (BCVA) by Early Treatment Diabetic Retinopathy Study (ETDRS) letters at week 8 compared to baseline level. Biosimilarity of QL1205 to reference ranibizumab was assessed with an equivalence range for the difference in BCVA letters between -3.49 and +3.49. Between June 27, 2019 and June 8, 2021, 616 patients were randomized to the QL1205 group (n=308) and the reference ranibizumab group (n=308). The mean improvement of BCVA was +6.3±9.13 ETDRS letters in the QL1205 group and +7.3±8.82 ETDRS letters in the reference ranibizumab group at week 8. Both the 90% confidence interval (CI) [-2.23, 0.13] and 95% CI [-2.46, 0.36] of the difference between the two treatment groups (P=0.1434) were within the predefined equivalence range. Safety profiles were manageable in both groups. QL1205 was biosimilar to reference ranibizumab regarding clinical efficacy, ocular and systemic safety, as well as immunogenicity and pharmacokinetics profiles in the treatment of patients with nAMD.

Clinical characteristics and long-term treatment outcomes of polypoidal choroidal vasculopathy with classic type leakage

To investigate long-term treatment outcomes of polypoidal choroidal vasculopathy (PCV) with classic type leakage and to compare the outcomes with those of PCV without classic type leakage. This retrospective study included 153 patients diagnosed with PCV and treated with anti-vascular endothelial growth factor (VEGF). Patients showing classic type leakage on fluorescein angiography were included in the classic type leakage group (N = 40, 26.1%), and those without classic type leakage were included in the occult group (N = 113, 73.9%). The best-corrected visual acuity (BCVA) at baseline and 24 months, changes in BCVA, incidence of fibrosis, and lesion reactivation after initial loading injections were compared between the two groups. There was no significant difference in the baseline BCVA between the classic type leakage group (mean logarithm of minimal angle of resolution 0.67 ± 0.53[Snellen equivalents = 20/93]) and the occult group (0.55 ± 0.49[20/70])(P = 0.639). In addition, the BCVA at 24 months (0.44 ± 0.53[20/55] vs. 0.38 ± 0.41[20/47])(P = 1.000), changes in BCVA (0.22 ± 0.42 improvement[2.2 lines] vs. 0.16 ± 0.36 improvement[1.6 lines]) (P = 0.366), and lesion reactivation (P = 0.787) did not differ between the two groups. The incidence of fibrosis was higher in the classic type leakage group (37.5%) than in the occult group (14.2%) (P = 0.002). Although the incidence of fibrosis was higher in PCVs with classic type leakage, the overall treatments were not significantly different between PCVs with and without classic type leakage. In addition, substantial visual improvement was noted at 24 months, suggesting that PCVs with classic type leakage can be effectively treated with anti-VEGF therapy.

The efficacious combined treatment of rhegmatogenous retinal detachment (PVR ≤ C2) with inferior breaks using 25-gauge pars plana vitrectomy and air tamponade.

To examine the surgical results of 25-gauge (25-G) pars plana vitrectomy (PPV) with air tamponade for the repair of primary rhegmatogenous retinal detachment (RRD) with inferior retinal breaks. A retrospective consecutive study was conducted from March 2019 to February 2023 on 27 patients with primary RRD with inferior breaks who underwent 25-G PPV with air tamponade. Once the surgery was completed, the patients were monitored for a minimum of 6 months. Postoperative best-corrected visual acuity (BCVA), postoperative complications, and the rate of single surgery anatomical success were the primary outcome measures. The average age of the 12 female and 15 male study participants was 50.2 ± 12.8 years. The follow-up period was 10.3 ± 3.9 months on average. On average, the affected clock hours were 5.6 ± 2.1 hours, and the average number of retinal breaks was 2.2 ± 1.8. Moreover, the final anatomical success rate was 100%, compared to the estimated initial anatomical success rate of 96.30% following a single surgery. At 6 months, we also noticed a significant change in the mean BCVA, which went from 1.62 ± 0.71 logMAR (preoperative) to 0.89 ± 0.61 logMAR (postoperative) (P < .001). On the first day and the week following surgery, the mean intraocular pressure (IOP) was similar (all P > .05). One patient experienced postoperative complications such as retinal redetachment, which was addressed with the same procedure. After surgery, 2 patients had IOP of 35 and 28 mm Hg for 1 week. Two weeks following surgery, their IOP essentially returned to normal after receiving antihypertensive medication. No other notable postoperative complications were observed. According to this research, 25-G PPV with air tamponade has a satisfactory success rate in repairing primary RRD with inferior breaks. This procedure also produces quicker visual recovery and is linked to fewer complications.