Baseline Best-corrected Visual Acuity Research Articles

Artificial intelligence-based extraction of quantitative ultra-widefield fluorescein angiography parameters in retinal vein occlusion

ObjectiveTo examine the association between quantitative vascular parameters extracted from intravenous fluorescein angiography (IVFA) and baseline clinical characteristics of patients with retinal vein occlusion (RVO). MethodsOur prospective single-centre study in Toronto, Canada, recruited patients with a diagnosis of macular edema secondary to RVO presenting with a central macular thickness (CMT) ≥310 μm from 2017 to 2023. IVFA images were captured using an ultra-widefield scanning laser ophthalmoscope and processed using the artificial intelligence-based RETICAD system to extract quantitative measurements of blood flow, perfusion, and blood–retinal barrier (BRB) permeability. Univariable and multivariable regression models were used to investigate associations between quantitative IVFA parameters and baseline best-corrected visual acuity (BCVA), CMT, and macular volume. ResultsThe study included 41 eyes from 41 RVO patients. In the multivariable analysis, BRB permeability was significantly associated with both CMT (p < 0.001) and macular volume (p = 0.005). Subgroup analyses revealed that in central RVO patients, central BRB permeability remained significantly associated with CMT (p = 0.022) and macular volume (p = 0.010); however, there was no association with BCVA (p = 0.921). In branch RVO patients, central BRB permeability was significantly associated with BCVA (p = 0.006) and CMT (p = 0.009), but not with macular volume (p = 0.723). Additionally, both central and peripheral BRB permeability were significantly higher in patients with RVO compared to healthy controls (p < 0.001). ConclusionsOur investigation reveals novel associations between baseline clinical characteristics and quantitative IVFA parameters in RVO patients, which may serve as clinically relevant biomarkers. Future studies should explore these associations in diverse RVO patient populations with extended follow-up.

Interim Results of the Phase III Portal Extension Trial of the Port Delivery System with Ranibizumab in Neovascular Age-Related Macular Degeneration

ObjectiveThe Port Delivery System with ranibizumab (PDS) is approved in the United States for neovascular age-related macular degeneration (nAMD). Portal (NCT03683251) is evaluating long-term safety and tolerability of the PDS in patients with nAMD who completed the phase II Ladder (NCT02510794) or phase III Archway (NCT03677934) trials. DesignMulticenter, nonrandomized, open-label, extension clinical trial. ParticipantsAll-PDS safety population (N = 555) comprises patients enrolled in Portal who completed Ladder or Archway. Due to data availability, efficacy population comprises Ladder-to-Portal patients only: patients who previously received PDS 10, 40, or 100 mg/ml pro re nata (as-needed [PRN]; n = 58, 62, 59, respectively) or monthly intravitreal ranibizumab 0.5-mg injections (monthly ranibizumab; n = 41) in Ladder and subsequently enrolled in Portal. MethodsLadder patients received PDS refill-exchanges PRN or monthly ranibizumab. Archway patients received PDS 100 mg/ml with fixed refill-exchanges every 24 weeks (PDS Q24W) or monthly ranibizumab. Once enrolled in Portal, all patients receive PDS Q24W from day 1. Main Outcome MeasuresOcular adverse events of special interest (AESIs); changes from baseline in best-corrected visual acuity (BCVA) and center point thickness (CPT); supplemental ranibizumab treatment between refill-exchange procedures; PDS Patient Preference Questionnaire results. ResultsIn the All-PDS safety population (mean follow-up, 111 weeks), 137 (24.7%) patients had ≥ 1 ocular AESI; most common were cataract (11.4%), vitreous hemorrhage (6.1%), conjunctival thickening (bleb)/filtering bleb leak (6.3%). Endophthalmitis occurred in 11 of 555 (2.0%) patients. For Ladder-to-Portal patients previously treated with PDS 100 mg/ml or monthly ranibizumab, BCVA remained stable from baseline to month 48; mean (95% confidence interval) changes from baseline were 0.1 (−6.6, 6.8; n = 31) and 2.3 (−9.4, 14.1; n = 15) letters, respectively; CPT remained stable through month 48. Approximately 95% of patients did not need supplemental treatment before each refill-exchange for > 2 years since Portal enrollment. Of Ladder-to-Portal previous monthly ranibizumab patients, 92% preferred the PDS over injections. ConclusionsInterim results from Portal suggest 4-year maintenance of visual/anatomic outcomes with PDS 100 mg/ml, with the PDS preferred to monthly injections. Long-term safety profile of the PDS is well characterized.

XOLARIS: A 24-Month, Prospective, Natural History Study of 201 Participants with Retinitis Pigmentosa GTPase Regulator-Associated X-Linked Retinitis Pigmentosa

ObjectiveTo improve the understanding of the natural disease progression of retinitis pigmentosa GTPase regulator (RPGR)-associated X-linked retinitis pigmentosa (XLRP). DesignA multicenter, prospective, observational natural history study over 24 months. ParticipantsMale participants aged ≥7 years with a pathogenic variant in the RPGR gene, a best-corrected visual acuity (BCVA) score of ≥34 Early Treatment Diabetic Retinopathy Study (ETDRS) letters, and a mean 68-loci retinal sensitivity (assessed by microperimetry) of 0.1–20 decibels (dB). MethodsParticipants were divided into subgroups based on their BCVA score at baseline: 34–73 (lower BCVA) or ≥74 (higher BCVA) ETDRS letters. There were 7 visits over 24 months. Main Outcome MeasuresChange from baseline in BCVA, retinal sensitivity, low luminance visual acuity (LLVA), fixation stability, contrast sensitivity, visual field, anatomical measures, 25-item Visual Function Questionnaire (VFQ-25), intraocular pressure, and adverse events (AEs). ResultsOverall, 201 participants were included. The mean (standard deviation [SD]) age was 30.3 (11.9) years in the lower BCVA subgroup (n=170) and 27.7 (10.1) years in the higher BCVA subgroup (n=31). The study eye baseline mean (SD) BCVA scores were 59.4 (10.30) and 77.3 (3.95) in the lower and higher BCVA subgroups, respectively; the lower BCVA subgroup had lower retinal sensitivity in the study eye at baseline than the higher BCVA subgroup. Over 24 months, there were small observed changes in BCVA, retinal sensitivity, LLVA, fixation, contrast sensitivity, and fundus photography findings. There were observed mean (SD) changes at 24 months in the lower and higher BCVA subgroups of −1.01 (4.67) and 0.03 (5.83) dB-steradians in the volume of full-field hill of vision, −330.6 (869.51) and −122.7 (22.01) μm in distance from foveal center to the nearest border of preserved fundus autofluorescence, −104.3 (277.80) and −207.1 (171.01) μm in central ellipsoid width, and −2.8 (9.7) and −0.6 (7.6) in VFQ-25 composite score, respectively. There was 1 death from completed suicide. There were no ocular serious AEs, and most AEs were mild/moderate. ConclusionsThis study provides evidence of the slow natural progression of XLRP over 24 months in both subgroups and provides important functional, anatomical, and safety data.

Central Retinal Thickness Variability as a Predictive Factor for Visual Acuity After Dexamethasone Implant in Retinal Vein Occlusion.

Investigate central retinal thickness (CRT) variability and changes in best-corrected visual acuity (BCVA) after 12 months in patients with retinal vein occlusion (RVO) treated with dexamethasone intravitreal implants. Post hoc analyses of two randomized trials in patients with macular edema associated with branch or central RVO treated with a 0.7-mg dexamethasone implant. Central retinal thickness standard deviation (CRT-SD) and central retinal thickness amplitude (CRT-A) were measures of variability. Analyses included multinomial and simple linear regression. In 400 patients, CRT-SD and CRT-A were significantly associated with central RVO, second dexamethasone implant, and baseline CRT. Baseline BCVA was associated with CRT-A. CRT-SD and CRT-A were significantly correlated with a 12-month change in BCVA (effect sizes of -0.032 and -0.013 letters/µm; P < 0.001). Patients in the highest CRT-SD quartile gained significantly fewer letters (+1.88 letters; 95% CI: -0.46 to 4.23). Greater CRT variability was associated with smaller BCVA improvements in patients with RVO treated with dexamethasone implants. [Ophthalmic Surg Lasers Imaging Retina 2024;55:XX-XX.].

Short-Term Clinical Outcomes of Patients with Diabetic Macular Edema Following a Therapy Switch to Faricimab.

Background: With this study, we investigate the short-term clinical outcomes of patients affected by diabetic macular edema (DME) after switching to intravitreal Faricimab (IVF) in a real-world setting. Methods: We conducted a retrospective chart review on all patients treated for DME with IVF who showed insufficient responses to prior anti-VEGF therapy. Data collected included baseline patient demographics, medical history, best-corrected visual acuity (BCVA), central retinal thickness (CRT) and central retinal volume (CRV). We analyzed functional and structural measures before and after IVF, compared baseline demographics and treatment factors between Faricimab-responders and reduced-responders and assessed influencing factors of the follow-up BCVA and CRT. Results: This study included 25 eyes from 16 patients. After switching to IVF, the mean BCVA showed no significant improvement, changing from 59.4 ± 13.4 Early Treatment of Diabetic Retinopathy Study (ETDRS) letters at baseline to 61.4 ± 12.8 ETDRS letters at follow-up (p = 0.26). CRT significantly reduced from 414.4 ± 126.3 µm to 353.3 ± 131.1 µm (p < 0.011), and the 3 mm CRV significantly decreased from 2.8 ± 0.5 mm3 to 2.6 ± 0.6 mm3 (p < 0.012). Seven patients met the responder criteria, exhibiting an improvement of at least 5 ETDRS letters and a simultaneous CRT reduction of at least 30 µm. Further analysis showed that higher BCVA at baseline (p < 0.001) was associated with better BCVA following IVF, while higher baseline CRT (p < 0.003), a higher number of prior anti-VEGF agents (p < 0.034) and prior corticosteroid injections (p < 0.019) were associated with greater CRT at follow-up. Conclusions: Following the initial IVF injection series, we observed a clear improvement of anatomical measures. No functional improvement was observed, although visual acuity remained stable. Higher baseline BCVA was associated with better post-IVF BCVA, while higher baseline CRT, a greater number of prior anti-VEGF agents and prior corticosteroid injections were linked to higher CRT post-IVF.

Clinical characteristics, predisposing factors, and management of moraxella keratitis in a tertiary eye hospital

PurposeThe Moraxella species is a very uncommon pathogen that leads to microbial keratitis (MK). This study aimed to evaluate the clinical features, predisposing factors, and outcomes of Moraxella keratitis in patients of a tertiary eye hospital.MethodsThis retrospective study was conducted from 2015 to 2022, on patients who were admitted with the diagnosis of Moraxella keratitis confirmed by positive culture in a referral eye hospital. Demographics, predisposing factors, best-corrected visual acuity (BCVA), and prognosis were assessed.ResultsA total of 106 individuals diagnosed with Moraxella keratitis, were analyzed. The mean age was 54.42 ± 19.43 years. The mean baseline BCVA of the patients was 2.28 ± 0.6 LogMAR, while this amount reached 1.49 ± 0.81 in the 6-month follow-up (P-value = 0.02). The mean BCVA in the six-month follow-up of the patients who needed surgical interventions was significantly lower than the patients who received only medical treatment (2.15 ± 0.65 vs. 1.29 ± 0.75 LogMAR, P-value = 0.02). Patients with diabetes and those without diabetes did not substantially vary in the prevalence of corneal perforation (P-value = 0.515). Three predisposing factors including corneal perforation (odds ratio = 19.27, P-value = 0.001), hypertension (HTN) (odds ratio = 3.62, P-value = 0.03), and older age (odds ratio = 1.03, P-value = 0.008) were significantly associated with more need for surgical interventions.ConclusionIn this cohort, poor prognosis necessitating surgical interventions in Moraxella keratitis was found to be associated with corneal perforation, HTN, and older age.

Skeleton density and ellipsoid zone loss are prognostic for progression in Macular Telangiectasia Type 2

Macular Telangiectasia Type 2 (MacTel) is a chronic, progressive disease of the central retina characterized by vascular and neurodegenerative changes. As there is currently no treatment for non-neovascular MacTel, there is a dearth for biomarkers identifying eyes with an increased risk for disease progression for patient counseling and clinical trial recruitment. Eyes were classified to be stable or progressive, defined by the fundus photography-based grading system by Gass and Blodi. First, structural differences between these two groups were assessed, employing optical coherence tomography (OCT) and OCT-angiography. Univariate regression analyses revealed evidence towards a lower superficial retinal layer (SRL) vessel density (VD), skeleton density (SD) and deep retinal layer (DRL) SD in progressing compared to stable eyes (p = 0.05, p = 0.05, p = 0.07). Second, a multivariable predictive model was employed to examine the predictive value of structural and functional parameters for disease progression. Baseline best corrected visual acuity (BCVA) and SRL SD are prognostic for disease progression (p < 0.001, p = 0.05). The presence of ellipsoid zone (EZ) loss is prognostic for future central retinal thickness (p < 0.01). We propose SRL SD, BCVA, and EZ loss as prognostic biomarkers and as possible outcome measures in future interventional studies in MacTel.

Pneumatic retinopexy for primary rhegmatogenous retinal detachment: from a clinical trial to the real-life experience

BackgroundTo report real-world outcomes of patients with primary Reghmatogenous Retinal Detachment (RRD) treated with Pneumatic Retinopexy (PnR) according to the indications of the Pneumatic Retinopexy versus Vitrectomy for management of Primary Rhegmatogenous Retinal Detachment Outcomes Randomized Trial (PIVOT) trial.MethodsMulticenter, retrospective study. Patients treated with PnR for RRD between 2021 and 2023 and a follow-up of at least 6 months were included. Single-procedure anatomical success, final anatomical success, complications, causes of failures, best corrected visual acuity (BCVA) after surgery, and the vision-related quality of life using the 25-Item National Eye Institute Visual Function Questionnaire (NEI VFQ-25) were reported.ResultsA total of 76 eyes of 76 patients were included. Mean age was 60 ± 8.1 years. Primary anatomic reattachment was achieved by 84.3% of patients and final anatomical reattachment after pars plana vitrectomy was obtained in 100% of patients. BCVA improved from 0.32 (20/40) to 0.04 (20/20) logMar (p < 0.001) at 6 months. The main cause of failure was related to the presence of additional (likely missed) retinal breaks (66.6% of cases). Also, primary PnR failure was more frequent in eyes of patients with older age, macular involvement, worse baseline BCVA, greater extent of the RRD, and increased duration from diagnosis to treatment. Overall, the mean NEI-VFQ 25 composite score was 93.9% ± 6.4 at 6 months.ConclusionsThe criteria of the PIVOT trial can be applied to real-world scenarios in the decision-making process for the treatment of primary RRD, with excellent anatomical and functional outcomes.

Morphological Change in Optical Coherence Tomography and Functional Outcomes in Epiretinal Membrane Peeling with or without SF6 Tamponade.

The present study compares the anatomical and functional outcomes (best-corrected visual acuity (BCVA) and central macular thickness (CMT)) among membrane peeling with or without SF6 tamponade in patients with epiretinal membrane. We retrospectively reviewed patients diagnosed with macular pucker who underwent pars plana vitrectomy and membrane peeling in a tertiary center in Taiwan from January 2021 to December 2022. Subjects were categorized into with or without SF6 tamponade groups (SF6 group and BSS group). Postoperative intraocular pressure and complications were documented. Logistic regression analyses were performed to identify the prognostic factors during follow-up. A total of 89 eyes were enrolled, including 34 eyes in the BSS group and 55 eyes in the SF6 group. The mean age was 66 years old, and a female predilection was demonstrated. Both groups possessed statistically significant improvement in BCVA and CMT after the operation. There was no significant difference in CMT between the groups at any time of observation, yet we observed significant differences in baseline BCVA and BCVA at last follow-up among the two groups. Both groups yielded an approximate enhancement of LogMAR 0.3 in BCVA postoperatively. There was no significant difference noted in postoperative IOP between the two groups. Membrane peeling with or without SF6 tamponade yields comparable outcomes anatomically and functionally. This may indicate that SF6 tamponade for idiopathic macular pucker surgery may not provide extra benefit, and therefore warrants reconsideration as standard procedure.

Effectiveness of Suprachoroidal Injection of Triamcinolone Acetonide in Diabetic Macular Edema Following Pars Plana Vitrectomy Using a Modified Custom Microneedle.

The present study evaluated the efficacy of suprachoroidal injection of Triamcinolone Acetonide (SCTA) in diabetic macular edema (DME) following pars plana vitrectomy (PPV) using a modified microneedle. A prospective interventional study was conducted on 60 eyes of 60 patients with centrally involved diabetic macular edema following pars plana vitrectomy (PPV). SCTA was performed at the baseline and repeated after 3 months in case of persistent subretinal or intraretinal fluid, central macular thickness (CMT) more than 300 µm or visual loss by more than one line of the Snellen chart. The present study detected significant reduction of the CMT from 498.3 ± 94.8 µm at the baseline to 212.3 ± 11.9 µm after 12 months of injection with p < 0.001 and a significant improvement of best corrected visual acuity (BCVA) from 1 (0.9-1.2) at the baseline to 0.5 (0.3-0.7) after 12 months of injection with p < 0.001. The intraocular pressure (IOP) increased significantly after 3 months of injection with p < 0.001 and then gradually declined to its normal level after 6 months. Inner segment/outer segment (IS/OS) disruption was the only significant predictor of the final CMT; however, the number of injections, IS/OS disruption, baseline BCVA and the HbA1C level were the significant predictors of the final BCVA after injection. Suprachoroidal injection of TA using this microneedle resulted in significant anatomical and functional improvement in previously vitrectomized diabetic macular edema patients with no recorded ocular or systemic adverse events.

Intra-operative Intravitreal Bevacizumab For Patients With Diabetic Macular Edema Undergoing Phacoemulsification with Foldable IOL Implantation

Objective: To assess the efficacy of Intra-operative Intravitreal Bevacizumab in treating Diabetic Macular Edema in patients undergoing Phacoemulsification with Foldable intraocular lens (IOL) Implantation, in comparison to a control group.Methodology: This experimental study was performed in department of Ophthalmology, Madinah Teaching Hospital, Faisalabad from 5th October to 2022 – 5th March 2023. Sixty patients (30 in each group) were enrolled in the study. Patients in group “A” received Intravitreal Bevacizumab immediately after phacoemulsification with foldable IOL implantation.Whereas Intravitreal Bevacizumab was not given to patients in group B (control group). Best Corrected Visual Acuity (BCVA) and macular thickness using optical coherence tomography (OCT) were recorded within a timeframe of 7-30 days prior to surgery, as well as at 1 and 3 months after the surgery for comparison between the two study groups. Results: The study comprised 60 patients, with a mean age of 56.43 ± 5.90 years, representing both genders. Among the participants, males were predominant, accounting for 32 (53.3%) individuals, while females constituted 28 (46.7%) of the sample. The baseline best-corrected visual acuity (BCVA) measurements between group A and group B were 0.22 ± 0.68 and 0.21 ± 0.07, respectively. There was no statistically significant difference observed between the two groups (P = 0.677). However, significant disparities in BCVA were observed after one- and three-months post-surgery, favoring group A.Similarly, mean optical coherence tomography (OCT) at baseline was 271.09 ± 26.87 in group A and 307.57 ± 32.81 in group B, with no significant difference (P = 0.771). Nonetheless, significant differences in OCT were noted after one- and three-months post-surgery, with group A demonstrating superior results. These findings underscore the beneficial impact of intra-operative Bevacizumab in improving both BCVA and OCT outcomes post-surgery. Conclusion: The administration of intravitreal bevacizumab during phacoemulsification has been shown to yield notable improvements in Best Corrected Visual Acuity (BVCA) and Optical Coherence Tomography (OCT) among those with diabetes with macular edema who are undergoing cataract surgery.

Aflibercept 8 mg/0.07 mL (Eylea HD)

CADTH recommends that Eylea HD should be reimbursed by public drug plans for the treatment of neovascular (wet) age-related macular degeneration (nAMD) if certain conditions are met. Eylea HD should only be reimbursed for adults who have not previously been treated with an anti–vascular endothelial growth factor (VEGF) drug for their nAMD, have a baseline best-corrected visual acuity score between 78 to 24 letters based on the Early Treatment Diabetic Retinopathy Study (ETDRS) scoring system, more than 50% of the newly formed abnormal blood vessels originate from the choroid layer of the eye, and imaging shows there is fluid buildup affecting the centre of the eye. Eylea HD should only be reimbursed if it is prescribed by an ophthalmologist with experience managing nAMD, it is not used in combination with other anti-VEGF drugs, and the cost of Eylea HD is not more than the least costly anti-VEGF drug covered by the public drug plans for the treatment of nAMD. Eylea HD should only be authorized for reimbursement for 12 months the first time it is used. Eylea HD should not continue to be reimbursed if injections need to be given more frequently than every 12 weeks or if the patient’s vision worsens by at least 5 letters due to their nAMD persisting or worsening and their central retina thickens by greater than 25 μm, new abnormal blood vessels form, or there is bleeding in the part of the eye responsible for central vision.

Comparison of the therapeutic effects of photodynamic therapy, transpupillary thermotherapy, and their combination on circumscribed choroidal haemangioma

ObjectiveTo characterize the clinical and imaging features of circumscribed choroidal hemangioma (CCH), and to evaluate individualized treatment efficiency of photodynamic therapy (PDT), transpupillary thermotherapy (TTT), or their combination, followed by retrobulbar injection of betamethasone on CCH resolvement. MethodsForty-nine patients with CCHs who underwent PDT, TTT or PDT+TTT treatments were retrospectively analyzed. Their treatment efficacy was compared by analyzing the change of best corrected visual acuity (BCVA), subretinal fluid (SRF) and CCH lesion characteristics. ResultsPDT, TTT and PDT+TTT were respectively administrated in 17, 11 and 21 patients. No significant difference in age, gender, affected eyes and tumor location across the three groups. Baseline BCVA were 0.41 ± 0.28, 0.62 ± 0.30 and 0.24 ± 0.24 for PDT, TTT and PDT+TTT groups, respectively (F = 6.572, P = 0.003). CCH treated by three strategies showed significant difference in maximum tumor basal diameter, SRF areas and macula involvement prior to the treatment (P < 0.05). Patients receiving PDT+TTT exhibited larger tumor basal diameter, more SRF, higher ratio of macular involvement than other groups. A total of 38 (77.6 %) cases had good visual acidity with final BCVA ≥0.5 after treatments. PDT and PDT+TTT treatment groups acquired more vision improvement (0.27 ± 0.23 and 0.31 ± 0.26) in BCVA than TTT group (0.09 ± 0.13). All SRF were resolved within two weeks of treatment and no recurrent SRF were found. ConclusionThe three treatments showed good performance in improving visual function and controlling SRF, and individualized treatment should be selected primarily by the tumor location, and then the tumor size and presence of SRF.

Differences between pathologic and non-pathologic high myopia in 4-year outcomes of anti-VEGF therapy for macular neovascularization

This retrospective observational study aimed to investigate the difference in 4-year outcomes of ranibizumab or aflibercept therapy for macular neovascularization (MNV) with high myopia between pathologic myopia (PM) and non-PM. This study was conducted at Kyoto University Hospital and included consecutive treatment-naïve eyes with active myopic MNV, in which a single intravitreal ranibizumab or aflibercept injection was administered, followed by a pro re nata (PRN) regimen for 4 years. Based on the META-PM study classification, eyes were assigned to the non-PM and PM groups. This study analyzed 118 eyes of 118 patients (non-PM group, 19 eyes; PM group, 99 eyes). Baseline, 1-year, and 2-year best-corrected visual acuity (BCVA) were significantly better in the non-PM group (P = 0.02, 0.01, and 0.02, respectively); however, the 3-year and 4-year BCVA were not. The 4-year BCVA course was similar in both groups. However, the total number of injections over 4 years was significantly higher in the non-PM than in the PM group (4.6 ± 2.6 vs. 2.9 ± 2.6, P = 0.001). Four-year BCVA significantly correlated only with baseline BCVA in both non-PM (P = 0.047, β = 0.46) and PM groups (P < 0.001, β = 0.59). In conclusion, over the 4-year observation period, the BCVA course after anti-VEGF therapy for myopic MNV was similar in the eyes with non-PM and those with PM; however, more additional injections in a PRN regimen were required in the eyes with non-PM compared to those with PM. Thus, more frequent and careful follow-up is required for the eyes with non-PM compared with those with PM to maintain long-term BCVA.

Efficacy of Faricimab versus Aflibercept in Diabetic Macular Edema in the 20/50 or Worse Vision Subgroup in Phase III YOSEMITE and RHINE Trials

PurposeDRCR.net Protocol T data suggest the response to treatment among patients with diabetic macular edema (DME) may vary depending on baseline best-corrected visual acuity (BCVA). We evaluated the efficacy of faricimab 6 mg versus aflibercept 2 mg over 2 years in patients with DME enrolled in faricimab phase 3 trials with baseline Early Treatment Diabetic Retinopathy Study (ETDRS) BCVA ≤20/50. DesignYOSEMITE/RHINE were identically designed, multicenter, randomized, double-masked, active comparator–controlled, noninferiority trials. ParticipantsAdults aged ≥18 years with center-involving macular edema secondary to type 1 or 2 diabetes. MethodsPatients were randomized to faricimab every 8 weeks (Q8W), faricimab per a personalized treat-and-extend–based regimen (T&E), or aflibercept Q8W. Post hoc subgroup analyses were conducted using the intent-to-treat population with baseline BCVA ≤20/50 (ETDRS letters <69). Main Outcome MeasuresChanges in ETDRS BCVA and central subfield thickness (CST) from baseline to years 1 and 2 were compared between treatment arms using mixed-model repeated measures analyses. ResultsIn YOSEMITE/RHINE, 220/217 patients in the faricimab Q8W; 220/219, faricimab T&E; and 219/214, aflibercept Q8W arms had baseline BCVA ≤20/50. In both trials, mean change in ETDRS BCVA was comparable between treatments at years 1 and 2. In YOSEMITE, adjusted mean (95% CI) change from baseline in CST (μm) at year 1 was greater with faricimab Q8W (–232.8 [–243.5, –222.1]) and faricimab T&E (–217.4 [–227.9, –206.9]) versus aflibercept Q8W (–190.4 [–200.9, –179.8]; P<0.0001 and P=0.0004, respectively). The pattern was similar in RHINE: faricimab Q8W, –214.2 (–225.3, –203.1); faricimab T&E, –206.6 (–217.4, –195.7); aflibercept Q8W, –186.6 (–197.7, –175.5); P=0.0006 and P=0.0116 for faricimab arms versus aflibercept, respectively. In both trials, change from baseline in CST at year 2 was greater with faricimab Q8W versus aflibercept. Median time to first CST <325 μm and first absence of intraretinal fluid was shorter in the faricimab arms versus aflibercept, with fewer injections on average. ConclusionsIn patients with DME and baseline ETDRS BCVA ≤20/50, faricimab treatment resulted in comparable visual acuity, greater reduction in retinal thickness, and fewer injections compared with aflibercept over 2 years of treatment.

Duration after Macular Hole Surgery for Stabilisation of Visual Acuity: A Long-term Retrospective Review

The purpose of the study is to determine the median duration for visual recovery to achieve visual stability and visual acuity gain after macular hole surgery in our local population. This was a retrospective study. Patients with full-thickness macular holes (FTMH) from surgical logs were included between January 2009 and December 2019. The patients' medical records were reviewed for pre-, intra-, and post-operative data collection. Patients who fulfilled the inclusion and exclusion criteria were recruited and analysed. Data collected from the medical record pre-operatively, which included baseline best corrected visual acuity (BCVA), interval of symptoms development to surgery, any ocular co-morbidities, optical coherence tomography (OCT) for size and stage of macular hole and central subfield thickness (CST). Intra-operative notes included whether vitrectomy with or without phacoemulsification and with the internal limiting membrane (ILM) peel or ILM flaps, types of dye, and tamponade agent used. Post-operative data included BCVA and CST on each visit, types of macular hole closure, or any complications. Data were analysed using SPSS.Thirty-one patients were diagnosed with FTMH. Sixteen patients who underwent pars plana vitrectomy (PPV) were included and analysed. Fifteen patients (93.75%) achieved successful macular hole closure after the primary operation. The median duration BCVA reached at stability was 19.5 months (IQR 9 – 26.25), and visual acuity gained by 0.44 LogMAR (IQR 0.165 – 0.565). Ten patients (62.5%) underwent combined PPV with phacoemulsification. CST showed improvement from baseline, 444 (IQR 347.5 – 519.75) to 273 (IQR 232 -285.5), 230 (IQR 221.5-255), and 270 (IQR 254-322) at the period interval of 0 to 3 months, 3 to 6 months, and 6 to 12 months respectively. Gas C3F8 and membrane blue were commonly used as tamponade agents and dyes, and PPV with ILM peel was the common surgery performed. Six patients (40%) achieved type 1 macular hole closure within 12 months of follow-up. Despite the small sample size, our study provided practical information regarding patient’s expectations of when their vision can become stable after macula hole surgery in our local population.

Comparative study on the efficacy of Conbercept and Aflibercept in the treatment of neovascular age-related macular degeneration

This study compares the effectiveness of Conbercept and Aflibercept in treating neovascular age-related macular degeneration (nAMD). Conducted at the First Affiliated Hospital of Chongqing Medical University's Ophthalmology Department (May 2020–May 2023), this prospective study enrolled 159 nAMD patients. Participants were randomly divided into two groups: one receiving 0.5 mg Conbercept and the other 2 mg Aflibercept intravitreal injections. Over 12 months, the study, employing a Treat-and-Extend (T&E) regimen, assessed Best-Corrected Visual Acuity (BCVA), Central Retinal Thickness (CRT) changes and injection frequency. Of the 159 patients, 137 (149 eyes) completed the study. No significant age difference was found between the groups (P = 0.331). After 12 months, BCVA improved similarly in both groups (Conbercept: 52.8 ± 18.9, Aflibercept: 52.0 ± 19.7 letters; P = 0.820). CRT reduction was also comparable (Conbercept: 246.3 ± 82.8 µm, Aflibercept: 275.9 ± 114.3 µm; P = 0.079). Injection frequencies averaged 6.9 ± 0.7 (Conbercept) and 6.7 ± 0.7 (Aflibercept; P = 0.255). Subtype analysis revealed Type 1 MNV had higher baseline BCVA and lower CRT, with more frequent injections compared to other types. Both Conbercept and Aflibercept are clinically similar in efficacy for nAMD, with the T&E regimen proving therapeutically effective and potentially reducing patient costs. Anti-VEGF treatment efficacy varies across nAMD subtypes, indicating a potential benefit in tailored treatments for specific subtypes.Clinical trial registration number NCT05539235 (Protocol Registration and Results System).

Factors affecting anatomical and visual outcomes in Terson syndrome managed by surgery or observation.

To investigate visual outcomes and prognostic factors of patients with Terson syndrome (TS) managed with observation or pars plana vitrectomy (PPV). retrospective review of medical records of 117 eyes from 81 patients (43 females) with TS. Main outcome measures were final best corrected visual acuity (BCVA), intraoperative findings and long-term sequelae. 46 (39.3%) eyes were managed conservatively and 71 (60.7%) eyes underwent PPV. Median follow-up was 8.4 months. The PPV group had significantly worse (p < 0.001) baseline BCVA (median 2.3 versus 0.7 logMAR, Snellen equivalent 20/4000 versus 20/100). Final BCVA did not differ between the two groups (p = 0.38). Final BCVA ≥ 0.3 logMAR (20/40) in the surgery group was associated with post-operative retinal detachment (p = 0.013) and macular abnormalities (p = 0.014), and in the observation group with ocular comorbidity (p = 0.008). Retinal breaks were detected intraoperatively in 25 (35.2%) eyes and were associated with an interval longer than 3 months between ocular diagnosis and surgery (p = 0.04), but not with larger gauge instrumentation and posterior vitreous detachment. Incidence of ERM did not differ among patients managed conservatively and after PPV (p = 0.9) and between eyes undergoing early or delayed surgery (p = 0.09). The most common post-operative complications were cataract in 16 (22.5%) eyes and ERM in 8 (11.3%) eyes. visual outcomes in TS are similar with both management strategies. Surgery allows faster and greater visual recovery but carries high risk of intraoperative retinal tears if delayed for longer than 3 months from initial presentation. ERM and retinal detachment are not correlated with timing of surgery or management strategy.

Association of baseline factors with 1-year outcomes in the SB11-ranibizumab equivalence trial: A post hoc analysis

PurposeTo identify baseline factors associated with 1-year outcomes when treating neovascular age-related macular degeneration (nAMD) with ranibizumab biosimilar SB11 or reference ranibizumab (rRBZ), and to compare efficacy of the two products within subgroups judged to be clinically relevant. DesignPost hoc analysis of a prospective, equivalence phase 3 randomized clinical trial (RCT) Methods705 patients with nAMD were randomized 1:1 to receive SB11 or rRBZ for 48 weeks. Pooled and randomized groups were used to identify baseline factors associated with clinical outcomes at Week 52 using multiple linear regression models. Significant factors identified in regression analyses were confirmed in analyses of variance. Subgroup analyses comparing best-corrected visual acuity (BCVA) changes between SB11 and rRBZ were conducted. Results634 (89.9%) participants completed the 52-week visit. Regression analyses showed that younger age, lower BCVA, and smaller total lesion area at baseline were associated with greater BCVA gain at Week 52, while older age, lower BCVA, and thicker central subfield thickness (CST) at baseline were predictors of greater CST reduction in the pooled group. Subgroup analyses demonstrated that BCVA outcomes appeared comparable for the SB11 and rRBZ groups. ConclusionPost hoc analyses of the SB11-rRBZ equivalence study showed that baseline age, BCVA, CST, and total lesion area were prognostic factors for visual or anatomical outcomes of nAMD, while subgroup analyses demonstrated comparable results for SB11 and rRBZ. Collectively, the results appear comparable to similar RCTs of anti-vascular endothelial growth factor reference products for nAMD and strengthen confidence in the biosimilarity of SB11.

Six-month results of 577 nm subthreshold micropulse laser therapy in non-center involving diabetic macular edema

BackgroundThis study aimed to evaluate the efficacy of 577 nm subthreshold micropulse laser (SML) therapy in patients with non-center involving diabetic macular edema (DME). MethodsTwenty-two eyes of 18 patients diagnosed with non-center involving DME were included in this prospective, observational study. The patient's baseline best corrected visual acuity (BCVA), maximum retinal thickness (MRT), central macular thickness (CMT), and the area of macular exudates were determined and re-evaluated at 1, 3, and 6 months after laser treatment. ResultsThere was no statistically significant change in BCVA at the 1st, 3rd and 6th months compared to the baseline in the follow-up (p = 0.067, p = 0.270, p = 0.027 according to Bonferroni correction p < 0,01). 1st, 3rd, and 6th month MRT was statistically significantly lower than baseline (p = 0,009, p = 0,006, p = 0,007). No statistically significant change was detected in CMT at the 1st, 3rd and 6th months compared to the baseline in the follow-up (p = 0.384, p = 0.794, p = 0.363). No statistically significant change in the area of macular exudates was detected at the 1st, 3rd, and 6th months compared to the baseline (p = 0.904, p = 0.444, p = 0.277). ConclusionsThis study observed a significant decrease in extrafoveal retinal thickness in patients with DME. There was no progression to central macular involvement, an increase in the area of exudates, and a decrease in BCVA in any patient. SML may be an effective alternative to conventional argon laser in non-center involving DME.