Canadian journal of ophthalmology. Journal canadien d'ophtalmologie最新文献

Objective: To evaluate the postmarketing ocular adverse events (AEs) reported for intravitreal antivascular endothelial growth factor (anti-VEGF) therapies, aflibercept (2 mg and 8 mg), and faricimab (6 mg).

Design: Retrospective pharmacovigilance analysis.

Participants: Food and Drug Administration Adverse Event Reporting System (FAERS) database.

Methods: We conducted a retrospective pharmacovigilance analysis of the FAERS database from the fourth quarter of 2023 to the first quarter of 2025. Descriptive statistics and reporting odds ratio (ROR) analysis were employed to evaluate and compare AEs between 2 mg aflibercept, 8 mg aflibercept, and faricimab.

Results: A total of 462 unique reports of AEs secondary to 2 mg aflibercept, 151 reports for 8 mg aflibercept, and 2 427 reports for faricimab were identified. Ocular AEs that were disproportionately over-reported for all of the 3 agents included intraocular injection complications, increased intraocular pressure, endophthalmitis, reduced visual acuity, eye inflammation, uveitis, visual impairment, and blurred vision.

Conclusions: In this study, faricimab generally showed lower point estimates for ROR of ocular AEs compared to 2 mg and 8 mg aflibercept; however, the wider confidence intervals for some outcomes reflect the limited number of reports and highlight the need for continued safety monitoring, particularly given the inherent reporting biases and lack of detailed patient or dosing information in the FAERS database.

Objective: To compare 5-year visual acuity trajectories in Leber hereditary optic neuropathy (LHON) by age at onset.

Design: A retrospective single-center cohort study.

Participants: Fifty-seven patients (114 eyes) with genetically confirmed, bilateral-onset LHON.

Methods: Serial best-corrected visual acuity (BCVA, logMAR) over 5 years was extracted from medical records. The age at onset was grouped as ≤19, 20-49, or ≥50 years. Sex and primary mutation (m.11778G>A vs m.14484T>C) were also assessed. Longitudinal trajectories were analyzed using linear mixed-effects models. Between-group differences were summarized using ΔlogMAR curves, area under the Δ curve (AUCΔ), and model-based probabilities of achieving logMAR ≤1.0.

Results: The median age at onset was 30.0 years (range: 8-69): 15 patients (26%) were ≤19 years old, 31 (54%) were 20-49 years old, and 11 (19%) were ≥50 years old. Relative to the 20-49-year reference group, the ≤19-year group had better visual outcomes over 5 years, with a negative AUCΔ and higher probabilities of achieving logMAR ≤1.0 (70.2% vs 13.6% at 60 months). The ≥50-year group showed poorer vision over time, with a positive AUCΔ and low probabilities of recovery. Differences by sex were small. Eyes with m.14484T>C had more favourable Δ trajectories than those with m.11778G>A, although the estimates were imprecise.

Conclusions: In this cohort, onset at ≤19 years was associated with earlier and greater visual recovery, whereas onset at ≥50 years was associated with persistently worse vision. Age at onset is an important modifier of 5-year visual prognosis in bilaterally affected LHON.

Objective: To evaluate anatomical and functional outcomes following a switch to intravitreal faricimab in patients with active, recalcitrant neovascular age-related macular degeneration (nAMD) previously treated with aflibercept in a real-life setting.

Design: A retrospective, observational, single-centre study.

Methods: Demographic data and prior intravitreal treatment (IVT) history were collected. Best-corrected visual acuity (BCVA) and disease activity were assessed using optical coherence tomography (OCT), including fluid compartments: intraretinal fluid, subretinal fluid (SRF), pigment epithelial detachment, and subretinal hyperreflective material.

Results: A total of 161 eyes from 145 patients (mean age: 80.1 ± 7.8 years) were included. Mean prior IVT duration was 2.9 ± 2.5 years. All eyes were active at the time of switching, with 82.0% showing persistent SRF. Disease inactivation occurred in 42.9% of eyes after the switch, more frequently in eyes with shorter prior treatment duration. BCVA remained stable throughout the follow-up. SRF resolved in 50.8% of eyes, with 52.2% achieving resolution after a single injection. Mean treatment intervals increased significantly in inactivated eyes (+4.9 ± 5 weeks). Disease relapse occurred in 54.6% of the initially inactivated eyes. No adverse events were reported.

Conclusions: Switching to faricimab may offer a valuable therapeutic option for recalcitrant nAMD, particularly in eyes with persistent SRF, providing improved anatomical outcomes while maintaining visual acuity in real-life practice. Prospective studies are warranted to better define response profiles and guide personalized treatment strategies.

Objective: To characterize clinical features, management, and outcomes of pediatric macular hole (MH) and to outline an etiology-guided aid.

Design: A retrospective, consecutive case series.

Participants: Pediatric MH patients diagnosed, surgically treated, and followed at a tertiary centre (March 2012 to January 2025).

Methods: Clinical data (age, sex, etiology, best-correct visual acuity [BCVA], intraocular pressure, axial length, MH size, and imaging) were reviewed. Etiology was classified as traumatic, secondary, or idiopathic. Vitreoretinal techniques and adjuncts were recorded.

Results: Eighty-eight eyes of 88 patients were included: traumatic 51/88 (58%), secondary 25/88 (28%), and idiopathic 12/88 (14%). At baseline, idiopathic MHs had better BCVA than traumatic (p = 0.05) and secondary (p = 0.003), while secondary MHs had longer axial length than traumatic MHs (p = 0.023). Imaging patterns differed by etiology (acute-injury changes in traumatic; proliferative/tractional features in secondary; relatively "pure" in idiopathic). Surgery reflected these patterns: internal limiting membrane flap/covering in 33% of traumatic MH; multiple adjuncts in secondary eyes (laser 56% with anti-vascular endothelial growth factor/steroid/buckle/oil); and primarily inert-gas tamponade in idiopathic MH (75%). Primary complete closure was 82%; final complete closure after reintervention was 84%. Mean final BCVA improved to 0.90 logMAR (≈20/160; p < 0.001), and the proportion with BCVA >20/200 rose from 47% to 68%. Visual gains were greatest in idiopathic and traumatic.

Conclusions: An etiology-informed, size/edge/traction-guided approach was associated with meaningful-though limited-visual improvement and high closure. These practice-informing data support early recognition, tailored surgery, and proactive complication management; a decision aid is provided. Prospective studies are needed to standardize thresholds and validate outcomes.

Objective: Recognition of factors associated with a greater need for treatment may be useful in managing retinopathy of prematurity (ROP). We aim to assess the relationship between nasal and temporal ROP on initial presentation and an infant's eventual need for treatment.

Methods: All patients screened for ROP between January 2018 and December 2020 were retrospectively reviewed. Data were collected on all patients (n = 286) with stage 1 or higher ROP. Eyes were classified as either nasal ROP or temporal-only ROP at initial presentation of ROP. Data from all ROP screening exams until treatment or completion of screening were reviewed. The primary outcome was treatment-required ROP. Additional data collected included birth weight, patient age, and laterality. Outcomes were compared using univariable and multivariable logistic regression analyses.

Results: Five hundred forty-two eyes were included for analysis. Eyes with nasal ROP on initial presentation were more likely to ultimately require treatment (63/197 [32%]) than eyes with temporal-only ROP on initial presentation (13/345 [4%]; odds ratio [OR]: 12.0, 95% CI: 6.40-22.54) using a univariable logistic regression analysis. A separate multivariable regression analysis demonstrated that eyes with nasal ROP remain more likely to require treatment (OR: 3.28, 95% CI: 1.54-6.99), even when also accounting for birth weight (OR: 0.40/100 g, 95% CI: 0.32-0.51), patient sex, and laterality.

Conclusions: Eyes with nasal ROP at initial presentation are more likely to eventually require treatment than those with temporal-only ROP at initial presentation, even when accounting for other risk factors. Nasal ROP at initial presentation should prompt particular attention when monitoring for progression of ROP.