Ophthalmology and Therapy最新文献

Introduction: This study evaluates the efficacy and safety of faricimab in a real-world cohort of treatment-naïve patients with neovascular age-related macular degeneration (nAMD). Data were retrospectively collected from 130 eyes of 118 patients across 11 centers of the Swiss Retina Research Network, all treated with faricimab using a treat-and-extend regimen and followed for 12 months between May 2022 and October 2024.

Methods: Demographic data, visual and anatomical outcomes, treatment intervals, and adverse events were extracted from the electronic medical records over a 12-month follow-up period. Main outcomes included change in best corrected visual acuity (BCVA), central retinal thickness (CRT), presence of intra- and subretinal fluid, retinal pigment epithelial detachment (PED), injection intervals, and safety. Data are presented as mean ± standard deviation.

Results: Twelve months after the initiation of faricimab therapy, mean BCVA improved from 64.6 ± 14.1 to 69.2 ± 20.3 ETDRS (Early Treatment of Diabetic Retinopathy Study) letters (p < 0.001), while mean CRT decreased from 386.3 ± 172.3 to 246.6 ± 90.4 μm (p < 0.001). An early anatomical response to faricimab was observed in 34.6% of eyes achieving complete retinal fluid resolution after the first injection and in 55.6% after 12 months. The mean treatment interval was extended to 10.5 ± 4.3 weeks, with 26.2% of eyes achieving intervals of 8-11 weeks and 39.2% achieving intervals of ≥ 12 weeks after 12 months. Intraocular inflammation occurred in 0.77% of eyes (n = 1, anterior uveitis); serious adverse events were not reported.

Conclusion: Faricimab demonstrates favorable anatomical and functional outcomes with extended treatment intervals in a majority of patients with treatment-naïve nAMD, offering the potential of reduced treatment burden and the absence of retinal fluid in more than half of the subjects during the first year, while maintaining safety in a real-world setting.

Introduction: Neuropathic corneal pain (NCP) is a challenging condition with limited consensus on its diagnosis and management. This study aimed to gather global insights from corneal specialists on the causes, investigative approaches, and management strategies for NCP.

Methods: A 32-question survey covering demographic, causes, investigations, treatments, and multidisciplinary engagement was sent to 152 invited international corneal specialists; 51 (34%) responded. We explored descriptive statistics and examined how responder characteristics influenced their answers.

Results: The most reported causes of NCP were chronic ocular surface disease (n = 41; 41%) and post-surgical factors (n = 34; 34%). The most common investigations, routinely performed by respondents, were the anesthetic challenge test, Schirmer's test, and corneal esthesiometry. In vivo confocal microscopy (IVCM) was routinely used by 37% (n = 19), with 69% (n = 29) of specialists stating that an abnormal result influenced their management. Ocular surface and pain questionnaires were used by 69% (n = 35), with the Ocular Surface Disease Index being the most popular (n = 25; 31%). Common treatments included artificial tears (n = 48; 94%), serum/plasma-derived tears (n = 41; 80%), topical corticosteroids (n = 34; 67%), and topical cyclosporin (n = 30; 59%). Only 38% (n = 19) felt comfortable independently prescribing systemic pharmacotherapy. A multidisciplinary approach was adopted by 47% (n = 24), with the two most common specialties involved being pain management (n = 30; 37%) and neurology (n = 26, 32%).

Conclusions: This survey provides valuable global insights into the causes, investigations, and management of NCP from the perspective of corneal specialists. These findings support further research and the development of guidelines to address this challenging condition.

Vision impairment resulting from defects in the visual pathway was once considered irreversible. The main barrier is the limited plasticity of the visual system after the critical period. However, as our understanding of noninvasive brain stimulation (NIBS) deepens, its ability to enhance neural plasticity and regulate the neural system indicates a transformation in treatment and rehabilitation strategies. To verify the potential of NIBS in visual restoration, this review elaborates on the mechanisms underlying the immediate effects and aftereffects of NIBS with proofs from molecular, cellular, and systematic levels. The concept of neural oscillation is especially emphasized as it contributes greatly to cognition and can be interfered with by NIBS. Meanwhile, it discusses recent clinical findings on the use of NIBS, with or without visual perceptual learning, focusing on two key questions which have not been specified in previous reviews: (1) the duration of behavioral improvements, and (2) the optimal treatment period required for different visual functions and NIBS modalities. On the basis of the inconsistency in existing studies, this review is also devoted to optimizing the practical application of combining NIBS with VPL and concludes that the location, timing, and form of NIBS are crucial to achieving satisfying complementary effects.

Introduction: The purpose of this analysis was to assess the safety outcomes of a subgroup of patients who received a travoprost intracameral implant in an office-based surgery setting from one of the phase 3 registration trials, GC-012, for the implant.

Methods: Adult patients with open-angle glaucoma or ocular hypertension on 0 to 3 pre-study intraocular pressure (IOP)-lowering medications underwent a washout period (if applicable). Patients who qualified based on having an unmedicated mean diurnal IOP of 21 mmHg or greater and an IOP of 36 mmHg or less at each of the diurnal timepoints received a travoprost intracameral implant and were followed for safety outcomes at eight visits over a 12-month period. Safety evaluations included adverse events, slit-lamp examination, gonioscopy, pachymetry, dilated fundus examination, specular microscopy, perimetry, and best-corrected visual acuity.

Results: A total of 37 patients received a travoprost intracameral implant in an office-based surgery setting. Administration of the implant was successful in 100% of patients. There were no serious ocular adverse events or ocular infections in patients administered the implant.

Conclusions: This subgroup analysis demonstrated that administration of the travoprost intracameral implant in an office-based surgery setting was safe and well tolerated.

Trial registration: ClinicalTrials.gov identifier, NCT03868124.

Introduction: Neurotrophic keratitis (NK) is a rare, vision-threatening corneal disease characterized by impaired epithelial healing and frequent recurrence of defects. Amniotic membrane transplantation (AMT) is an established therapeutic option, but outcomes remain variable and predictors of failure are poorly defined. We aimed to identify clinical and systemic factors associated with recurrence following AMT using both classical statistics and machine learning approaches.

Methods: We conducted a retrospective cohort study of 66 patients with NK who underwent AMT at a tertiary referral center between 2019 and 2025. The primary endpoint was post-AMT epithelial defect recurrence. The prespecified primary analysis was a multivariable logistic regression, complemented by exploratory machine learning approaches. Clinical, demographic, and ophthalmic variables were abstracted from medical records. All patients had complete outcome data; covariate-level missingness was minimal and handled with complete-case analyses. Associations with recurrence were examined using bivariate tests and multivariable regression; data structure was explored with principal component analysis (PCA) and hierarchical clustering; and predictive performance was additionally evaluated using random forest classifiers.

Results: Epithelial defect recurrence occurred in 46 patients (70%). Multivariable analysis identified systemic immunosuppressive therapy (odds ratio [OR] 19.9; p = 0.023) and number of AMTs (OR 2.73 per graft; p = 0.040) as independent predictors, with prior ocular surgery showing a borderline association (p = 0.060). PCA and clustering revealed three phenotypic subgroups, including a high-risk cluster (72% recurrence) characterized by immunosuppression, multiple AMTs, prior surgery, and inflammatory complications. Random forest classification confirmed the predictive role of these variables, achieving an AUC of 0.82 with balanced sensitivity (74%) and specificity (81%).

Conclusion: Systemic immunosuppression, repeated AMTs, and prior ocular surgery are key predictors of AMT failure in NK. Combining regression models, clustering, and machine learning provides a robust framework for risk stratification. These findings support the development of personalized monitoring and treatment strategies to improve surgical outcomes in NK.

Introduction: Neurotrophic keratopathy (NK) is a rare degenerative disease that can lead to epithelial breakdown, corneal ulceration, and potentially perforation and vision loss. Cenegermin is a recombinant human nerve growth factor approved for stage 2/3 NK, though data on its efficacy outside of United States/European populations are limited.

Methods: This prospective, phase IV, open-label, multicenter study investigated the efficacy, safety, and pharmacokinetics (PK) of cenegermin eye drops in Chinese patients with stage 2/3 NK in a routine clinical setting (CTR20220066). Patients received cenegermin eye drops (20 mcg/mL; 6 times/day at 2-hour intervals) for 8 weeks with follow-up to week 56. The primary endpoint was corneal healing at week 8 per investigator assessment. Additional endpoints included lesion worsening, corneal healing through week 56, safety, and PK.

Results: Of the 28 patients receiving cenegermin, 22/26 (84.6%, 95% confidence interval 65.1-95.6%; 2 missing) achieved corneal healing at week 8; 3/22 (13.6%) reported recurrence during 48-week follow-up but 20/22 (90.9%) were healed at week 56; and 2/28 (7.1%) experienced lesion worsening during 8-week treatment. In addition, 25/28 (89.3%) experienced ≥ 1 treatment-emergent adverse event (TEAE); for the majority (23/28, 82.2%) of these patients, TEAEs were mild/moderate. None of the serious TEAEs reported by 10 (35.7%) patients were assessed as related to cenegermin or led to treatment discontinuation. Eye pain was the most common cenegermin-related TEAE (5/28, 17.9%), primarily limited to the treatment period.

Conclusions: These findings demonstrate that cenegermin eye drops are an effective, generally well-tolerated treatment in Chinese patients with stage 2/3 NK, supporting their use in this patient population.

Trial registration: CTR20220066.

Introduction: This study aimed to apply a deep learning-based artificial intelligence (AI) system for quantitative analysis of retinal vascular morphology in patients with circumscribed choroidal hemangioma (CCH), and to explore differences based on lesion location.

Methods: This retrospective case-control study included 45 treatment-naive CCH eyes and their contralateral healthy eyes as controls, recruited from 45 patients (mean age: 44.91 ± 11.98 years; 10 female patients). Retinal photographs were analyzed using AI software to extract vascular parameters, including vessel density, caliber, tortuosity, and fractal dimension. Inter-group comparisons and conditional logistic regression were conducted. Subgroup analysis was performed based on the lesion's position relative to the optic disc.

Results: Compared with controls, CCH eyes showed significantly reduced vascular density (p < 0.005) within 3 mm and 5 mm of the fovea. Venular caliber was significantly increased across multiple concentric zones (1.0-2.5 papillary diameter, PD), while arteriole-to-venule ratio (AVR) was decreased (p < 0.001). Tortuosity and fractal dimension of both arterioles and venules were significantly reduced (all p < 0.05). Logistic regression confirmed vessel caliber (p = 0.001), AVR (p = 0.001), tortuosity (p = 0.006), and fractal dimension (p = 0.004) as significant parameters associated with CCH. Lesions within 1.0 PD of the optic disc were linked to lower arteriolar caliber and AVR (p < 0.05).

Conclusion: Retinal vascular morphological alterations are evident in CCH and vary with lesion location. Key parameters, such as vascular density, venular caliber, AVR, and fractal dimension, may serve as potential imaging biomarkers for evaluating and monitoring CCH-related retinal changes.

Introduction: To compare the U.S. Food and Drug Administration (FDA) premarket approval (PMA) trials of topography-guided laser in situ keratomileusis (TG-LASIK) and ray tracing-guided LASIK (RT-LASIK) for the treatment of myopia and myopic astigmatism.

Methods: This comparative study was conducted between TG-LASIK (P020050/S012; Alcon Laboratories, Inc., Fort Worth, TX, USA) with Allegretto Wave Eye-Q laser and topography-guided custom ablation treatment planning software, and "WaveLight Plus" RT-LASIK (P020050/S043; Alcon Laboratories, Inc.) using the WaveLight EX500 excimer laser and InnovEyes Sightmap. Clinical outcomes were compared, including visual and refractive measures, astigmatic correction, mesopic contrast sensitivity, higher-order aberrations, and patient-reported outcomes.

Results: This analysis included 249 eyes (212 patients) that underwent TG-LASIK and 336 eyes (168 patients) that underwent RT-LASIK. At 12 months, uncorrected distance visual acuity of 20/16 or better (64.8% TG-LASIK vs. 70.2% RT-LASIK) and 20/20 or better (92.6% TG-LASIK vs. 94.4% RT-LASIK) did not differ statistically between platforms. However, more TG-LASIK eyes had 20/10 or better (15.7% vs. 2.5%, P < 0.001) and 20/12.5 or better (34.4% vs. 26.4%, P = 0.044) than RT-LASIK eyes. Both platforms demonstrated comparable refractive predictability and stability (P > 0.05). For preoperative cylinder between - 1.00 to - 4.00 D, RT-LASIK showed greater astigmatic overcorrection (P < 0.05). At 3 months, RT-LASIK showed higher mesopic contrast sensitivity at 3, 6, and 12 cycles per degree under glare, with more eyes achieving clinically significant gains compared to TG-LASIK (P < 0.001). Both platforms induced changes in total higher-order aberrations, although not clinically significant. RT-LASIK also reduced spherical aberration from baseline. Both procedures showed a reduction in symptom severity for glare, halos, starburst, double vision, and dry eye.

Conclusions: While TG-LASIK showed superior visual acuity outcomes, RT-LASIK was associated with higher contrast sensitivity; however, both platforms demonstrate excellent visual and refractive outcomes. The majority of published studies are consistent with FDA PMA trends, showing potential reductions in spherical aberration and higher rates of 20/20 or better visual acuity with RT-LASIK.

Introduction: Thyroid eye disease (TED) is a rare, autoimmune, orbital inflammatory disorder that is disfiguring, debilitating, and potentially sight-threatening. There is an unmet need for a fast-acting, durable, systemic disease-modifying therapy in active TED, for which current options are associated with relapses and side effects, and for chronic inactive TED, which is largely managed with surgery. Satralizumab is a recombinant humanized anti-interleukin-6 receptor (IL-6R) monoclonal antibody that prevents IL-6 from binding to its receptor, thereby reducing proinflammatory and profibrotic signaling. The SatraGO-1 and SatraGO-2 trials evaluated the efficacy, safety, pharmacokinetics, and pharmacodynamics of satralizumab in participants with active, moderate-to-severe, and chronic inactive TED.

Methods: SatraGO-1 and SatraGO-2 were two identically designed, 72-week, double-masked, placebo-controlled, multicenter, two-stage randomization, phase 3 trials in adults with active, moderate‑to‑severe TED or chronic inactive TED. Participants were randomized 1:1 to receive satralizumab or matching placebo. Based on the proptosis response assessed at week 24, nonresponders received satralizumab every 4 weeks (Q4W), while responders were rerandomized in a 1:1 ratio to receive satralizumab or placebo Q4W through week 44. The primary end point was the proportion of participants with active, moderate-to-severe TED who achieved ≥ 2-mm reduction in proptosis in the study eye from baseline at week 24.

Results: SatraGO-1 and SatraGO-2 enrolled 131 and 127 participants, respectively.

Conclusions: The SatraGO-1 and SatraGO-2 trials investigated IL-6R inhibition via satralizumab in TED. Satralizumab offers a potential disease-modifying treatment option for TED while minimizing safety risks associated with current treatments.

Trial registration: SatraGO-1 (NCT05987423) and SatraGO-2 (NCT06106828).

Introduction: Short-term side effects often hinder the adoption of low-dose atropine in myopia management. Evidence from long-term observations and guidance on optimal dosing frequency is needed to inform clinical practice. This study aims to evaluate the effects of 0.05% atropine on near-work-related effects, accommodation, and binocular vision over 1 year of treatment.

Methods: Chinese children with myopia (aged from 6 to 14 years, cycloplegic spherical equivalent ≤ -1.00 D in both eyes) were enrolled between March 2021 and August 2023 at Changsha Aier Eye Hospital. Participants were randomly assigned to three regimen groups of 0.05% atropine: once daily (Qd), twice per week (Tw), and once per week (Qw) groups. Reported visual quality related side effects, the change of near work parameters, including visual acuity, reading distance, accommodation and binocular vision under the use of 0.05% atropine during 12 months were the main study outcomes.

Results: A total of 205 children were included in the study, 76 in Qd group, 70 in Tw group, and 59 in Qw group. Self-reported side-effects remained low in all groups, but showed frequency dependence. No cases of strabismus were reported or diagnosed. The most complaint side-effect was photophobia and blur at near (7.9% and 7.9%) at week 2 in Qd group, and both dropped to 3.9% at month 12. Pupil size under both photopic and mosopic, and viewing distance when reading consistently enlarged compared with baseline. All groups showed short-term changes in accommodation, and binocular vision, but gradually returned to baseline level by month 12. Mean (SE) of accommodation convergence to accommodation ratio (AC/A) in Qd group was 5.13(0.15), 5.82(0.16), 5.33(0.17), 5.22(0.17) Δ/D at baseline, week 2, month 6, and month 12, respectively; 5.09(0.16), 5.48(0.19), 5.42(0.19), 5.22(0.16) Δ/D in Tw group; and 4.90(0.19), 5.32(0.20), 5.17(0.19), 5.17(0.18) Δ/D in Qw group.

Conclusions: Long-term use of 0.05% atropine appears to be safe in children with myopia. Although short-term visual function changes and side effects were associated with higher dosing frequency, these effects were largely transient and resolved over time.