Ophthalmology and Therapy最新文献

Introduction: Frequent anti-vascular endothelial growth factor (anti-VEGF) injections for the treatment of neovascular age-related macular degeneration (nAMD) burden patients and healthcare systems. Faricimab may reduce this burden, but robust data are lacking. This study aimed to systematically quantify the injection frequency reduction with faricimab compared to anti-VEGF agents and estimate Dutch budget impact.

Methods: A systematic review of studies on patients with nAMD switching to faricimab was conducted in PubMed. A hybrid approach using artificial intelligence (NotebookLM) and manual verification was employed for data extraction and risk of bias assessment. A random-effects meta-analysis determined the pooled mean difference in annual injections. A budget impact analysis estimated direct medical costs (drug and administration costs) over a 1-year time horizon using Dutch data.

Results: A meta-analysis of 19 real-world studies (2231 patients) was conducted. Patients switched to faricimab for persistent fluid or to extend treatment intervals, resulting in a significant mean reduction of 2.65 injections in the first year (from 9.70 to 7.05; 95% confidence interval - 3.36 to - 1.93). The base-case analysis projected annual savings of approximately €79 million, corresponding to 96,235 fewer injections nationwide. Scenario analyses showed that substantial savings (€16 to €75 million) can be achieved when using faricimab in second- and third-line settings, although replacing first-line bevacizumab would increase costs.

Conclusions: Switching patients to faricimab reduced the injection frequency by two to three injections in the first year. Although evidence certainty was limited by statistical heterogeneity, the reduction was consistent across studies. Although replacing first-line bevacizumab increases costs, substantial savings are achievable in later lines. Strategic positioning of faricimab in the second-line yields significantly higher savings compared to third-line use, and could significantly lower the clinical, patient, and economic burden of nAMD care in the Netherlands. These findings provide quantified, real-world evidence to inform Dutch clinical practice and healthcare policy.

Introduction: The Collaborative Normal-Tension Glaucoma Study (CNTGS) is frequently cited as evidence that a 30% reduction in intraocular pressure (IOP) slows progression in normal-tension glaucoma (NTG). This study re-examines the statistical methodology of CNTGS to assess how its conclusions are supported by the data.

Methods: This study reviews the CNTGS design with emphasis on survival analysis methodology, including the definition of time zero, censoring rules, and intention-to-treat (ITT) versus per-protocol comparisons. Particular attention is given to the post hoc redefinition of baseline and the handling of cataract-related visual decline, assessing their impact on the reported treatment effect.

Results: CNTGS shifted the analytical baseline for the treatment group to the point of IOP stabilization, thereby excluding early progression events and introducing immortal time bias. Additionally, cataract-related visual decline, more frequent in the treatment group, was censored rather than treated as a competing risk or time-dependent covariate. These methodological choices reduced the number of counted progression events in the treatment arm. Although the adjusted per-protocol analysis yielded a statistically significant treatment effect, this effect disappeared under the original ITT analysis, which included all randomized eyes from time zero and all progression events.

Conclusion: The potential treatment benefit reported in CNTGS depended largely on post hoc analytical modifications, whereas the original ITT analysis did not support a statistically significant effect of IOP reduction. These findings highlight the importance of transparent survival analysis methods and strict adherence to ITT principles in future NTG trials. Well-designed prospective studies that avoid immortal time bias and model treatment-related events appropriately are needed to clarify the true role of IOP reduction on NTG management.

Introduction: This study aimed to explore the safety and efficacy of sustained release bimatoprost implant with SpyGlass intraocular lens (SpyGlass Pharma, Inc., Aliso Viejo, CA, USA).

Methods: Twenty-four subjects diagnosed with cataracts and mild-to-moderate primary open-angle glaucoma were consented at a single site in Honduras. Those with pathologies that could confound outcomes were excluded. All subjects were required to have responded to topical prostaglandin analogues. Medication washout was performed prior to intervention. One eye of each subject was sequentially assigned to one of three arms (75 μg, 150 μg, or 300 μg of bimatoprost pads). The product was delivered in-the-bag via a commercially available intraocular lens (IOL) inserter and did not modify the steps of standard phacoemulsification cataract surgery other than attachment of bimatoprost implants to the IOL. We report interim results through 36 months.

Results: Twenty-one of 24 enrollees (87.5%) were retained through 36 months. Through 24 months, all subjects achieved the primary endpoint of intraocular pressure (IOP) reduction > 20% from baseline without any additional glaucoma medications. By month 36, all but a single subject (95.2%, n = 20) remained drop-free with continued IOP reductions > 20% across all remaining subjects. Each treatment arm realized mean IOP reductions from 32.3% to 49.3% over 3 years of follow-up visits. There were no significant intergroup differences. All eyes had a final best-corrected distance visual acuity of 20/30 or better. There were no serious implant-related adverse events. The most common events were dry eye (21.7%), transient vision decrease (13.0%), and subconjunctival hemorrhage (8.7%). All implants remained in the capsular bag.

Conclusions: The first human study of a novel system that mounts bimatoprost-infused pads to a single-piece IOL suggests favorable safety and efficacy and does not require additional surgical skills beyond routine cataract surgery. A larger sample with comparative data is necessary to further assess effects.

Trial registration: ClinicalTrials.gov identifiers, NCT07154797 and NCT07154810. Retrospectively registered on September 3, 2025.

Introduction: Diabetic retinopathy (DR) often causes vision loss and functional impairment. Standard low vision rehabilitation improves visual function but many patients cannot access it because of cost, travel, and limited specialist availability. We aimed to compare a home-based digital vision rehabilitation program to standard in-clinic rehabilitation in patients with DR.

Methods: We conducted a retrospective matched cohort study at a tertiary eye center in China. Adults with moderate to severe visual impairment from DR were included. A total of 380 patients were analyzed after 1:1 propensity score matching (190 per group). One group underwent a 12-week home-based digital physiotherapeutic vision training program delivered via a mobile app with daily exercises and weekly telehealth supervision, while the other group received standard in-person low vision rehabilitation over 12 weeks. The primary outcome was change in visual functional status measured by the Veterans Affairs Low-Vision Visual Functioning Questionnaire-48 (VA LV VFQ-48). Secondary outcomes included visual acuity, vision-related quality of life, depressive symptoms, mobility, metabolic control, and cost. Outcomes were assessed at baseline, 12, 24, and 48 weeks.

Results: Both the home-based digital training and standard in-clinic rehabilitation groups achieved substantial improvements in vision-specific functional status over 48 weeks. VFQ-48 scores increased by 22-26 points in each group, indicating clinically meaningful gains, and the digital program's improvement was comparable to standard care (demonstrating non-inferiority for the primary outcome). All secondary outcomes improved comparably in both groups, with no significant between-group differences. The digital intervention cost 7791 Chinese yuan (CNY) per patient over 48 weeks compared to 10,305 CNY with standard care, providing a net savings of 2514 CNY per patient. Both approaches were well tolerated, with no major safety concerns.

Conclusions: Home-based digital rehabilitation was non-inferior to standard in-clinic rehabilitation in improving functional vision, while substantially reducing costs and maintaining safety. These findings support implementing home-based or hybrid telerehabilitation models to broaden access to vision rehabilitation services.

Level of evidence: Level III retrospective cohort study.

No current treatments are curative for age-related macular degeneration (AMD), and preventing disease progression is challenging. Dietary factors play a role in the course of macular degeneration, and management of AMD commonly includes nutraceuticals (e.g., supplementation with a combination of antioxidant vitamins and minerals). This commentary summarizes the existing literature, emerging evidence, and upcoming research on the role of B vitamins in both preventing the development of AMD and slowing its progression.

Introduction: Patients frequently report visual sensations during ophthalmic surgery; however, data in uveitic eyes remain limited. Patients with Uveitis  represent a unique population group because of the chronic inflammatory course, systemic associations, and prolonged pharmacologic exposure, which may influence intraoperative perception and anxiety. This study aimed to characterize the nature and impact of intraoperative subjective visual experiences in patients with uveitis undergoing intraocular surgery or intravitreal injection and to evaluate the association of these experiences with uveitic activity, preoperative anxiety, and intraoperative physiological fluctuations.

Methods: This prospective cross-sectional observational study was conducted at a tertiary eye care hospital between June 2022 and July 2023. Seventy-six patients with uveitis undergoing anterior segment surgery, posterior segment surgery, or intravitreal injection were enrolled. Patients younger than 18 years, those requiring general anaesthesia, or with psychiatric/systemic disorders affecting perception were excluded. Demographic variables, uveitis type, systemic history, and visual acuity were recorded. Preoperative anxiety was assessed using the Amsterdam Preoperative Anxiety and Information Scale (APAIS). Intraoperative visual phenomena were evaluated postoperatively using a standardized questionnaire, while vital parameters (blood pressure, pulse rate, and SpO₂) were monitored throughout surgery.

Results: Among 76 patients (mean age 56 years; 48.7% male, 51.3% female), 60.5% underwent anterior segment surgery, 17.1% posterior segment surgery, and 22.3% intravitreal injections. All retained light perception intraoperatively. Common experiences included seeing colours (76.1% anterior; 61.5% posterior; 41.2% intravitreal), floaters (63%, 23%, 64.7%, respectively), and flashes (43.4%, 61.5%, 23.5%). Frightening perceptions occurred in 26.3% overall, significantly more in male patients (P = 0.008) and those with better preoperative visual acuity (P = 0.014). Notable intraoperative fluctuations were observed in systolic/diastolic blood pressure and pulse rate.

Conclusion: Patients with uveitis consistently experience intraoperative visual sensations irrespective of disease activity or surgical type. The occurrence of fear underscores the need for structured preoperative counselling, tailored anaesthetic management, and vigilant systemic monitoring to enhance patient comfort and surgical safety.

Trial registration no: CTRI/2022/07/043763.

Introduction: This study aimed to evaluate choroidal nevi (CN) volume as assessed by widefield optical coherence tomography (WF-OCT) and by ultrasound (US)-based mathematical approximations.

Methods: In a prospective, exploratory study, CN of consecutive patients were imaged with WF-OCT (VG 200D, Intalight Inc., San Jose, California, USA) and US (Quantel Absolu, Cournon, D'Auvergne Cedex, France). Volume was assessed by CN annotation on 64 B-scans on WF-OCT and two approximations based on US measurements (thickness, largest and perpendicular basal diameter (LBD; PBD)): (a) π/6 × thickness × LBD × PBD and (b) 2π/3 × [(LBD + PBD)/4]² × thickness.

Results: Eighteen nevi of 18 patients were included in the study. Mean volume evaluated on WF-OCT was 15.1 ± 24.1 mm³. US approximations resulted in (a) 23.0 ± 35.0 mm³ and (b) 23.5 ± 35.5 mm³. Intraclass correlation coefficients showed very good agreement between WF-OCT and US measurements (a) of 0.947 (CI 0.860-0.980) and (b) of 0.945 (CI 0.853-0.979). Stepwise backward elimination multivariable linear regression showed an association between difference of volume measurements and lesion thickness and LBD for approximations (a) and (b).

Conclusion: WF-OCT and US-based approximations show good interdevice reliability for CN volume in this exploratory study. Thickness and LBD have significant impact on discrepancy of volume measurements with a tendency that small CN are underestimated and large CN are overestimated with US. This potentially limits interchangeable use of US and WF-OCT.

Introduction: Despite refractive correction and patching, some patients have residual amblyopia. In the current study, we compared the effectiveness of daily 6-hours (6-h) intensive patching and a newly developed individualized and adaptive vision training (iAVT) protocol for residual amblyopia in children.

Methods: In a randomized clinical trial, 60 children aged 4 to under 11 years with residual amblyopia and visual acuity ranging from 0.2 to 0.8 logarithm of the minimum angle of resolution (logMAR) were assigned to receive either 50 sessions of iAVT training or 6 h of daily patching for 10 weeks.

Results: Visual acuity in the amblyopic eye improved more in the iAVT group than in the extended patching group (0.13 versus 0.07 logMAR; 95% confidence interval (CI) 0.010-0.100; p = 0.017) over 10 weeks. At 2 weeks, the iAVT group also showed a faster improvement compared with the patching group (0.09 versus 0.06 logMAR; 95% CI -0.004 to 0.067; p = 0.076). Meanwhile, no significant between-group difference was found in the area under the log contrast sensitivity function (AULCSF) change. However, the AULCSF of the iAVT group showed a marginally significant within-group improvement from base to week 10 (0.78 versus 0.89; 95% CI -0.225 to 0.001; p = 0.056), while no significant change was observed in the patching group. The iAVT group also reported higher quality-of-life scores after treatment, as monitored by the Pediatric Eye Questionnaire.

Conclusions: The iAVT provided a faster and more effective treatment for residual amblyopia compared with 6-h patching within the 10-week treatment period. These results suggest that iAVT may be an important new approach to treating residual amblyopia.

Trail registration: Chinese Clinical Trial Registry, ChiCTR2300075594. Registered on 8 September 2023-retrospectively registered.

Introduction: Intact corneal sensation plays a vital role in maintaining ocular surface health. Various ocular surface pathologies can present with differing levels of decreased corneal sensation, while in some cases patients may instead experience heightened sensation. This study compared corneal sensitivity with the new quantitative non-contact esthesiometer (NCE, Brill, USA) and the conventional qualitative cotton wisp (CW) test in patients with ocular surface diseases (OSD).

Methods: A retrospective, cross-sectional study was conducted, including patients with OSDs, who had both CW and NCE test results available. Descriptive analysis of one eye per patient was performed to compare the distribution of patients according to NCE and CW responses.

Results: Of 139 eyes (n = 139 patients), 129 (92.8%) were CW+ and 10 eyes were CW- (7.2%). Among these, 111 eyes responded to levels 1-3 when assessed with NCE, with 38 (34.2%) responding to level 1, 45 (40.5%) to level 2, and 28 (25.2%) to level 3. However, of CW+ eyes, 10 (7.8%) responded to level 4 and 6 (4.7%) responded to level 5 of NCE, while 2 (1.6%) had no response to any NCE stimulation (i.e., level 6), indicating varying degrees of hyposensitivity not detected by CW. Of the 10 eyes (7.2%) that did not respond to CW (CW-), 3 responded to level 4, and one to level 5 of NCE, while 4 eyes (40.0%) failed to respond to NCE (level 6). Notably, two CW- patients responded to level 1 NCE, suggesting potential hypersensitivity. Results showed high sensitivity (98.2%, 95% CI 93.8-99.8%) but low specificity (30.8%, 95% CI 14.3-51.8%) of the CW test in patients with OSD when level 4 of NCE (i.e., levels 4, 5, and 6) was used as the cutoff for defining corneal hyposensitivity.

Conclusion: Our results demonstrate that the low specificity of the qualitative CW test, combined with a broad confidence interval, indicates a high likelihood of false-positive results. This suggests that a positive CW test may not reliably rule out hyposensitivity, underscoring the need for further evaluation in the setting of a positive CW test result.