Ophthalmic Research最新文献

Purpose: To evaluate the efficacy of faricimab in neovascular age-related macular degeneration (nAMD).

Methods: This systematic review and meta-analysis was performed according to the PRISMA guidelines to identify studies assessing faricimab in nAMD. Primary outcomes included visual acuity, central macular thickness (CMT), and dry macula rate. Secondary outcomes included macular status, central choroidal thickness (CCT), and complications. A random-effects model was used to calculate pooled mean with 95% confidence intervals.

Results: Out of the 365 studies identified, 21 studies were included, comprising a total sample size of 1864 eyes of 1791 patients. Post-operatively, there was a statistically significant improvement in corrected distance visual acuity (CDVA) (SMD: -0.122, 95% P = 0.039) and CMT (SMD: -3.672, P = 0.010). Similarly, there was a significant improvement in the rate of dry macula at the final follow-up visit (event rate: 0.529; P < 0.05). For the secondary outcomes, there was a statistically significant improvement in CCT (SMD: -0.199, P = 0.026) and in the rate of macular exudates (0.452, P < 0.05), specifically intraretinal fluid (0.140, P < 0.05) and subretinal fluid (0.271, P < 0.05). Complications secondary to faricimab injections included hemorrhagic pigment epithelial detachment (PED) with a rate of 0.120 (P < 0.05) and retinal pigment epithelium (RPE) tear with a rate of 0.025 (P < 0.05).

Conclusions: The use of faricimab injection in patients with nAMD is safe and effective, resulting in significant improvements in a myriad of visual measures and OCT parameters.

Introduction: Corneal fluorescein (FL) staining is the most widely used efficacy endpoint in dry eye disease (DED) registrational trials, yet dye diffusion and variable readout timing can blur punctate staining, reducing the precision and consistency of grading. We assessed the performance of FL staining as an efficacy endpoint by analyzing endpoint success across FDA-reviewed DED trials and evaluated whether a standardized, diffusion-resistant dye could provide an alternative quantitative measure of corneal staining.

Methods: We conducted a synthesis of FDA-reviewed DED registrational clinical trials through April 2025 to determine the proportion of trials that met the corneal FL staining efficacy endpoint. Clinical relevance was assessed using a minimal clinically important difference (MCID) of ≥3 units on the 0-15 National Eye Institute (NEI) scale. In a clinical cohort of 50 DED patients (97 eyes), total corneal staining was compared after sequential instillation of 5 µL of 2% FL (readout ~2.5 min) and 1% lissamine green (LG) (readout ≤30 sec).

Results: Among 20 FDA-reviewed registrational trials that prespecified corneal FL staining as an efficacy endpoint, 10 (50%) failed to meet this endpoint. Of the seven trials in which FL staining served as a primary or co-primary endpoint, only one achieved MCID for corneal staining. Across all trials meeting the endpoint, treatment-vehicle differences were small (mean additional reduction 0.4-1.2 units; Cohen's d < 0.5), indicating that FL staining yielded uniformly small effect sizes. In the clinical cohort, 1% LG produced corneal staining that was strongly associated with 2% FL for mild (ρ = 0.99), moderate (ρ = 0.93), and severe (ρ = 0.69) disease (p < 0.001). Bland-Altman analysis showed that while the mean bias was negligible, the width of the 95% limits of agreement (-1.26 to 0.85) suggests the two corneal staining dyes are not fully interchangeable at the individual-measurement level.

Conclusions: Corneal FL staining demonstrates limited responsiveness as an efficacy endpoint in DED registrational trials. Because 1% LG provides corneal staining strongly associated with 2% FL while preserving discrete punctate detail and allowing standardized, early readouts, it may represent a suitable alternative vital dye for future DED efficacy and safety assessments.

Background: Age-related macular degeneration (AMD) is a major cause of irreversible vision loss in middle-aged and older populations worldwide. Understanding its long-term epidemiological trends is essential for anticipating future healthcare needs and guiding preventive strategies. This study characterizes the global, regional, and national burden of AMD in adults aged ≥45 years, with a focus on sex disparities, aging effects, and projected trends Methods: Using data from the Global Burden of Disease Study 2021, we analyzed the prevalence and disability-adjusted life years (DALYs) of AMD across age, sex, region, country, and Socio-Demographic Index (SDI) groups. We applied an Age-Period-Cohort (APC) model to disentangle the effects of aging, temporal changes, and birth cohort on AMD risk. Frontier analysis was conducted to identify best-practice benchmarks in disease burden reduction. The association between SDI and AMD burden was assessed to evaluate health inequities. An Autoregressive Integrated Moving Average (ARIMA) model was used to project age-standardized DALY rates (ASDR) and prevalence rates (ASPR) from 2022 to 2036.

Results: Between 1990 and 2021, the absolute number of AMD cases and DALYs nearly doubled. In 2021, both prevalence and DALY rates increased exponentially with age, with females exhibiting consistently higher rates across all age groups. The APC model indicated a declining trend in AMD risk over successive birth cohorts, suggesting potential improvements in early-life or cumulative risk factors. Notably, the highest age-standardized rates were observed in low-SDI regions, highlighting significant global inequities in disease burden. ARIMA projections suggest a modest but concerning increase in the global ASDR, rising to 6.80 (95% CI: 5.82-7.78) by 2036, with female ASDR reaching 7.46 (95% CI: 6.29-8.63).

Conclusions: The burden of AMD remains substantial and is projected to grow, particularly among aging populations and in low-resource settings. The persistent sex disparity, especially the elevated burden in elderly women, calls for targeted screening and intervention programs. These findings emphasize the need for equitable, age- and sex-sensitive public health strategies to mitigate the rising impact of AMD in the coming decades.

Purpose: This study evaluated changes of Schlemm's canal (SC) and trabecular meshwork (TM) dimensions from digital ocular massage in high myopia.

Methods: Healthy participants with either high myopes (≤ -6.00 D) or with refractive errors ≥ -3.00 D were recruited. Right eyes underwent digital ocular massage. Intraocular pressure (IOP) was monitored using rebound tonometry. Anterior chamber angle was imaged using swept-source optical coherence tomography (SS-OCT). IOP, SC and TM were compared before and immediately after digital ocular massage.

Results: Sixteen eyes from 16 high myopes (-6.00 D to -8.125 D) and 18 eyes from 18 control participants (+0.50 D to -2.875 D) were included. There was no difference in age and gender distribution between the two groups. The two groups shared similar IOP, SC area, SC length, TM length, and TM thickness at baseline. Both groups had significant IOP drop from a baseline of around 15mmHg to 9mmHg after ocular massage. High myopia demonstrated a mild enlargement of the SC area (from 10655.60 +/- 4362.02 µm² to 12632.40 +/- 4393.19 µm², p = 0.098) not reaching statistical significance. The TM thickness was reduced from 160.21 +/- 26.29 µm to 151.77 +/- 26.91 µm, p = 0.018). Control eyes showed significant enlargement of SC area (from 8540.71 +/- 3905.98 µm² to 11686.53 +/- 4586.37 µm², p = 0.001), and SC length (from 240.47 +/- 69.96 µm to 280.40 +/- 59.37 µm, p = 0.041).

Conclusions: Control eyes showed significant enlargement of SC in responding to IOP drop while high myopia did not.

Purpose: Previous studies have demonstrated the efficacy of Faricimab where the intervention in treatment-resistant neovascular age-related macular degeneration (nAMD) had been switched from Aflibercept to Faricimab. This exploratory study aimed to assess the clinical anatomical and functional outcomes of a single intravitreal Faricimab (IVF) injection in those with treatment-resistant nAMD who switched from Aflibercept, in a single tertiary ophthalmology centre.

Methods: This retrospective, observational real-world study assessed 20 patients (21 eyes) with treatment-resistant nAMD who were switched from intravitreal Aflibercept (IVA) to Faricimab due to persistent subretinal fluid (SRF) despite frequent Aflibercept injections. Patients were switched to a regimen of Faricimab consisting of three loading doses administered at 4-weekly injections. Anatomical and functional measures were assessed at two time points: immediately before the initial Faricimab injection and approximately 4 weeks later, before the second Faricimab injection. The outcome measures were: visual acuity, central macular thickness (CMT), macular volume, and the presence of SRF were evaluated pre- and post-switch.

Results: Twenty-one eyes from 20 patients were analyzed. Statistically significant reductions in CMT (from 570.2 to 482.7 μm; p < 0.01) and macular volume (from 8.57 to 7.87 mm³; p = 0.02) were observed post-switch, while the change in visual acuity did not reach statistical significance (p = 0.051). The number of eyes with SRF decreased from 21 pre-switch to 9 post-switch.

Conclusion: The findings from this exploratory study suggests that switching from Aflibercept to Faricimab demonstrated significant physiological improvements among patients with treatment-resistant nAMD. Faricimab may serve as an effective and safe option in this patient population. The exploratory study also identifies changes in CMT and macular volume as outcome measure candidates for future large-scale investigations.

Purpose: This study aimed to characterize the differential indications and compare anatomical and visual outcomes between pars plana vitrectomy (PPV) and posterior scleral contraction (PSC) in eyes with myopic traction maculopathy (MTM).

Methods: One hundred seventy-five eyes with MTM from 157 patients who were treated with PSC or PPV and had at least 6 months of follow-up were retrospectively analysed. Best-corrected visual acuity (BCVA) was used to assess visual outcomes. Anatomical outcomes were assessed using optical coherence tomography.

Results: The PPV and PSC groups included 87 and 88 eyes, respectively. Eyes in the PPV group presented with higher presence of epiretinal membrane (93.1% vs. 69.3%, P<0.001), larger macular hole (MH) diameter (128.0 μm vs. 0 μm, P=0.01), and more severe pattern of MH (e.g., full thickness MH 18.4% vs. 10.2%, P<0.001), whereas achieved better anatomical outcomes (MH recovery rate: 89.9% vs. 50.0%, P <0.001; incidence of complete or essential recovery: 82.8% vs. 61.4%, P <0.001; the median time to recovery: 90 days vs. 307 days. P<0.001). Additionally, better recovery of retinal profile in PPV group tended to be more significant in eyes with axial length (AL) ≤30 mm. Conversely, eyes in the PSC group presented with more advanced MTM Staging System (e.g., stage 4 13.6% vs. 4.6%, P=0.003) and larger highest cavity of maculoschisis or macular detachment (389.3 ± 229.8 μm vs. 322.2 ± 216.4 μm, P=0.048), resulting in significant reduction in AL postoperatively (29.9 ± 1.6 mm before surgery vs. 28.2 ± 1.6 mm at last follow-up, P <0.001). In multivariate linear regression analysis, type of operation did not have a significant impact on BCVA at last follow-up or on change in BCVA after surgery.

Conclusions: PPV was typically performed for eyes with severer vitreoretinal interface abnormalities and achieved better outcomes, particularly in eyes with AL ≤ 30mm. PSC was performed for eyes with advanced MTM Staging System, providing better axial stabilization despite slower anatomical improvement. Both approaches improved visual acuity to a similar extent, irrespective of the surgical technique employed.

Introduction: This study aimed to assess visual and refractive outcomes and cost utility of toric intraocular lens (IOLs) implantation in cataract patients over 80 with corneal astigmatism.

Methods: Patients >= 80 years with corneal astigmatism >= 1.50 diopters (D) who underwent cataract surgery with toric or monofocal IOLs were enrolled. Uncorrected distance visual acuity (UDVA) and residual refractive astigmatism at the 3-month postoperative follow-up were compared between the toric and non-toric groups. Cost data were gathered, long-term quality-adjusted life years (QALYs) were calculated, and the incremental cost-effectiveness ratio (ICER) was determined.

Results: The study included 50 eyes from 50 patients, with 25 eyes receiving toric IOLs and the remaining 25 receiving non-toric IOLs. Three months after surgery, both the mean UDVA (P < 0.0001) and the mean residual refractive astigmatism (P < 0.0001) in the toric group significantly outperformed those in the non-toric group. An average of 4.04 ± 0.25 QALYs were obtained in the toric group through cataract surgery, while 3.78 ± 0.26 QALYs were obtained in the non-toric group. The median ICER stood at 11,222 CNY (1,753 USD) per QALY [95% CI: 5,840 ~ 25,295 CNY (913 ~ 3,952 USD) per QALY], which is lower than the threshold of cost-effectiveness in China (80,976 CNY (12,653 USD) per QALY).

Conclusion: In cataract patients aged over 80 with corneal astigmatism and no complicating vision-threatening conditions, toric IOL implantation not only improved UDVA and reduced residual astigmatism but also emerged as a cost-effective intervention compared with non-toric IOL implantation.

Purpose: To evaluate the rotational stability of three toric intraocular lens (TIOL) platforms in patients undergoing repositioning surgery.

Methods: This comparative retrospective study enrolled eyes that underwent cataract surgery and implanted with a AcrySof, AT TORBI/LISA, or TECNIS TIOL. Patients who experienced TIOL misalignment ≥10° postoperatively and underwent repositioning surgery were included. The incidence of repositioning surgery after cataract surgery and the misalignment degree before and after repositioning surgery of the three TIOL platforms were mainly compared.

Results: Of the 2598 eyes implanted TIOLs, 56 eyes (2.156%) undergoing repositioning. The repositioning rates for the AcrySof, AT TORBI/LISA, and TECNIS platforms were 0.848% (10/1179), 2.935% (28/954), and 3.871% (18/465), respectively, showing significant differences (P<0.001). Misalignment degrees before repositioning surgery for the AcrySof, AT TORBI/LISA, and TECNIS TIOLs were 27.90±15.74°, 60.79±18.79°, and 31.61±20.84°, respectively (P<0.001). AT TORBI/LISA platform had a significantly greater misalignment degree compared to AcrySof (Difference:32.89°, P<0.001) and TECNIS platforms (Difference:29.18°, P<0.001). There was no significant difference between AcrySof and TECNIS (Difference:3.71°, P=0.629). After repositioning, the AT TORBI/LISA platform showed significantly higher misalignment degrees compared to AcrySof and TECNIS (Difference:6.63°;5.49°, P=0.009).

Conclusion: AcrySof TIOLs had a lower incidence of repositioning surgery comparing with AT TORBI/LISA and TECNIS, while AT TORBI/LISA TIOLs exhibited a higher degree of axis misalignment both before and after repositioning.

Background: Juvenile-onset open-angle glaucoma (JOAG) is a rare and refractory form of glaucoma, primarily characterized by structural abnormalities in the trabecular meshwork and Schlemm's canal. These abnormalities disrupt aqueous humor outflow, resulting in elevated intraocular pressure and progressive glaucomatous damage. Pharmacological and laser therapies are generally ineffective in managing JOAG. Surgical intervention, particularly Schlemm's canal surgery, is considered an optional component of its treatment.

Summary: This review comprehensively analyzes the advancement of Schlemm's canal surgery for JOAG, including ab externo and ab interno Schlemm's canal surgery.

Key messages: Schlemm's canal surgery is a procedure designed to enhance aqueous humor outflow by reducing resistance within the outflow pathway, offering a safe and effective option for treating JOAG. Recent advances in our understanding of JOAG pathogenesis, coupled with continuous improvements in surgical techniques, have ushered in a new era of "ab interno" and minimally invasive procedures. These procedures targeting the extensive trabecular meshwork may enhance therapeutic efficacy. However, prospective and comparative studies with larger sample sizes and extended follow-up periods are needed to validate the long-term safety and efficacy of these surgical methods in managing JOAG.

Background: Previous observational studies have suggested an association between vitamin D levels and the risk of cataracts. Whilst this correlation has been well reported, there is a lack of causal evidence.

Methods: We first conducted an observational study using UK Biobank (UKBB) data to explore the correlation between vitamin D levels and deficiency with incident cataract. To assess causality, we then performed both one-sample and two-sample Mendelian Randomisation (MR) analyses. The one-sample MR used genetic risk scores (GRS) reflecting a genetic predisposition to higher vitamin D levels and vitamin D deficiency, examining its association with incident cataract. The two-sample MR, publicly available summary statistics for vitamin D levels and deficiency were used to investigate their relationship with cataract. Sensitivity analyses using a UKBB meta-analysis for vitamin D in a two-sample MR and a gene-focused analysis using variants in genes with a known role in vitamin D metabolism.

Results: The observational analysis showed a statistically significant relationship between both vitamin D levels (OR = 0.998, ln(OR)SE = 3.23x10-4, p = 6.72x10-14) and deficiency (OR = 1.237, ln(OR)SE = 0.022, p = 9.05x10-23) with incident cataract risk. However, there was insufficient evidence to suggest an association between vitamin D supplementation and cataract risk (OR = 0.971, ln(OR)SE = 0.016, p = 0.057). Furthermore, no evidence was found in our one-sample MR analysis to suggest a causal relationship between vitamin D levels (OR = 1.001, ln(OR)SE = 0.002, p = 0.541) or vitamin D deficiency (OR = 1.095, ln(OR)SE = 0.145, p = 0.534) and incident cataract. The inverse variance weighted two-sample MR analysis also showed no evidence to suggest a causal association between vitamin D levels (IVW: OR = 1.122, 95% CI: 0.968-1.301, p = 0.125) or deficiency (IVW: OR= 0.987, 95% CI: 0.959-1.015, p = 0.344) and cataract risk, with consistent results observed using a multi-ethnic cataract cohort. Some evidence was observed between vitamin D levels and increasing cataract risk (Weighted median OR = 1.076, 95% CI: 1.002-1.156, p = 0.045), however, due to sample overlap between the exposure and outcome, datasets should be interpreted with caution.

Conclusion: Whilst we identified a correlative association between vitamin D levels and cataract, we found no robust evidence to support a causal relationship between vitamin D levels and deficiency with cataract risk.