Ophthalmic Research最新文献

Introduction: This study aimed to investigate the relationship between spectral domain optical coherence tomography (SD-OCT) structural findings and visual acuity in patients with retinitis pigmentosa (RP), with and without cystoid macular edema (CME), at baseline and one-year follow-up.

Methods: This retrospective chart review included 30 patients with RP treated at the University of Florida (UF) Health Eye Center from 2014 to 2020. Patient records were analyzed for SD-OCT structural features and visual acuity outcomes. Statistical analyses included descriptive statistics, χ² tests, independent t-tests, and Pearson's correlation tests. Main outcome measures were best corrected visual acuity (BCVA), presence of the ellipsoid zone (EZ) in the fovea and macula, central retinal thickness (CRT), total macular volume (TMV), and presence of an epiretinal membrane (ERM).

Results: The study included 30 patients (21 female, 9 male) with an average age of 46.83 ± 18.86 years (range, 10-80 years). The average follow-up period between visits was 11.9 ± 1.6 months (range, 9-15 months). Among the 60 eyes analyzed, 50% had CME. Eyes with CME had a greater CRT at the follow-up visit (p=0.029). No significant differences were found in BCVA or TMV between RP patients with and without CME. Correlation analyses revealed a significant relationship between CRT and BCVA at both visits (p=0.001, p=0.004) in RP patients without CME, but not in RP patients with CME. EZ foveal sparing consistently predicted BCVA outcomes (p<0.001) and CRT (p≤0.001) at both visits in RP patients with and without CME. Greater TMV at both visits (p=0.009, p=0.012) and the presence of an ERM at the follow-up visit (p=0.046) were significantly associated with a decline in BCVA between visits in RP patients without CME.

Conclusions: EZ foveal sparing is a significant predictor of visual acuity in RP patients regardless of the presence of CME. While CRT correlates with visual acuity in patients without CME, it does not predict outcomes in those with CME. TMV may serve as a marker for preclinical CME, and both increased TMV and ERM presence may predict visual decline in RP patients with undetectable CME on SD-OCT.

Introduction: The aim of the study was to evaluate functional and anatomical changes at 44 weeks follow up in patients with naïve neovascular age-related macular degeneration (nAMD) treated with faricimab intravitreal injections (IVIs).

Methods: Fifty-four eyes of 54 patients with naïve active macular neovascularization and nAMD were enrolled at the Ophthalmology Clinic of University "G. d'Annunzio", Chieti-Pescara, Italy. All patients were scheduled for faricimab IVI. Each patient underwent complete ophthalmic examination including best-corrected visual acuity (BCVA) using the Early Treatment Diabetic Retinopathy Study (ETDRS) charts and optical coherence tomography (OCT). All measurements were evaluated at baseline, at week 20 and then according to fixed retreatment interval up to week 44. Fluorescein angiography (FA) and indocyanine green angiography (ICGA) were also performed at baseline. Main outcome measures were changes in best-corrected visual acuity (BCVA), central macular thickness (CMT), subfoveal choroidal thickness (SFCT), intraretinal fluid (IRF) presence, subfoveal subretinal fluid (SSRF) presence and thickness, pigment epithelial detachments (PEDs) presence and maximum height (PED-MH).

Results: BCVA improved and CMT reduced significantly from baseline to week 44 (p=0.002 and p=0.020, respectively) in the overall sample with a higher significant improvement from baseline to week 20 (p<0.001 for both parameters) and no additional significant improvement from week 20 to week 44 in the overall sample (p=0.348 and p=0.146, respectively). At week 20, 72.3% of patients were in the Q12/ Q16 interval. Patients in q8 interval showed significant improvement of BCVA (p < 0.001) and significant reduction of CMT (p=0.008) from baseline to week 44 respectively. PED-MH as well showed a significant reduction from baseline to week 44 (p <0.001). Patients in Q12 interval showed significant improvement of BCVA (p=0.030) and significant reduction of CMT, SFCT and PED-MH from baseline to week 36 (p<0.001). Patients in Q16 interval show significant reduction of BCVA during follow up (p=0.026). CMT, SFCT and PED-MH were significantly reduced from baseline to week 44 (p < 0.001).

Conclusion: Faricimab showed efficacy in the treatment of naïve nAMD patients with an improvement of many anatomical and functional parameters at 44 weeks allowing to maintain a treatment regimen for most patients equal to or greater than 12 weeks.

Introduction: Diabetes mellitus (DM) is frequently associated with microvascular complications, including diabetic peripheral neuropathy (DPN). The cornea, one of the most densely innervated tissues in the body, has been proposed as a surrogate marker for small fiber neuropathy. Patients with DM often present with ocular surface disease (OSD) and corneal sensitivity impairment, but the relationship between DPN, ocular surface alterations, and inflammatory biomarkers remains unclear. This study aimed to evaluate ocular surface parameters in patients with type 2 DM and to investigate associations among DPN, corneal sensitivity, ocular surface inflammation (matrix metalloproteinase-9, MMP-9), and indicators of dry eye disease (DED).

Methods: In this cross-sectional observational study, 158 eyes of 79 patients with type 2 DM were categorized based on the presence or absence of DPN, diagnosed via electromyography. Corneal sensitivity was evaluated using the Brill esthesiometer, and tear MMP-9 levels were assessed with the InflammaDry test. Additional assessments included the Ocular Surface Disease Index (OSDI), tear osmolarity, Schirmer test, non-invasive tear break-up time (NIBUT), and meibography. Corneal impairment was defined as esthesiometry levels 4-6 or pressure thresholds ≥8 mbar in either eye.

Results: Patients with DPN exhibited significantly reduced corneal sensitivity (6.98 ± 2.25 mbar vs. 5.62 ± 2.53 mbar; 𝑝 = 0.014) and higher OSDI scores (median 26 vs. 10; 𝑝 < 0.001). MMP-9 positivity was more common in patients with corneal involvement (81.8% vs. 54.3%; 𝑝 = 0.0215). A significant inverse correlation was observed between tear osmolarity and corneal sensitivity (r = -0.182, 𝑝 = 0.022). Multivariable regression showed that both DPN (β = 1.20) and MMP-9 positivity (β = 1.24) were independently associated with reduced sensitivity.

Conclusions: Reduced corneal sensitivity is significantly associated with DPN, elevated tear osmolarity, and MMP-9 expression. Ocular surface evaluation may serve as a non-invasive tool for early detection of diabetic neuropathy.

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 s).

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.

Introduction: 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 ≥ -3.00D 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. 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 15 mm Hg to 9 mm Hg after ocular massage. High myopia demonstrated a mild enlargement of the SC area (from 10,655.60 ± 4,362.02 µm2 to 12,632.40 ± 4,393.19 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 8,540.71 ± 3,905.98 µm2 to 11,686.53 ± 4,586.37 µm2, p = 0.001) and SC length (from 240.47 ± 69.96 µm to 280.40 ± 59.37 µm, p = 0.041).

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

Introduction: 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 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 rate (ASDR) and prevalence rate 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 age-period-cohort 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).

Conclusion: 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: 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.