Ophthalmology and Therapy最新文献

Introduction: To evaluate the early outcomes of aflibercept 8 mg (afl8) treatment in patients with neovascular age-related macular degeneration (nAMD) previously treated with aflibercept 2 mg (afl2).

Methods: A retrospective, observational, monocentric Swiss study. Patients with nAMD who had received ≥ 3 consecutive afl2 injections and switched to afl8 because of persistent or recurrent fluids, or to extend treatment intervals, were included in the study. All patients started a loading phase of 3-monthly afl8 injections, followed by a treat-and-extend regimen. Outcome measures included changes in best-corrected visual acuity (BCVA), maximal pigment epithelial detachment (PED) height, central subfield thickness (CST), optical coherence tomography (OCT) biomarkers quantified using artificial intelligence, and treatment intervals until month 6.

Results: Fifty-two eyes of 44 patients who concluded the loading phase were included in this analysis. Mean age was 80.2 ± 8.5 years; 73% of patients were females. At month 6, BCVA was unchanged, PED and CST height experienced a significant decrease by - 18.5 ± 12.9 μm (p = 0.0005) and - 14.0 ± 3.5 μm (p = 0.0042), respectively. Volumes of intraretinal fluid (IRF), subretinal fluid (SRF), and PED decreased (IRF: 4.4 ± 15.6-3.8 nl; SRF: 15.7 ± 35.7-10.3 ± 34.0 nl; PED: 268.2 ± 423.2-252.2 ± 484.1 nl). Mean treatment intervals increased by 1.7 ± 0.5 weeks from the last assigned interval and by 0.6 ± 0.2 weeks from previous maximal fluid-free intervals after switching (p = 0.0005 and p = 0.18, respectively). One mild vitritis was observed and resolved with vitrectomy and topical drops without decreased visual acuity.

Conclusion: Our real-world study supports the potential short-term benefits of afl8 in improving anatomical and durability outcomes in patients with recurrent nAMD. These findings also highlight the added value of data-driven evaluations. Long-term studies are needed to confirm the effectiveness and durability of afl8 in this population.

In 2011, meibomian gland dysfunction (MGD) was officially recognized as a condition that necessitated treatment with the goal of improving ocular symptoms. This was a tipping point in the understanding of MGD and the need for treatment. After 2011, there was an exponential increase in the research of MGD and treatment modalities. This commentary aims to provide information for clinicians to understand the value of in-office treatments with LipiFlow and the inherent differences in efficacy, patient/doctor experience, compliance, and safety of other treatment modalities. Also, the aim of this commentary is to describe how LipiFlow Thermal Pulsation System contributed to the evolution of MGD management by transforming therapeutic gland expression from an underutilized intervention into a widely adopted, evidence-based standard of care.

Introduction: Diabetic retinopathy (DR) is a leading cause of preventable blindness and is linked to excess mortality. Systemic inflammation plays a central role in DR pathogenesis, and the systemic immune-inflammation index (SII) has emerged as a novel marker associated with adverse outcomes. However, its prognostic value in DR remains unclear.

Methods: Using nationally representative data from National Health and Nutrition Examination Survey 2005-2018, we investigated the association between the systemic immune-inflammation index (SII) and all-cause mortality among 209 US adults aged ≥ 50 years with DR. Mortality status was ascertained through linkage to the National Death Index through 2019.

Results: Weighted Cox regression models showed that higher SII was modestly but significantly associated with increased mortality risk (HR = 1.01, 95% CI 1.00-1.002, p < 0.001), with restricted cubic splines indicating a non-linear relationship. SII exhibited moderate predictive ability for mortality, with AUCs declining from 0.762 at 24 months to 0.576 at 60 months. Subgroup analyses suggested that the association between SII and mortality persisted across most demographic and clinical strata.

Conclusion: These findings suggest that elevated systemic immune inflammation may independently predict long-term mortality risk in adults with DR, highlighting its potential value as a prognostic biomarker beyond traditional risk factors.

Introduction: Dry eye disease (DED) is a common comorbidity in patients undergoing cataract surgery. Perfluorohexyloctane ophthalmic solution (PFHO) forms a protective layer on the tear film surface to reduce evaporation and is approved for treatment of signs and symptoms of DED. Because PFHO has a long ocular surface residence time, it was of interest to assess whether PFHO interfered with preoperative biometry and keratometry measurements to affect postoperative refractive accuracy in patients undergoing cataract surgery. This study evaluated the perioperative use of PFHO in patients undergoing cataract surgery.

Methods: This phase 4, multicenter, open-label, single-arm study enrolled patients with DED who were candidates for phacoemulsification with posterior chamber intraocular lens (IOL) implantation. Patients instilled PFHO bilaterally four times daily for 30 days preoperatively and received a second 30-day PFHO treatment approximately 1 month after surgery. The primary endpoint was the mean difference in absolute deviations between the manifest refraction spherical equivalent and predicted refractive error.

Results: Ninety-seven patients were enrolled (mean age: 68.6 years; female: 75.3%). The mean difference in absolute deviations between manifest refraction and predicted refractive error was -0.027 ± 0.167 D (p = 0.1385). The difference in predicted refractive error at baseline versus post-PFHO treatment was within ± 0.3 D for 94.2% of study eyes. More patients had a calculated IOL power within ± 0.50 D of the correct IOL power post-PFHO treatment than pre-PFHO (83.7% vs. 72.1%). Treatment with PFHO significantly improved DED signs and symptoms, including total and central corneal fluorescein staining, eye dryness, and Ocular Surface Disease Index scores, before and after cataract surgery (p < 0.0001 for all). The percentage of patients with best-corrected visual acuity of 20/20 or better was 86.0% at first postsurgical assessment and 91.8% after 30 days of subsequent PFHO treatment. Two adverse events were considered related to treatment (mild eye pruritus and mild noninfectious conjunctivitis).

Conclusions: In patients with DED undergoing cataract surgery, PFHO did not affect the accuracy of preoperative biometry and keratometry measurements or the predicted refractive error. Patients experienced significant reductions in signs and symptoms of DED.

Trial registration: ClinicalTrials.gov identifier, NCT06346340.

Introduction: Age-related cataracts are the leading cause of blindness worldwide, and phacoemulsification is the standard surgical treatment. Optical coherence tomography angiography (OCTA) enables non-invasive assessment of these microvascular changes. However, findings from individual studies remain inconsistent. This systematic review aimed to determine potential vascular changes in the macula and optic nerve using OCTA following phacoemulsification.

Methods: This review was developed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Three different databases-Scopus, PubMed and Web of Science-were searched for relevant studies published from 2015 to June 2025. Study quality was assessed using the Study Quality Assessment Tools developed by the National Heart, Lung, and Blood Institute (NHLBI). Among the identified studies, 21 were included in the review. All included studies assessed the changes in the retinal vascular network following phacoemulsification.

Results: The quality of most of the studies was moderate to high. Most studies reported an increase in vascular density in various vascular plexuses, though these changes varied by retinal region, vascular plexus, and follow-up duration. A reduction in the foveal avascular zone (FAZ) was also observed. These changes may be attributed to post-operative inflammation, decreased intraocular pressure (IOP) and increased retinal metabolism.

Conclusions: The results from this systematic review reveal that most included studies reported an increase in vascular density in various plexuses. These changes varied depending on retinal region, specific plexus, and follow-up duration. Additionally, a reduction in the FAZ was commonly observed. Patient-specific factors, such as diabetes and myopia, were associated with variability in vascular response.

Introduction: This study aims to evaluate the efficacy, safety, and immunogenicity of ZRC-3285 (aflibercept biosimilar) with Eylea^® (aflibercept) in patients with neovascular (wet) age-related macular degeneration (nAMD).

Methods: This phase III, multicenter, double-blind study was conducted across 27 sites in India and randomized (2:1) patients with nAMD into either the test aflibercept (ZRC-3285, Zydus Lifesciences Ltd.) or Eylea^® (Regeneron Pharmaceuticals, Inc.) groups. All 184 enrolled patients (122 and 62 in the ZRC-3285 and Eylea^® groups, respectively) were included in the modified intend-to-treat (mITT) population. ZRC-3285 or Eylea^® was administered by intravitreal injection at a dose of 2 mg (0.05 mL) on days 1, 29, and 57. The primary objective was to assess non-inferiority of ZRC-3285 versus Eylea^® in treating nAMD and was evaluated by determining the proportion of patients who lose fewer than 15 letters from baseline visual acuity over 12 weeks using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Secondary objectives included comparison of additional efficacy outcomes, immunogenicity, and safety.

Results: Over 12 weeks, all patients in the ZRC-3285 (122, 100%) and Eylea^® (62, 100%) groups showed loss of fewer than 15 letters, demonstrating non-inferiority [95% confidence interval (CI) not evaluable (NE); p = NE)] of ZRC-3285 to Eylea^®. The proportion of patients who gained more than 15 letters in best corrected visual acuity (BCVA) over 12 weeks and the mean changes in BCVA, choroidal neovascularization (CNV), and central retinal thickness (CRT) were similar in both arms.

Conclusion: Efficacy, immunogenicity, and safety profiles of ZRC-3285 were found to be similar to those of Eylea^®.

Trial registration: Clinical trial Registry of India (CTRI): CTRI/2023/09/057655 [Registered on 14/09/2023].

Introduction: A retrospective analysis was performed to determine if a glueless, sutureless surgical technique utilizing a triple-layer dehydrated, decellularized amniotic basement membrane tissue, combined with short exposure to mitomycin‑C (MMC), can reduce recurrence and complications after pterygium surgery. Surgical excision remains the mainstay of treatment when symptoms such as vision impairment, foreign body sensation, or cosmetic concerns arise. Wide variation in recurrence rates reflects differences in patient populations, follow-up duration, surgical technique nuances, and definition of recurrence. A dehydrated triple-layer decellularized amniotic basement membrane tissue has unique attributes compared to other amniotic membrane tissue (AMT). Decellularization removes the pro-inflammatory chorion and residual donor cellular debris, thereby reducing immunogenicity while preserving extracellular matrix proteins such as collagen, fibronectin, and laminin, which produce anti-inflammatory cytokines and growth factors, promoting epithelial adhesion and migration. In pterygium excision, decellularized basement membrane may contribute to faster, more comfortable recovery, improved cosmesis, and a reduced risk of recurrence.

Methods: A total of 34 eyes from 33 patients underwent pterygium excision using dehydrated, three-layer decellularized basement membrane.

Results: All patients reported minimal postoperative discomfort, and the operative eyes were relatively quiet with minimal subconjunctival injection. Recurrence was 0% (0/34 eyes) at a mean follow-up of 394 days (range, 174-668). In addition, no pyogenic granuloma, infections, dellen, or melts occurred.

Conclusions: Compared with traditional AMT and conjunctival autograft (CAG) methods using glue or sutures, this approach not only reduces operative time, postoperative discomfort, postoperative visits, and topical steroids but also saves costs without compromising outcomes.

Introduction: Consensual ophthalmotonic reaction (COR) refers to consensual intraocular pressure (IOP) change in the fellow eye following alteration of IOP in one eye. The study aimed to investigate COR and the magnitude of consensual IOP change after unilateral glaucoma surgery.

Methods: We analyzed 356 eyes from 293 patients who underwent unilateral trabeculectomy, bleb needling, trabectome, or microcatheter-assisted trabeculectomy (MAT) between 2016 and 2022. In the fellow eye, baseline IOP was compared with IOP at 1 day, 1 week, 1 months, 3 months, and 6 months postoperatively. Fellow eyes with IOP change exceeding 4 mmHg or 20% increase from baseline were defined as fellow eyes with COR. Univariate and multivariate analysis were performed to identify influencing factors associated with COR and IOP change in the fellow eye.

Results: In fellow eyes, IOP was 18.3 ± 7.3 mmHg at baseline, significantly increasing to 19.3 ± 7.5 mmHg at postoperative day 1 (POD1) and remaining stable at other time points, with a COR incidence of 40.7% (145 eyes) at POD1. Univariate and multivariate analysis identified preoperative use of α₂-receptor agonists in the fellow eye as a significant protective factor against COR after trabeculectomy and bleb needling. We also identified that key influencing factors for COR varied by surgery type: pseudophakia in the fellow eye was protective in trabeculectomy, history of diabetes was a risk factor for bleb needling, and prior glaucoma surgery predicted COR after trabectome. Greater IOP reduction in the operated eye correlated with a larger consensual IOP rise following minimally invasive glaucoma surgery (MIGS) procedures.

Conclusions: Collectively, our findings suggest that COR is a common early postoperative phenomenon regardless of glaucoma surgery type, and the preoperative use of α₂-receptor agonists is associated with a lower incidence of COR. Therefore, it is essential to monitor IOP in the fellow eye perioperatively.

Introduction: Rapid pathogen identification in severe infectious keratitis is critical for targeted therapy to prevent vision loss, but conventional methods are slow and only moderately sensitive. Our objective was to evaluate the diagnostic accuracy and turnaround time of combined FilmArray^® Meningitis-Encephalitis (ME)/Blood Culture Identification (BCID) multiplex polymerase chain reaction (PCR) panels versus standard microbiology (culture + pathogen-specific PCR) in severe infectious keratitis.

Methods: This was a prospective pilot diagnostic study at a French tertiary center (July 2023-April 2025) including 23 adults with severe microbial keratitis. Corneal samples were analyzed using both conventional microbiological testing (culture and pathogen-specific PCR) and rapid multiplex PCR with the FilmArray^® ME and BCID panels. Primary outcomes were diagnostic agreement between the FilmArray^® multiplex PCR system and conventional microbiological methods, measured by Cohen's κ coefficient. Turnaround times were compared using the Wilcoxon signed-rank test.

Results: Among 23 adult patients (mean age 61.0 [SD 21.2] years, range 24-99; 13 female patients [56.5%]), conventional microbiology identified pathogens in 16 cases (69.5%) versus 15 (65.2%) with multiplex PCR. Overall diagnostic agreement was moderate (κ = 0.50; 95% CI, 0.25-0.76), with perfect concordance (12/12, 100%) for monomicrobial infections detected by both methods. Multiplex PCR significantly reduced mean time to identification (2 h [no variation]) versus conventional methods (102 [SD 42.5] h; P < .001). Both methods were negative in six patients (26.1%) with comparable clinical severity.

Conclusion: Combined FilmArray^® ME/BCID panels demonstrated complete concordance with standard microbiology for monomicrobial keratitis and reduced turnaround times by > 100 h. This strategy may accelerate targeted therapy, potentially improving visual outcomes.

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.