Ophthalmology and Therapy最新文献

Introduction: Persistent corneal epithelial defects (PCEDs) occur when conditions like dry eye disease (DED), neurotrophic keratitis (NK), and limbal stem cell deficiency impair corneal healing, leading to risks of infection, scarring, or perforation. Decellularized, dehydrated pure amniotic membrane basement membrane (AMBM) supports healing by promoting cell adhesion, growth, and inflammation reduction. Eyelid pressure patching helps stabilize the AMBM, protects the cornea, and enhances its therapeutic effects.

Methods: This retrospective study analyzed 144 eyes treated with either a single-layer or three-layer decellularized AMBM combined with a 24-h eyelid pressure patch.

Results: Of the patients included, 90% received a single-layer AMBM and 10% a three-layer AMBM. In the single-layer group, 100% of cases showed complete healing and AMBM dissolution. In the three-layer group, 100% showed corneal staining improvement, but 20-30% of the AMBM remained undissolved. No patients reported experiencing pain, discomfort, or infection.

Conclusions: Combining eyelid pressure patching with amniotic membrane treatment is a safe and effective approach for healing persistent corneal epithelial defects.

Introduction: Lotilaner ophthalmic solution (0.25%) is the first United States Food and Drug Administration (US FDA)-approved drug for treating Demodex blepharitis. In pivotal trials, it was found to be well tolerated and demonstrated a significant reduction in collarettes and mite density after a 6-week treatment regimen. This study aimed to report the safety and efficacy profile of lotilaner ophthalmic solution (0.25%) from a pooled analysis of two pivotal trials in patients with Demodex blepharitis.

Methods: Pooled data were analyzed from two randomized, double-masked, vehicle-controlled clinical trials [phase 2b/3 Saturn-1 (NCT04475432) and phase 3 Saturn-2 (NCT04784091)] in which patients with Demodex blepharitis were randomly assigned in a 1:1 ratio to receive either lotilaner ophthalmic solution (0.25%) (study group) or the vehicle formulation without lotilaner (control group), twice daily for 6 weeks. The outcome measures were the proportion of patients with 0-2 collarettes (grade 0 collarettes), mite eradication, erythema cure, and the proportion of patients with ≤ 10 collarettes (grade 0 or 1 collarettes) at day 43.

Results: Overall, 833 participants were randomized to receive either the study drug (N = 415) or vehicle (N = 418). On day 43, 49.8% of patients in the study group vs. 9.9% in the control group (p < 0.0001) had collarette grade 0 (0-2 collarettes). A reduction to ≤ 10 collarettes (grade 0 or 1 collarettes) was achieved in 85.1% of patients in study group vs. 28.0% in control group (p < 0.0001). The proportion of patients achieving mite eradication (60.2% vs. 16.1%, p < 0.0001) and erythema cure (24.9% vs. 7.9%, p < 0.0001) were also statistically significantly higher in the study group compared to the control group. The rates of adverse events were low in both studies, with no serious drug-related ocular adverse events reported. As many as 92% of patients rated the study drop as neutral to very comfortable.

Conclusions: Twice-daily treatment with lotilaner ophthalmic solution (0.25%) for 6 weeks demonstrated statistical significance for all outcome measures compared to the vehicle control, with low rates of adverse events and a high rate of drop comfort.

Introduction: Treatment burden of anti-vascular endothelial growth factor (VEGF) therapy for neovascular age-related macular degeneration (AMD) can be reduced with the Observe-and-Plan (O&P) regimen, which allows for an individualized treatment while reducing the number of injections and assessment visits. In this study, we evaluate detailed characteristics of treatment interval adjustment through individual follow-ups and evaluate adherence to the O&P regimen in a real-world setting in one of the largest centers in Europe.

Methods: This was a retrospective cohort study of treatment-naïve eyes with neovascular AMD that were treated with intravitreal aflibercept 2 mg in an O&P regimen who had persisting exudation after completion of loading dose. We evaluated decisions on adjustment of treatment intervals and adherence to the O&P regimen from a total of 5 follow-up visits. Data from visits and decision on treatment intervals were extracted from a treatment database.

Results: A total of 561 eyes were eligible for this study. Treatment intervals gradually increased from a 4-weeks interval (loading dose) to a wide distribution of intervals from 4-weeks to 12-weeks, and at the 5th follow-up 24.9% were followed without any treatment. In total, 209 eyes (49.5%) at the 5th follow-up (of 422 eyes present at the 5th follow-up) adhered to the treatment algorithm.

Conclusion: Aflibercept 2 mg in an O&P treatment regimen leads to a variety of treatment intervals, and some eyes may be overtreated. An important proportion of eyes deviate from the intended O&P treatment regimen. Our study contributes to understanding real-world implications of personalized treatment regimens.

Introduction: This retrospective, consecutive, real-world case series assessed the efficacy and safety of third-generation trabecular micro-bypass stent implantation (iStent infinite) with phacoemulsification in patients with mild-to-moderate primary open-angle glaucoma (POAG).

Methods: Patients underwent phacoemulsification combined with implantation of iStent infinite (containing three stents) by a single U.S. glaucoma surgeon. Outcomes through 12 months included mean intraocular pressure (IOP) and medications; proportions of eyes with IOP ≤ 18 mmHg, ≤ 15 mmHg, or ≤ 12 mmHg; proportions of eyes on 0, 1, 2, or ≥ 3 topical glaucoma medications; adverse events; and secondary glaucoma procedures. Data are presented for the observed cohort of all available eyes at each time point and the consistent cohort of eyes with data at 12 months postoperative.

Results: A total of 121 eyes with mild (66.1%) or moderate (33.9%) POAG underwent iStent infinite implantation between February 2023 and June 2024. In eyes with 12-month follow-up data (n = 32), mean IOP reduced from 18.1 ± 3.3 mmHg preoperatively to 13.8 ± 3.4 mmHg at 12 months (23.8% reduction, p < 0.001), while mean number of medications reduced from 1.38 ± 0.91 to 1.06 ± 1.13 medications (23.2% reduction, p = 0.023). The proportions of eyes achieving IOP ≤ 18/15/12 mmHg increased from 53.1%/21.9%/3.1% preoperatively to 87.5%/75.0%/43.8% at 12 months, respectively (all p < 0.01). Adverse events were largely mild and transient; three eyes (< 3%) had secondary laser or micro-invasive glaucoma interventions due to IOP and/or medications above goal.

Conclusions: iStent infinite implantation with cataract surgery resulted in clinically and statistically significant IOP and medication reductions through 12 months postoperative, with favorable safety. This cohort constitutes one of the first and largest published datasets for this device in combination with cataract surgery in real-world usage.

Introduction: Artificial tear substitutes are key elements in the first-line treatment of dry eye disease (DED). We hypothesized that GlicoPro^®, a new multimolecular complex based on proteins, sulfured and unsulfured glycosaminoglycans and opiorphin, was able to significantly improve the effect of hydroxypropyl-methylcellulose (HPMC) eyedrops in treating DED.

Methods: We performed an in vitro experiment and a clinical study, comparing an HPMC + GlicoPro^®-based to an HPMC-based ophthalmic formulation (similar kinematic viscosity and comparable HPMC concentration). An in vitro dry eye model was established by inducing hyperosmolarity in the base medium of human corneal epithelial cells HCE-2. After treatment with ophthalmic formulations, the expression levels of inflammatory cytokines and enzymes (IL-20, IL-1β, TNF-α, IL-6, IL-8, MMP-9, and MCP-1) was measured by real-time polymerase chain reaction. Moreover, we performed a single-blind randomized 1:1 clinical trial, aimed to compare the efficacy of the two formulations instilled four times per day (QID), in treating mild-to-moderate DED. Symptoms (Ocular Surface Disease Index and Symptom Assessment iN Dry Eye), clinical signs, and ocular surface imaging data were assessed at baseline and after 1 and 3 months of treatment.

Results: In vitro experiment: under hyperosmotic conditions, corneal epithelial cells upregulated the expression of inflammatory cytokines IL-20, IL-1β, TNF-α, IL-6, and IL-8. Treatment with HPMC + GlicoPro^® significantly decreased the expression of all inflammatory markers tested, including cytokines, MMP-9, and MCP-1 (P < 0.05).

Clinical study: the HPMC + GlicoPro^® formulation showed a significantly higher effect in improving symptoms (overall treatment effect: P < 0.001), tear film stability, and markers of inflammation on corneal confocal microscopy (P < 0.01).

Conclusions: Both in vitro and clinical data provided evidence supporting the role of GlicoPro^® in improving the effect of HPMC in DED treatment.

Clinical trial registration: NCT06726525.

Introduction: Persistent fetal vasculature (PFV) is a congenital anomaly associated with significant surgical challenges, including a high risk of postoperative retinal detachment (RD). This study aimed to evaluate the impact of surgical approach and axial length (AL) on RD risk and visual outcomes in pediatric PFV management.

Methods: A retrospective cohort study was conducted involving 76 eyes of 74 patients who underwent cataract surgery for PFV between 2014 and 2022. Patients were categorized by RD status postoperatively (14 with RD, 62 without RD). Key predictors, including surgical approach (corneal vs. pars plicata), AL, and age at surgery, were analyzed. The primary outcomes were RD incidence and final best-corrected visual acuity (BCVA).

Results: Compared to the pars plicata approach, the corneal approach was associated with a significantly lower risk of RD, as indicated by a multivariate odds ratio of 0.08 (95% CI 0.01-0.6, P = 0.011). A shorter AL increased the risk of RD (median 17 vs. 20 mm, P = 0.002). The RD group showed poorer visual outcomes (P < 0.001), with a 71% loss of light perception. Surgery before 3 months improved outcomes, regardless of RD. Visible ciliary processes were strongly correlated with RD (P < 0.001).

Conclusions: Corneal surgical approach and longer AL are associated with a lower RD risk in PFV cataract surgery. Early intervention and thorough preoperative assessment of the AL and ciliary processes are crucial for optimal outcomes.

Neovascular age-related macular degeneration (nAMD) is associated with considerable quality of life and economic burden. nAMD is characterized by pathological neovascularization, leading to the accumulation of retinal fluid. Intraretinal fluid (IRF) is a major contributor to vision loss and may predict response to treatment. In contrast, the role of subretinal fluid (SRF) is less clear. Nevertheless, complete resolution of retinal fluid accumulation is often stated to be a key goal of therapy for nAMD, even though some eyes may never achieve a fluid-free macula despite regular anti-vascular endothelial growth factor treatment. In this article, we review the current literature regarding the role of retinal fluid in nAMD disease outcomes and assess whether and when it may be beneficial to leave retinal fluid untreated. In this context, we highlight the importance of correctly identifying retinal fluid types in nAMD and avoiding confusion with other optical coherence tomography signs that may respond differently to therapy, such as subretinal pseudocysts. Current evidence shows that IRF is associated with poor outcomes and an increased risk of developing atrophy and fibrosis; resolution of this retinal fluid type should remain a treatment target. However, the literature around SRF indicates that low levels of this fluid type, potentially up to 150-200 µm in thickness, may be tolerated with minimal impact on vision, and that SRF could be protective against the development and progression of macular atrophy and fibrosis. Although mild SRF may be protective in nAMD, cause and effect between SRF and reduced or slowed atrophy has not yet been proven and requires further research. Treatment should be given for the most aggressive component; when both IRF and SRF are present, treatment should be given for IRF.

Introduction: This study aimed to compare changes in retinal oxygen saturation 1 month after femtosecond-assisted laser in situ keratomileusis (FS-LASIK) in Chinese adults with myopia using retinal oximetry.

Methods: In this prospective, observational, single-center cohort study, Chinese adults aged 18-45 years with myopia were categorized into four groups according to spherical equivalent (SE), with 66 eyes characterized as low myopia (LM -3.00D < SE ≤ -0.50D), 68 eyes as moderate myopia (MM -6.00D < SE ≤ -3.00D), 68 eyes as high myopia (HM -9.00D < SE ≤ -6.00D), and 65 eyes as super-high myopia (SHM: SE ≤ -9.00D). The following were measured before and 1 month after FS-LASIK: SE, intraocular pressure (IOP), average keratometry (Km), and axial length (AL). Other ocular biological parameters included retinal arterial oxygen saturation (SaO₂) and retinal venous oxygen saturation (SvO₂); parameter difference values are expressed as ∆.

Results: Of the 267 participants, 63.30% were female and 36.70% were male. The mean SE, AL, SaO₂, and SvO₂ were -5.93 ± 3.24 D, 26.01 ± 1.35 mm, 93.49% ± 1.67%, and 62.97% ± 4.52%, respectively. Before FS-LASIK, SaO₂ was significantly correlated with AL and SE (r_s = -0.305, P < 0.001; r_s = 0.385, P < 0.001). Significant differences were found in SaO₂ across myopia categories (P < 0.001). The changes in the retinal arterial oxygen saturation decreased significantly after FS-LASIK (F = 24.948, P < 0.001). After surgery, SaO₂ demonstrated a statistically significant but weak negative relationship with refractive correction (ΔSE) (r_s = -0.380, P < 0.001) and axial length (r_s = -0.404, P < 0.001), a significant but weak positive correlation with average keratometry cutting value (ΔKm) (r_s = 0.354, P < 0.001), and no correlation with the change in IOP (ΔIOP) (P > 0.05).

Conclusion: Ruling out the influence of refractive error, SaO₂ was significantly decreased 1 month after FS-LASIK, while there was no significant change in SvO₂. We conjecture that retinal amplification may affect differences in retinal oxygen saturation.

The prevailing narrative in scientific literature has long overemphasized the role of ocular axes in intraocular lens (IOL) implantation, perpetuating misconceptions that have led to unnecessary exclusions of patients. Historical assumptions, coupled with inconsistent terminology and statistical inaccuracies, have muddled clinical decision-making. This review delves into these misconceptions, offering a critical reassessment of their relevance. Drawing from a non-systematic search across PubMed, the IOLEvidence App Database, and additional sources through snowballing, the review includes diverse studies exploring the relationship between ocular axes (angles, chords, kappa, alpha, lens, …) and IOL implantation. The findings reveal widespread confusion in terminology, particularly the interchangeable use of terms like 'angles' and 'chords', and highlight device-specific variability in parameters such as Chord-mu, Chord-alpha, and Chord-lens. Despite these inconsistencies, no robust evidence supports using these measures as grounds for excluding patients from IOL procedures. Interestingly, postoperative IOL centration (Chord-iol) emerged as a more critical factor for visual outcomes than preoperative ocular axes. The evidence suggests that values for Chord-mu, Chord-alpha, and Chord-lens should prompt further evaluation of atypical cases but are not reliable exclusion criteria. Moreover, a shift in focus toward aligning the IOL slightly temporal to the vertex normal appears to optimize visual acuity and minimize photic phenomena, challenging the established paradigm of knowledge about IOL centration.

Introduction: In clinical practice, intravitreal anti-vascular endothelial growth factor (anti-VEGF) injection intervals for patients with neovascular age-related macular degeneration (nAMD) are based on disease activity, with active or recurrent disease requiring more frequent injections. Injection interval modification criteria differ from those used in clinical trials, thereby potentially affecting treatment outcomes. This analysis evaluated the potential impact of applying disease activity criteria from recent clinical trials (TENAYA/LUCERNE; HAWK/HARRIER; PULSAR) on the decision to extend injection intervals in real-world patients commenced on faricimab after the loading phase of treatment and at 12 months.

Methods: Data were analysed from 105 treatment-naïve patients with nAMD who received anti-VEGF injections at Moorfields Eye Hospital. Disease activity criteria from TENAYA/LUCERNE, HAWK/HARRIER and PULSAR clinical trials were applied to determine the hypothetical impact on the decision to modify injection intervals at week 12 (fourth injection) and 12-month real-world clinic visits.

Results: At 12 weeks, 79% of patients had injection intervals extended in clinical practice compared to 80% when applying hypothetical TENAYA/LUCERNE disease activity criteria; 77% using HAWK/HARRIER and 96% using PULSAR. There was agreement between clinical practice and all clinical trials in 60% of eyes, and no agreement in 13%. At 12 months, fewer patients were inactive, with 55% of eyes quiescent in clinical practice, 58% when applying TENAYA/LUCERNE criteria and 67% using HAWK/HARRIER. Application of PULSAR disease activity criteria showed 96% of patients were classed as inactive. 34% of eyes showed agreement in disease activity status between clinical practice and all clinical trials at 12 months, with no agreement in 20%.

Conclusions: Applying disease activity criteria from clinical trials to clinical practice can have a significant impact on hypothetical anti-VEGF injection intervals. Consideration should be paid to which criteria are used in real-world practice to help achieve treatment burden reductions and optimal treatment outcomes seen in clinical trials.