Ophthalmology and Therapy最新文献

Introduction: Topical atropine is widely used for myopia control in children, with proven efficacy in slowing myopia progression. However, concerns remain regarding its potential effects on intraocular pressure (IOP), particularly with long-term use. This study aimed to evaluate the longitudinal effects of topical atropine on IOP in children with myopia.

Methods: This retrospective, longitudinal study enrolled children using 0.125% atropine to control myopia progression and atropine non-users. IOP was measured repeatedly before and during treatment. RTVue optical coherence tomography (OCT) measured retinal nerve fiber layer (RNFL) and ganglion cell complex (GCC) thickness. Multilevel models assessed IOP changes by adjusting age, sex, spherical equivalent, central corneal thickness, and baseline IOP.

Results: A total of 188 patients (376 eyes) in the atropine group and 188 patients (376 eyes) in the control group were included. There were 86 boys (46%) aged 8.0 ± 2.5 years. Patients in the atropine group were more myopic (-1.17 ± 1.40 versus 0.73 ± 1.83 D, P < 0.001). The central corneal thickness and baseline IOP (atropine: 17.6 ± 3.0 mmHg; control: 17.2 ± 3.6 mmHg) were similar. Over a follow-up of 18.6 months (atropine, 19.3 months; control, 18.0 months), the final IOP was higher in the atropine group (18.3 ± 3.6 versus 16.7 ± 3.2 mmHg, P < 0.001). In the multivariable multilevel models, atropine was associated with an additional 0.51-mmHg increase (95% confidence interval [CI] 0.36-0.67, P = 0.001) in IOP per year when adjusted for sex, age, central corneal thickness, spherical equivalent, and baseline IOP. RNFL (104.0 ± 8.8 versus 102.6 ± 7.5 µm, P = 0.475) and GCC thickness (98.1 ± 5.6 versus 96.7 ± 5.8 µm, P = 0.270) showed no significant differences between groups.

Conclusions: Atropine use for myopia control in children was associated with a modest IOP increase without apparent impact on RNFL. Regular IOP monitoring is advisable.

Introduction: Neovascular age-related macular degeneration (nAMD) is one of the leading causes of vision loss, often requiring frequent injections. Our aim is to report the early outcomes of intravitreal aflibercept (IVA) 8 mg treatment in naïve patients with nAMD.

Methods: An observational, retrospective, monocentric study was conducted at Swiss Visio Montchoisi, Lausanne, Switzerland. A total of 51 eyes of 48 patients with naïve macular neovascularization (MNV) secondary to AMD received a loading phase of three-monthly IVA followed by a monthly observational phase until fluid recurrence. At each visit, all patients had a full ophthalmological exam, including spectral-domain optical coherence tomography (SD-OCT), which was analysed manually and with artificial intelligence (AI). The main outcomes were best-corrected visual acuity (BCVA), central subfield thickness (CST), maximal pigment epithelial detachment (PED) height, presence or absence of intraretinal fluid (IRF) and subretinal fluid (SRF) on SD-OCT, and mean volumetric changes in IRF, SFR, and PED using AI at baseline and month 1, 2, 3, and 6.

Results: Mean age at baseline was 79.94 ± 7.29 years, and 81.25% of patients were female. At baseline, mean BCVA was 70.44 ± 12.48 Early Treatment Diabetic Retinopathy Study (ETDRS) letters, mean CST was 339.8 ± 174.6.0 μm, and mean Maximal PED height was 214.3 ± 115.1 μm. After loading and at month 6, BCVA significantly increased by 2.47 and 3.41 ETDRS letters, respectively. Mean CST and PED height significantly decreased to 231.9 ± 68.69 μm and 137.6 ± 68.53 μm, respectively, at month 6. Qualitative and AI-quantified biomarkers significantly decreased after loading and at month 6. A mean interval of 9.67 ± 3.87 weeks was reached with a mean number of 4.63 ± 1.01 injections at the time of the last observation. Baseline IRF and HRF were negative predictors of functional outcomes in the short term. One patient with sterile vitritis benefited from vitrectomy and topical treatment.

Conclusions: Aflibercept intravitreal injections in the treatment of naïve patients with wet AMD demonstrated rapid improvement of functional and anatomical parameters, particularly regarding fluid control and quantitative biomarkers on OCT. A comprehensive analysis of follow-up visits will be performed to confirm our early results.

Introduction: To evaluate and characterize adverse events (AEs) associated with EVO and EVO+ implantable collamer lens (ICL) using real-world post-marketing surveillance data from the Food and Drug Administration (FDA)'s MAUDE database.

Methods: A retrospective analysis was conducted on AE reports related to EVO and EVO+ ICLs, including both spherical and toric models, submitted between 2015 and 2023. After excluding duplicate entries and incomplete records, reports were stratified by lens model and optical type into four groups: spherical EVO, toric EVO, spherical EVO+, and toric EVO+. Each report was independently reviewed by two senior ophthalmologists to classify the associated complications. Descriptive statistics were used to evaluate the proportional distribution of complications across subgroups and to assess the annual trend in reported AEs.

Results: A total of 17,482 AEs reports were analyzed. Across all subgroups, over half of the reports documented no clinical signs or symptoms. Blurred vision was the most frequently reported visual complaint, with a relatively higher reporting frequency in the EVO+ groups. Events involving elevated intraocular pressure and glaucoma were more commonly reported among EVO+ recipients. In addition, a number of rare but clinically significant complications were documented, including hemorrhage, hyphema, decreased intraocular pressure, endophthalmitis, and toxic anterior segment syndrome. The annual number of reported AEs showed a consistent upward trend throughout the study period.

Conclusion: This real-world data analysis provides insights into the distribution of major complications associated with ICL implantation in clinical practice. Comprehensive identification and reporting of rare adverse outcomes may help surgeons broaden their perspectives, enhance surgical preparedness, and provide more personalized and informed preoperative counseling.

Postoperative endophthalmitis (POE) is a rare but severe intraocular infection that can lead to irreversible vision loss if not promptly and adequately treated. This condition occurs when infecting organisms enter the eye through direct inoculation, such as during intraocular surgery, penetrating trauma, or contiguous spread from adjacent tissues. The risk of infection has also increased with the growing use of intravitreal pharmacotherapy, such as treatments with antivascular endothelial growth factor agents. Sources of infection in POE include bacteria colonized on the patient's eyelid margin and conjunctiva, healthcare personnel, surgical instruments, solutions, and intraocular lenses. Microbial trends indicate that Staphylococcus epidermidis (S. epidermidis) and unspecified coagulase-negative Staphylococci (CoNS) are the most prevalent pathogens. Fungal endophthalmitis, commonly caused by Candida albicans, primarily affects patients who are immunocompromised, including those with human immunodeficiency virus (HIV), malignancies, diabetes mellitus, immunosuppressive medication or intravenous drug use, solid organ transplantation, lung disease, and renal insufficiency. The management of POE relies on the prompt initiation of appropriate empirical antibiotic therapy targeting the most common causative organisms. However, antimicrobial resistance (AMR) has become one of the most pressing global health challenges, with the World Health Organization (WHO) recognizing AMR as one of the top ten global public health threats. The goal is to ensure the judicious use of antibiotics while preventing AMR development. A critical preventive strategy in ophthalmology is the use of antiseptics before interventional eye procedures. Studies have shown that the application of effective antiseptic agents-such as povidone-iodine (PVP-I), chlorhexidine (CHX), hypochlorous acid (HOCl), polyhexamethylene biguanide (PHMB), and picloxydine dihydrochloride can significantly reduce the incidence of postoperative infections, thereby minimizing the risk of endophthalmitis. This article reviews the importance, effectiveness, and benefits of preoperative antiseptic use in ophthalmology, emphasizing their role in preventing infections without encouraging antibiotic resistance. In addition to their preventive role, it also examines the potential therapeutic applications of these same agents in the management of ocular infections.

Introduction: Cystinosis is a multisystemic disease manifesting in the eyes initially as asymptomatic corneal cystine crystals and later with photophobia and serious visual impairment. Systemic effects of cystinosis arise from multiple cellular dysfunctions, causing early presymptomatic effects and progressive complications. Corneal crystals are observed across all layers of the cornea from infancy, and crystal accumulation during childhood is rapid. Early treatment is imperative, but in Europe, at the time of this study, no topical therapy was licensed for patients < 2 years of age.

Methods: This study was a paediatric investigation plan approved by the European Medicines Agency to assess the safety profile and efficacy of Cystadrops^® (cysteamine hydrochloride 0.55%) over a 90-day period in patients aged 6 to < 24 months. Five patients were monitored for adverse events throughout the study. Corneal crystal score, photophobia, and best corrected visual acuity were assessed in each patient at day 1 and day 90, where possible. Compliance to Cystadrops^® treatment was recorded.

Results: All primary endpoints were met. Any adverse events were mild and did not prevent treatment continuation. Corneal cystine crystal and photophobia scores declined or remained constant in all patients at a stage in life when an increase might be expected.

Conclusion: Although the rarity of the disease renders large studies on infants impracticable, there is no indication that the safety and efficacy profile of Cystadrops^® differs in patients above or below 2 years of age. The authors recommend treatment initiation as soon as corneal crystals are apparent.

Clinical trial registry: Clinical Trials No: 2018-002984-24.

Dry eye disease (DED) is highly prevalent among patients undergoing cataract surgery but is frequently underdiagnosed. Its presence can significantly affect preoperative biometric measurements and intraocular lens (IOL) power calculations, along with postoperative outcomes, particularly in patients receiving premium IOLs. Identifying and managing ocular surface disease (OSD) before surgery presents a valuable opportunity to optimize the ocular surface, reduce the risk of refractive surprises, and enhance both visual quality and patient satisfaction. This review summarizes current evidence on the prevalence of DED in patients with cataract, its impact on surgical planning and outcomes, and further outlines a practical approach for preoperative evaluation and optimization. Key strategies include risk stratification, targeted diagnostics, and individualized treatment regimens. Incorporating ocular surface assessment and treatment into the routine preoperative workflow is both feasible and essential in the context of modern cataract surgery. A structured, multimodal approach to DED management can significantly improve surgical precision and long-term visual outcomes.

Introduction: The aim of this study was to compare the estimated direct and indirect costs with aflibercept 8 mg and faricimab in patients with neovascular age-related macular degeneration (nAMD) or diabetic macular edema (DME) over 5 years.

Methods: An economic model was developed to estimate direct and indirect costs based on the mean number of injections administered in clinical trials of aflibercept 8 mg (PULSAR and PHOTON) and faricimab (TENAYA/LUCERNE and YOSEMITE/RHINE). Injection numbers for years 1 and 2 were sourced from clinical trials, injection numbers in years 3-5 were imputed from year 2, and the base case for the analysis was a 3-year time horizon. Direct costs were estimated based on modeled mean injection numbers and 2025 wholesale acquisition costs per injection (aflibercept 8 mg: 2677.50 USD; faricimab: 2289.65 USD) plus medical monitoring costs. Indirect costs included caregiver and patient time and travel costs.

Results: Over a 3-year time horizon, the mean number of injections was lower with aflibercept 8 mg versus faricimab for nAMD (12.25 vs. 14.80 injections) and DME (11.80 vs. 15.65 injections). Total costs (direct and indirect) associated with aflibercept 8 mg were 1978.74 USD lower than faricimab for nAMD and 6032.90 USD lower than faricimab for DME. After year 1, similar differences were seen through 5 years.

Conclusions: For both nAMD and DME, less frequent dosing with aflibercept 8 mg versus faricimab is expected to reduce the direct and indirect cost burden to payers and patients.

Introduction: A 24-week phase 3 analysis previously demonstrated equivalent efficacy and comparable tolerability between candidate biosimilar CT-P42 and reference aflibercept in participants with diabetic macular edema. Here, we report long-term outcomes through week 52.

Methods: This was a randomized, double-masked, active-controlled, phase 3 international trial, conducted at 83 study centers across Czech Republic, Estonia, Germany, Hungary, India, Latvia, Lithuania, Poland, Republic of Korea, Russia, Slovakia, Spain, and Ukraine. Adults (aged ≥ 18 years) diagnosed with type 1 or 2 diabetes mellitus, with diabetic macular edema involving the center of the macula, were randomized (1:1) to receive CT-P42 or reference aflibercept (2 mg in 0.05 mL) by intravitreal injection every 4 weeks (five doses), then every 8 weeks (four doses), over a 52-week study period. Study data were collected from July 2021 to April 2023. Efficacy, safety, and immunogenicity of CT-P42 compared with reference aflibercept were evaluated until week 52.

Results: Overall, 306 participants (CT-P42, 153; reference aflibercept, 153) completed the study through week 52. The primary efficacy endpoint of mean change from baseline in best corrected visual acuity through week 8 was reported previously. Improvements in best corrected visual acuity were maintained throughout and were similar between CT-P42 and reference aflibercept, with mean (standard deviation) change from baseline at week 52 of 12.1 (8.9) versus 11.1 (9.9) letters, respectively. Changes from baseline in central subfield thickness and other secondary efficacy endpoints as well as safety endpoints, including treatment-emergent adverse events and immunogenicity, were comparable between groups through week 52.

Conclusions: Results through week 52 support the therapeutic equivalence between CT-P42 and reference aflibercept by demonstrating comparable long-term efficacy, safety, and immunogenicity.

Trial registration: ClinicalTrials.gov identifier: NCT04739306.

Introduction: Vernal keratoconjunctivitis (VKC) is a chronic, recurrent ocular surface disease of childhood that often requires long-term anti-inflammatory therapy beyond topical corticosteroids. This study aimed to identify the clinical predictors of suboptimal treatment response with 0.1% cyclosporine A cationic emulsion (CsA CE) in a real-world pediatric cohort.

Methods: This was a retrospective, single-center study including patients aged 4-18 years with moderate or severe VKC, evaluated at a multidisciplinary ophthalmology clinic between January 2021 and December 2024. All patients received 0.1% CsA CE (administered four times daily). Demographic, clinical, and anamnestic data were collected. Disease severity was assessed using the Bonini grading scale, which provides a semiquantitative evaluation of ocular signs and symptoms. Statistical analysis was performed using univariate and multivariate Cox regression. For significant parameters, ROC curves were generated and optimal cut-off values were identified using the Youden's Index.

Results: A total of 101 patients were included (mean age 8.86 ± 3.31 years; 27 females). Over a mean follow-up period of 1.44 ± 1.13 years, 18 patients (17.8%) required escalation to 1% CsA galenic eye drops, of whom seven were further switched to 0.1% tacrolimus galenic eye drops. On multivariate analysis, the baseline composite clinical score was the strongest predictor of suboptimal treatment response. Notably, the clinical signs score alone demonstrated superior discriminative ability (AUC 0.732) compared to the total score (AUC 0.714). Optimal cut-off values were identified as 7 for clinical signs and 15 for the overall score.

Conclusions: Baseline disease severity, particularly the score for clinical signs, is a reliable predictor of response to 0.1% CsA CE. In patients exceeding the identified thresholds, early therapeutic escalation may be warranted to improve disease control and prevent structural complications.

Introduction: A newly developed diffractive continuous range of vision (CRV) intraocular lens (IOL) (TECNIS Odyssey) was introduced to reduce photic phenomena compared to the previous model (Synergy). This brief report is the first to evaluate the early postoperative outcomes of the new CRV IOL in a Japanese population.

Methods: This retrospective review included 50 eyes of 25 patients with cataracts who underwent bilateral implantation of modified CRV IOLs (models DNR00V and DRT150-375, TECNIS Odyssey). Clinical records of the patients were obtained. One month postoperative assessments included monocular and binocular uncorrected visual acuity (UCVA) and distance-corrected visual acuity (DCVA) at 5 m, 60 cm, and 40 cm. Additionally, binocular photopic contrast sensitivity, defocus curve, spectacle independence, incidence of photic phenomena, and overall patient satisfaction were evaluated.

Results: The mean patient age was 65.2 ± 8.4 years, with a mean IOL power of 17.4 ± 4.7 D. Postoperative binocular UCVA/DCVA (logMAR) at 5 m, 60 cm, and 40 cm was - 0.18 ± 0.06/ - 0.21 ± 0.06, - 0.01 ± 0.08/ - 0.01 ± 0.08, and 0.00 ± 0.08/0.00 ± 0.07, respectively. Contrast sensitivity remained within normal limits at all spatial frequencies. The binocular defocus curve showed DCVA of 0.0 logMAR or better across a range from + 0.5 to - 2.0 D. Spectacle independence was achieved in 64% of patients, whereas the remainder required reading glasses. Reports of glare and starburst were minimal (84% and 76% of patients reported none or minimal, respectively), whereas 52% experienced moderate to severe halos. Overall, 96% of the patients were satisfied or very satisfied with their distance and intermediate vision, and 68% were satisfied with their near vision.

Conclusions: The new diffractive CRV IOL offers simultaneous vision across a broad range, with improved tolerance to photic phenomena, while maintaining comparable visual acuity at far, intermediate, and near distances compared to the previous model.