Ophthalmology and Therapy最新文献

Introduction: To compare the U.S. Food and Drug Administration (FDA) premarket approval (PMA) trials of topography-guided laser in situ keratomileusis (TG-LASIK) and ray tracing-guided LASIK (RT-LASIK) for the treatment of myopia and myopic astigmatism.

Methods: This comparative study was conducted between TG-LASIK (P020050/S012; Alcon Laboratories, Inc., Fort Worth, TX, USA) with Allegretto Wave Eye-Q laser and topography-guided custom ablation treatment planning software, and "WaveLight Plus" RT-LASIK (P020050/S043; Alcon Laboratories, Inc.) using the WaveLight EX500 excimer laser and InnovEyes Sightmap. Clinical outcomes were compared, including visual and refractive measures, astigmatic correction, mesopic contrast sensitivity, higher-order aberrations, and patient-reported outcomes.

Results: This analysis included 249 eyes (212 patients) that underwent TG-LASIK and 336 eyes (168 patients) that underwent RT-LASIK. At 12 months, uncorrected distance visual acuity of 20/16 or better (64.8% TG-LASIK vs. 70.2% RT-LASIK) and 20/20 or better (92.6% TG-LASIK vs. 94.4% RT-LASIK) did not differ statistically between platforms. However, more TG-LASIK eyes had 20/10 or better (15.7% vs. 2.5%, P < 0.001) and 20/12.5 or better (34.4% vs. 26.4%, P = 0.044) than RT-LASIK eyes. Both platforms demonstrated comparable refractive predictability and stability (P > 0.05). For preoperative cylinder between - 1.00 to - 4.00 D, RT-LASIK showed greater astigmatic overcorrection (P < 0.05). At 3 months, RT-LASIK showed higher mesopic contrast sensitivity at 3, 6, and 12 cycles per degree under glare, with more eyes achieving clinically significant gains compared to TG-LASIK (P < 0.001). Both platforms induced changes in total higher-order aberrations, although not clinically significant. RT-LASIK also reduced spherical aberration from baseline. Both procedures showed a reduction in symptom severity for glare, halos, starburst, double vision, and dry eye.

Conclusions: While TG-LASIK showed superior visual acuity outcomes, RT-LASIK was associated with higher contrast sensitivity; however, both platforms demonstrate excellent visual and refractive outcomes. The majority of published studies are consistent with FDA PMA trends, showing potential reductions in spherical aberration and higher rates of 20/20 or better visual acuity with RT-LASIK.

Introduction: Thyroid eye disease (TED) is a rare, autoimmune, orbital inflammatory disorder that is disfiguring, debilitating, and potentially sight-threatening. There is an unmet need for a fast-acting, durable, systemic disease-modifying therapy in active TED, for which current options are associated with relapses and side effects, and for chronic inactive TED, which is largely managed with surgery. Satralizumab is a recombinant humanized anti-interleukin-6 receptor (IL-6R) monoclonal antibody that prevents IL-6 from binding to its receptor, thereby reducing proinflammatory and profibrotic signaling. The SatraGO-1 and SatraGO-2 trials evaluated the efficacy, safety, pharmacokinetics, and pharmacodynamics of satralizumab in participants with active, moderate-to-severe, and chronic inactive TED.

Methods: SatraGO-1 and SatraGO-2 were two identically designed, 72-week, double-masked, placebo-controlled, multicenter, two-stage randomization, phase 3 trials in adults with active, moderate‑to‑severe TED or chronic inactive TED. Participants were randomized 1:1 to receive satralizumab or matching placebo. Based on the proptosis response assessed at week 24, nonresponders received satralizumab every 4 weeks (Q4W), while responders were rerandomized in a 1:1 ratio to receive satralizumab or placebo Q4W through week 44. The primary end point was the proportion of participants with active, moderate-to-severe TED who achieved ≥ 2-mm reduction in proptosis in the study eye from baseline at week 24.

Results: SatraGO-1 and SatraGO-2 enrolled 131 and 127 participants, respectively.

Conclusions: The SatraGO-1 and SatraGO-2 trials investigated IL-6R inhibition via satralizumab in TED. Satralizumab offers a potential disease-modifying treatment option for TED while minimizing safety risks associated with current treatments.

Trial registration: SatraGO-1 (NCT05987423) and SatraGO-2 (NCT06106828).

Introduction: Short-term side effects often hinder the adoption of low-dose atropine in myopia management. Evidence from long-term observations and guidance on optimal dosing frequency is needed to inform clinical practice. This study aims to evaluate the effects of 0.05% atropine on near-work-related effects, accommodation, and binocular vision over 1 year of treatment.

Methods: Chinese children with myopia (aged from 6 to 14 years, cycloplegic spherical equivalent ≤ -1.00 D in both eyes) were enrolled between March 2021 and August 2023 at Changsha Aier Eye Hospital. Participants were randomly assigned to three regimen groups of 0.05% atropine: once daily (Qd), twice per week (Tw), and once per week (Qw) groups. Reported visual quality related side effects, the change of near work parameters, including visual acuity, reading distance, accommodation and binocular vision under the use of 0.05% atropine during 12 months were the main study outcomes.

Results: A total of 205 children were included in the study, 76 in Qd group, 70 in Tw group, and 59 in Qw group. Self-reported side-effects remained low in all groups, but showed frequency dependence. No cases of strabismus were reported or diagnosed. The most complaint side-effect was photophobia and blur at near (7.9% and 7.9%) at week 2 in Qd group, and both dropped to 3.9% at month 12. Pupil size under both photopic and mosopic, and viewing distance when reading consistently enlarged compared with baseline. All groups showed short-term changes in accommodation, and binocular vision, but gradually returned to baseline level by month 12. Mean (SE) of accommodation convergence to accommodation ratio (AC/A) in Qd group was 5.13(0.15), 5.82(0.16), 5.33(0.17), 5.22(0.17) Δ/D at baseline, week 2, month 6, and month 12, respectively; 5.09(0.16), 5.48(0.19), 5.42(0.19), 5.22(0.16) Δ/D in Tw group; and 4.90(0.19), 5.32(0.20), 5.17(0.19), 5.17(0.18) Δ/D in Qw group.

Conclusions: Long-term use of 0.05% atropine appears to be safe in children with myopia. Although short-term visual function changes and side effects were associated with higher dosing frequency, these effects were largely transient and resolved over time.

Introduction: Accurate ophthalmic imaging reports, including fundus fluorescein angiography (FFA) and ocular B-scan ultrasound, are essential for effective clinical decision-making. The current process, involving drafting by residents followed by review by ophthalmic technicians and ophthalmologists, is time-consuming and prone to errors. This study evaluates the effectiveness of ChatGPT-4o in auditing errors in FFA and ocular B-scan reports and assesses its potential to reduce time and costs within the reporting workflow.

Methods: Preliminary 100 FFA and 80 ocular B-scan reports drafted by residents were analyzed using GPT-4o to identify the errors in identifying left or right eye and incorrect anatomical descriptions. The accuracy of GPT-4o was compared to retinal specialists, general ophthalmologists, and ophthalmic technicians. Additionally, a cost-effective analysis was conducted to estimate time and cost savings from integrating GPT-4o into the reporting process. A pilot real-world validation with 20 erroneous reports was also performed between GPT-4o and human reviewers.

Results: GPT-4o demonstrated a detection rate of 79.0% (158 of 200; 95% CI 73.0-85.0) across all examinations, which was comparable to the average detection performance of general ophthalmologists (78.0% [155 of 200; 95% CI 72.0-83.0]; P ≥ 0.09). Integration of GPT-4o reduced the average report review time by 86%, completing 180 ophthalmic reports in approximately 0.27 h compared to 2.17-3.19 h by human ophthalmologists. Additionally, compared to human reviewers, GPT-4o lowered the cost from $0.21 to $0.03 per report (savings of $0.18). In the real-world evaluation, GPT-4o detected 18 of 20 errors with no false positives, compared to 95-100% by human reviewers.

Conclusions: GPT-4o effectively enhances the accuracy of ophthalmic imaging reports by identifying and correcting common errors. Its implementation can potentially alleviate the workload of ophthalmologists, streamline the reporting process, and reduce associated costs, thereby improving overall clinical workflow and patient outcomes.

Introduction: To evaluate long-term outcomes of neovascular age-related macular degeneration(nAMD) treatment with aflibercept in a treat-and-extend (T&E) regimen and explore correlations between optical coherence tomography (OCT) biomarkers and clinical evolution over 5 years in a real-world setting.

Methods: This retrospective monocentric study included patients diagnosed with type 1 or type 2 nAMD at the University Magna Graecia of Catanzaro between 2016 and 2024. Inclusion criteria were treatment-naïve status, diagnosis confirmed by OCT and optical coherence tomography angiography (OCT-A), exclusive treatment with intravitreal aflibercept following a T&E regimen, and a minimum 5-year follow-up. Best-correct visual acuity (BCVA) and OCT were assessed at baseline, after the third injection, and yearly up to year 5 (seven time points). Evaluated OCT biomarkers included subretinal and intraretinal fluid (SRF, IRF), hyperreflective spots (HS), drusenoid pigment epithelial detachment (dPED), subretinal hyperreflective material (SHRM), outer retinal tubulations (ORT), onion sign, retinal pigment epithelium (RPE) tears, and subretinal fibrosis.

Results: Among 59 cases, 57.6% were type 1 macular neovascularization (MNV) and 42.4% type 2. At the baseline, SRF was more common in type 1, SHRM in type 2. Central foveal thickness (CFT) decreased significantly in both groups after loading and remained stable. SRF decreased significantly in type 1 (p = 0.001), but not in type 2. dPED decreased in both groups, significantly in type 1 (p = 0.01). HS decreased in patients with type 1 MNV (p = 0.009). RPE tears were more frequent in type 2 (12%) and linked to BCVA loss. For type 2 MNV, ORT (p = 0.035) and subretinal fibrosis appeared from year 5 (p = 0.006). BCVA improved after loading in both groups, declined after year 2, and was better preserved in those with better visual acuity after the loading dose.

Conclusions: Baseline SHRM in type 2 MNV may predict more IRF, ORT, and RPE tears over time. Type 1 MNV with baseline SRF often shows reduced HS and dPED but may develop subretinal fibrosis. BCVA gains after loading wane by year 5, and eyes needing ongoing treatment for persistent OCT biomarkers decline gradually in both subtypes (significant in type 1).

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.