Daniel Ezra, Atif Collins, Zdenka Haskova, Thomas Kuenzel, Hiroaki Ida, Miriam Triyatni, Christopher Brittain, Oluwatobi Idowu
{"title":"Targeting IL-6 Receptor Signaling with Satralizumab in Thyroid Eye Disease: Design of the Phase 3 SatraGO-1 and SatraGO-2 Trials.","authors":"Daniel Ezra, Atif Collins, Zdenka Haskova, Thomas Kuenzel, Hiroaki Ida, Miriam Triyatni, Christopher Brittain, Oluwatobi Idowu","doi":"10.1007/s40123-025-01255-3","DOIUrl":"https://doi.org/10.1007/s40123-025-01255-3","url":null,"abstract":"<p><strong>Introduction: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>SatraGO-1 and SatraGO-2 enrolled 131 and 127 participants, respectively.</p><p><strong>Conclusions: </strong>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.</p><p><strong>Trial registration: </strong>SatraGO-1 (NCT05987423) and SatraGO-2 (NCT06106828).</p>","PeriodicalId":19623,"journal":{"name":"Ophthalmology and Therapy","volume":" ","pages":""},"PeriodicalIF":3.2,"publicationDate":"2025-10-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145251928","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Samy El Omda, Nikolaos Tzoumas, Margarita Calonge, Francisco Figueiredo
{"title":"International Survey of Current Approaches to the Management of Neuropathic Corneal Pain by Experts.","authors":"Samy El Omda, Nikolaos Tzoumas, Margarita Calonge, Francisco Figueiredo","doi":"10.1007/s40123-025-01242-8","DOIUrl":"https://doi.org/10.1007/s40123-025-01242-8","url":null,"abstract":"<p><strong>Introduction: </strong>Neuropathic corneal pain (NCP) is a challenging condition with limited consensus on its diagnosis and management. This study aimed to gather global insights from corneal specialists on the causes, investigative approaches, and management strategies for NCP.</p><p><strong>Methods: </strong>A 32-question survey covering demographic, causes, investigations, treatments, and multidisciplinary engagement was sent to 152 invited international corneal specialists; 51 (34%) responded. We explored descriptive statistics and examined how responder characteristics influenced their answers.</p><p><strong>Results: </strong>The most reported causes of NCP were chronic ocular surface disease (n = 41; 41%) and post-surgical factors (n = 34; 34%). The most common investigations, routinely performed by respondents, were the anesthetic challenge test, Schirmer's test, and corneal esthesiometry. In vivo confocal microscopy (IVCM) was routinely used by 37% (n = 19), with 69% (n = 29) of specialists stating that an abnormal result influenced their management. Ocular surface and pain questionnaires were used by 69% (n = 35), with the Ocular Surface Disease Index being the most popular (n = 25; 31%). Common treatments included artificial tears (n = 48; 94%), serum/plasma-derived tears (n = 41; 80%), topical corticosteroids (n = 34; 67%), and topical cyclosporin (n = 30; 59%). Only 38% (n = 19) felt comfortable independently prescribing systemic pharmacotherapy. A multidisciplinary approach was adopted by 47% (n = 24), with the two most common specialties involved being pain management (n = 30; 37%) and neurology (n = 26, 32%).</p><p><strong>Conclusions: </strong>This survey provides valuable global insights into the causes, investigations, and management of NCP from the perspective of corneal specialists. These findings support further research and the development of guidelines to address this challenging condition.</p>","PeriodicalId":19623,"journal":{"name":"Ophthalmology and Therapy","volume":" ","pages":""},"PeriodicalIF":3.2,"publicationDate":"2025-10-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145251973","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Suxia Li, Jianjiang Xu, Jin Yuan, Zhiqiang Pan, Giacomo Siri, Scott G Hauswirth, Flavio Mantelli, Weiyun Shi
{"title":"Cenegermin for the Treatment of Moderate or Severe Neurotrophic Keratopathy: Results from a Prospective, Phase IV, Open-Label Study in China.","authors":"Suxia Li, Jianjiang Xu, Jin Yuan, Zhiqiang Pan, Giacomo Siri, Scott G Hauswirth, Flavio Mantelli, Weiyun Shi","doi":"10.1007/s40123-025-01253-5","DOIUrl":"https://doi.org/10.1007/s40123-025-01253-5","url":null,"abstract":"<p><strong>Introduction: </strong>Neurotrophic keratopathy (NK) is a rare degenerative disease that can lead to epithelial breakdown, corneal ulceration, and potentially perforation and vision loss. Cenegermin is a recombinant human nerve growth factor approved for stage 2/3 NK, though data on its efficacy outside of United States/European populations are limited.</p><p><strong>Methods: </strong>This prospective, phase IV, open-label, multicenter study investigated the efficacy, safety, and pharmacokinetics (PK) of cenegermin eye drops in Chinese patients with stage 2/3 NK in a routine clinical setting (CTR20220066). Patients received cenegermin eye drops (20 mcg/mL; 6 times/day at 2-hour intervals) for 8 weeks with follow-up to week 56. The primary endpoint was corneal healing at week 8 per investigator assessment. Additional endpoints included lesion worsening, corneal healing through week 56, safety, and PK.</p><p><strong>Results: </strong>Of the 28 patients receiving cenegermin, 22/26 (84.6%, 95% confidence interval 65.1-95.6%; 2 missing) achieved corneal healing at week 8; 3/22 (13.6%) reported recurrence during 48-week follow-up but 20/22 (90.9%) were healed at week 56; and 2/28 (7.1%) experienced lesion worsening during 8-week treatment. In addition, 25/28 (89.3%) experienced ≥ 1 treatment-emergent adverse event (TEAE); for the majority (23/28, 82.2%) of these patients, TEAEs were mild/moderate. None of the serious TEAEs reported by 10 (35.7%) patients were assessed as related to cenegermin or led to treatment discontinuation. Eye pain was the most common cenegermin-related TEAE (5/28, 17.9%), primarily limited to the treatment period.</p><p><strong>Conclusions: </strong>These findings demonstrate that cenegermin eye drops are an effective, generally well-tolerated treatment in Chinese patients with stage 2/3 NK, supporting their use in this patient population.</p><p><strong>Trial registration: </strong>CTR20220066.</p>","PeriodicalId":19623,"journal":{"name":"Ophthalmology and Therapy","volume":" ","pages":""},"PeriodicalIF":3.2,"publicationDate":"2025-10-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145228393","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Inder Paul Singh, George R Reiss, Brian E Flowers, L Jay Katz, Dale W Usner, David Applegate, Angela C Kothe, Tomas Navratil
{"title":"Administration of the Travoprost Intracameral Implant in an Office-Based Surgery Setting.","authors":"Inder Paul Singh, George R Reiss, Brian E Flowers, L Jay Katz, Dale W Usner, David Applegate, Angela C Kothe, Tomas Navratil","doi":"10.1007/s40123-025-01254-4","DOIUrl":"https://doi.org/10.1007/s40123-025-01254-4","url":null,"abstract":"<p><strong>Introduction: </strong>The purpose of this analysis was to assess the safety outcomes of a subgroup of patients who received a travoprost intracameral implant in an office-based surgery setting from one of the phase 3 registration trials, GC-012, for the implant.</p><p><strong>Methods: </strong>Adult patients with open-angle glaucoma or ocular hypertension on 0 to 3 pre-study intraocular pressure (IOP)-lowering medications underwent a washout period (if applicable). Patients who qualified based on having an unmedicated mean diurnal IOP of 21 mmHg or greater and an IOP of 36 mmHg or less at each of the diurnal timepoints received a travoprost intracameral implant and were followed for safety outcomes at eight visits over a 12-month period. Safety evaluations included adverse events, slit-lamp examination, gonioscopy, pachymetry, dilated fundus examination, specular microscopy, perimetry, and best-corrected visual acuity.</p><p><strong>Results: </strong>A total of 37 patients received a travoprost intracameral implant in an office-based surgery setting. Administration of the implant was successful in 100% of patients. There were no serious ocular adverse events or ocular infections in patients administered the implant.</p><p><strong>Conclusions: </strong>This subgroup analysis demonstrated that administration of the travoprost intracameral implant in an office-based surgery setting was safe and well tolerated.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov identifier, NCT03868124.</p>","PeriodicalId":19623,"journal":{"name":"Ophthalmology and Therapy","volume":" ","pages":""},"PeriodicalIF":3.2,"publicationDate":"2025-10-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145228424","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Restoring Vision with Noninvasive Brain Stimulation: A Narrative Review.","authors":"Xinyan Duan, Yulian Zhou, Peng Zhang, Wen Wen, Chen Zhao","doi":"10.1007/s40123-025-01249-1","DOIUrl":"https://doi.org/10.1007/s40123-025-01249-1","url":null,"abstract":"<p><p>Vision impairment resulting from defects in the visual pathway was once considered irreversible. The main barrier is the limited plasticity of the visual system after the critical period. However, as our understanding of noninvasive brain stimulation (NIBS) deepens, its ability to enhance neural plasticity and regulate the neural system indicates a transformation in treatment and rehabilitation strategies. To verify the potential of NIBS in visual restoration, this review elaborates on the mechanisms underlying the immediate effects and aftereffects of NIBS with proofs from molecular, cellular, and systematic levels. The concept of neural oscillation is especially emphasized as it contributes greatly to cognition and can be interfered with by NIBS. Meanwhile, it discusses recent clinical findings on the use of NIBS, with or without visual perceptual learning, focusing on two key questions which have not been specified in previous reviews: (1) the duration of behavioral improvements, and (2) the optimal treatment period required for different visual functions and NIBS modalities. On the basis of the inconsistency in existing studies, this review is also devoted to optimizing the practical application of combining NIBS with VPL and concludes that the location, timing, and form of NIBS are crucial to achieving satisfying complementary effects.</p>","PeriodicalId":19623,"journal":{"name":"Ophthalmology and Therapy","volume":" ","pages":""},"PeriodicalIF":3.2,"publicationDate":"2025-10-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145207283","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Junmeng Li, Bei Rong, Lei Zhu, Ruilin Zhu, Xin Rong, Yuwei Wang, Yadi Zhang, Xiaopeng Gu, Shuang Zeng, Yanye Lu, Liu Yang
{"title":"One-Month Changes in Choroidal Vascularity Index of Medium Vessel Layer in Children with Myopia Wearing Orthokeratology Lenses: a Predictor for One-Year Changes in Axial Length.","authors":"Junmeng Li, Bei Rong, Lei Zhu, Ruilin Zhu, Xin Rong, Yuwei Wang, Yadi Zhang, Xiaopeng Gu, Shuang Zeng, Yanye Lu, Liu Yang","doi":"10.1007/s40123-025-01210-2","DOIUrl":"10.1007/s40123-025-01210-2","url":null,"abstract":"<p><strong>Introduction: </strong>Orthokeratology (ortho-K) is an established intervention for myopia control in children, yet the vascular mechanisms within the choroidal sublayers underlying its efficacy remain unclear. This study aims to investigate the changes in the choroidal vascularity index (CVI) of choroid sublayers after ortho-K treatment, the association between 1-month CVI changes and 1-year axial length (AL) elongation, and the role of CVI responses in predicting the 1-year control efficacy of ortho-K treatment.</p><p><strong>Methods: </strong>A prospective cohort study was conducted, enrolling 257 children with myopia aged 7-16 years. The subjects wore ortho-K lenses continuously for 12 months. Choroidal volume, vascular volume (CVV), stromal volume (CSV), and CVI of the choroid sublayers were assessed using optical coherence tomography images at baseline and 1-month follow-up. The total choroidal layer (TCL) includes the large-vessel choroidal layer (LVCL) and the medium-vessel choroidal layer (MVCL). The Early Treatment of Diabetic Retinopathy Study (ETDRS) grid divides the macular area into nine subfields for detailed analysis.</p><p><strong>Results: </strong>The 1-month CVI of TCL and MVCL in all ETDRS grid regions were significantly lower than the baseline CVI (P ≤ 0.036), except for the superior outer ring subfield in TCL (P = 0.070). After the 1-month ortho-K treatment, both choroidal volume and CSV significantly increased in all choroidal sublayers compared with baseline data (P ≤ 0.027), while CVV also showed significant increases in half of the ETDRS grid regions (14/27). After adjusting for age and gender, the baseline CVI of temporal inner ring subfield in TCL (β = 0.146, P = 0.006), and 1-month CVI changes of the temporal outer ring subfield (β = 0.337, P < 0.001) and nasal inner ring subfield (β = 0.174, P = 0.002) in MVCL, were independently associated with 1-year AL elongation during ortho-K treatment. On the basis of the 1-month CVI changes of temporal outer ring subfield and nasal inner ring subfield in MVCL, as well as age and sex, the prediction model demonstrated an area under the curve (AUC) of 0.905 (95% CI 0.870-0.941) for distinguishing children with myopia who exhibited slow versus fast AL elongation.</p><p><strong>Conclusions: </strong>After the 1-month ortho-K treatment, choroidal volume, CVV, and CSV, of all choroidal sublayers significantly increased, while CVI of TCL and MVCL significantly decreased. The CVI in LVCL showed no significant changes. The differences in short-term CVI changes among choroidal sublayers indicate disproportionate changes in CVV and CSV, which help to explore the possible choroidal mechanisms of myopia control with ortho-K treatment. Early CVI changes in MVCL possess potential clinical significance for predicting long-term AL elongation.</p>","PeriodicalId":19623,"journal":{"name":"Ophthalmology and Therapy","volume":" ","pages":"2395-2413"},"PeriodicalIF":3.2,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12413386/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144743509","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Postoperative Rotation and Refractive Efficacy of Toric Intraocular Lenses After Phacoemulsification Cataract Surgery.","authors":"Vijay Shetty, Nitin Deshpande, Prajakta Deshpande, Jekin Choubisa, Akshay Chavan, Alfin Shaji, Seeba John, Amruta Pradhan, Maninder Singh Setia","doi":"10.1007/s40123-025-01207-x","DOIUrl":"10.1007/s40123-025-01207-x","url":null,"abstract":"<p><strong>Introduction: </strong>We evaluated the rotational stability and factors associated with it in patients implanted with Eyecryl™ roric IOL after phacoemulsification surgery. We also assessed the factors associated with refractive efficacy in these patients.</p><p><strong>Methods: </strong>The present study is a secondary analysis to study the rotation in 121 eyes from 94 patients. We included the following data: demographics; preoperative refraction and corrected distance visual acuity (CDVA), type of astigmatism, axial length, anterior chamber depth, and aqueous depth; power of the implanted IOL, axis of the implanted IOL, and predicted residual error; magnitude and direction of postoperative rotation of the IOL; postoperative vision and refraction (day 30 ± 3 days).</p><p><strong>Results: </strong>About 86% of the eyes had postoperative astigmatism of ≤ 0.25 D and 9% had 0.26 to 0.50 D on day 30. The median (IQR) rotation of the IOL on day 30 (± 3 days) was 1 (1, 3) degree and the mean (SD) rotation was 2.31 (2.97) degrees. Eyes with high rotation had significantly higher median (IQR) preoperative sphere (more positive side) (1.50 D [0, 1.75] vs 0 D [- 1.0, 0.75]; p = 0.013) and lower mean (SD) axial length (22.6 [0.9] vs 23.2 [0.9]; p = 0.02). The mean (SD) postoperative refractive efficacy was 85.1 (13.6) %; it was significantly lower in those who had with-the-rule astigmatism compared with against-the-rule astigmatism (69.6% vs 86.7%; p = 0.046). The proportion of eyes with difference in lines between postoperative UDVA and CDVA was significantly higher in those with low postoperative efficacy (70.0% vs 21.8%; p < 0.001).</p><p><strong>Conclusion: </strong>The Eyecryl™ toric intraocular lens had low rotation at 1-month post-surgery. Higher rotation was associated with a higher preoperative sphere (more positive side) and shorter eyes. Postoperative efficacy was higher in eyes with against-the-rule astigmatism. Eyes with < 75% efficacy and/or ≥ 5° rotation showed over-correction on vector analysis.</p>","PeriodicalId":19623,"journal":{"name":"Ophthalmology and Therapy","volume":" ","pages":"2415-2432"},"PeriodicalIF":3.2,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12413359/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144753959","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Yang Meng, Yuan Liu, Yuan Ma, Ziye Chen, Runping Duan, Lan Jiang, Tao Li
{"title":"Global, Regional, and National Burden of Blindness due to Diabetic Retinopathy, 1990-2021.","authors":"Yang Meng, Yuan Liu, Yuan Ma, Ziye Chen, Runping Duan, Lan Jiang, Tao Li","doi":"10.1007/s40123-025-01230-y","DOIUrl":"10.1007/s40123-025-01230-y","url":null,"abstract":"<p><strong>Introduction: </strong>This study aimed to analyze the patterns and trends in the burden of blindness due to diabetic retinopathy (DR) from 1990 to 2021 at the global, regional, and national levels.</p><p><strong>Methods: </strong>We conducted a population-based analysis using the latest data from the Global Burden of Disease Study 2021. We examined the prevalence and number of cases of DR-related blindness stratified by type of diabetes, sex, age, and sociodemographic index (SDI) level. The trends in the blindness burden were quantified via the average annual percentage changes. A decomposition analysis was performed to identify key drivers of the changing burden. A Bayesian age‒period‒cohort model was used to predict the future burden of DR-related blindness from 2022 to 2035.</p><p><strong>Results: </strong>Globally, the number of people blind due to DR increased by 326.0% from 1990 to 2021, with the age-standardized prevalence rate (ASPR) increasing from 7.59 to 15.28 per 100,000 population. Regionally, Tropical Latin America had the highest ASPR in 2021, whereas South Asia and East Asia had the greatest number of prevalent cases. Nationally, India and China had the highest number of prevalent cases in 2021, whereas Marshall Islands reported the highest ASPR. In 2021, the middle SDI group had the greatest number of patients who became blind due to DR. Decomposition analysis revealed that the increased global burden between 1990 and 2021 was driven by population growth, population aging, and epidemiological changes. Predictions suggest the burden will continue to rise through 2035.</p><p><strong>Conclusions: </strong>The global burden of DR-related blindness has increased significantly over the past three decades, with notable disparities across regions, countries, and SDI groups. More efforts should be made to mitigate the growing impact of DR-related blindness.</p>","PeriodicalId":19623,"journal":{"name":"Ophthalmology and Therapy","volume":" ","pages":"2599-2615"},"PeriodicalIF":3.2,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12413353/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144963815","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Efficacy and Safety of 0.01% Atropine Eye Drops and Novel Lenslet-ARray-Integrated Spectacle Lenses for the Prevention of Myopia Progression Among Children with Premyopia: A Randomized Clinical Trial.","authors":"Mingjun Gao, Yanhua Hou, Yutong Lu, Zhanhua Shi, Qi Zhao","doi":"10.1007/s40123-025-01214-y","DOIUrl":"10.1007/s40123-025-01214-y","url":null,"abstract":"<p><strong>Introduction: </strong>Previous studies have suggested that premyopia shows high prevalence and high risk of progression to myopia among children. Therefore, the purpose of this study was to investigate the efficacy and safety of 0.01% atropine eye drops and novel positive Lenslet-ARray-Integrated spectacle lenses (LARI) in slowing myopia onset and myopic shift among children with premyopia in China.</p><p><strong>Methods: </strong>This was a prospective randomized controlled trial. A total of 400 children aged 6-12 years with premyopia in both eyes were enrolled. Subjects were randomly divided into four groups in equal proportions: 0.01% atropine eye drops group (group A), LARI group (group S), combination group (group AS), and control group without any clinical intervention (group E). Measurements were conducted at baseline and at 3-, 6-, and 12-month follow-up. The incidence of myopia and the percentage of patients with fast myopic shift over 1 year were the primary outcomes. The secondary outcomes were changes in cycloplegic spherical equivalent refraction (SE) and axial length (AL). Changes in uncorrected visual acuity (UCVA), corneal curvature (CC), subfoveal choroidal thickness (SFCT), and intraocular pressure (IOP) were the exploratory outcomes. Adverse events were also recorded.</p><p><strong>Results: </strong>The incidence of myopia and the percentage of patients with fast myopic shift in groups A, S, and AS were significantly lower than those in group E. Treatment with 0.01% atropine, LARI, and their combination decreased myopia progression by 55.88%, 64.71%, and 77.94%, and axial elongation by 65.00%, 75.00%, and 77.50%, respectively. Further analyses were conducted based on age stratification. SFCT in intervention groups increased significantly. No serious adverse events were detected.</p><p><strong>Conclusions: </strong>These 1-year results suggest that, combined with the progression of SE, the reduction in AL, and the increase in SFCT, 0.01% atropine and LARI can be used as effective and safe treatments for the prevention of myopia progression in children with premyopia. Combination therapy showed superior efficacy in this cohort, but long-term effects beyond 12 months remain unknown.</p><p><strong>Trial registration: </strong>ChiCTR2500098887.</p>","PeriodicalId":19623,"journal":{"name":"Ophthalmology and Therapy","volume":" ","pages":"2481-2496"},"PeriodicalIF":3.2,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12413380/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144874439","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Chrysostomos Dimitriou, Panagiotis Dervenis, Jeremy C K Tan, Caroline Wong, Luke Tanner, Rynda Nitiahpapand, Ihsan Fazal, Georgios Chatzithanasis, Dimitrios Lolos, Dimitrios Stavropoulos, Nikolaos Dervenis, Gerassimos Lascaratos
{"title":"Real-World Data of the First UK Series of MINIject Supraciliary Glaucoma Implant with 6 Months Follow-Up.","authors":"Chrysostomos Dimitriou, Panagiotis Dervenis, Jeremy C K Tan, Caroline Wong, Luke Tanner, Rynda Nitiahpapand, Ihsan Fazal, Georgios Chatzithanasis, Dimitrios Lolos, Dimitrios Stavropoulos, Nikolaos Dervenis, Gerassimos Lascaratos","doi":"10.1007/s40123-025-01221-z","DOIUrl":"10.1007/s40123-025-01221-z","url":null,"abstract":"<p><strong>Introduction: </strong>This study evaluates the efficacy and safety of the MINIject (iStar Medical, Wavre, Belgium) supraciliary implant for the treatment of glaucoma.</p><p><strong>Methods: </strong>Patients with medically uncontrolled primary open angle glaucoma, primary angle closure glaucoma and normal tension glaucoma were included. This first in the UK, retrospective, single-centre, interventional study evaluated the implantation of the MINIject in 50 eyes, including 11 stand-alone cases and 39 cases combined with phacoemulsification. The primary outcome was mean reduction of intraocular pressure (IOP) at 6 months. We also report the proportion of eyes that achieved a final IOP ≤ 21 mmHg and > 5 mmHg with an IOP reduction of ≥ 20% with/without medication use.</p><p><strong>Results: </strong>Mean (± standard deviation) baseline IOP was 18.4 ± 4.7 mmHg on 2.1 ± 1.1 medications. There was a significant decrease in IOP at 6 months (-6.3; 95% confidence interval [CI] -2.9 to -9.7 mmHg, P < 0.001). There was no significant association between diagnosis, mode of delivery (stand-alone/combined with phacoemulsification) and the degree of IOP lowering. There was a significant decrease in IOP-lowering medications at 6 months (-2.1; 95% CI -1.6 to -2.6 mmHg, P < 0.001). A total of 88.9% of eyes achieved a final IOP ≤ 21 mmHg and > 5 mmHg, whilst 57.8% of eyes achieved this combined with 20% reduction in IOP. Adverse events occurred in 15.6% (n = 7) of eyes. No sight-threatening events occurred.</p><p><strong>Conclusions: </strong>This study shows promising IOP-lowering results and medication reduction over 6 months with few adverse events.</p>","PeriodicalId":19623,"journal":{"name":"Ophthalmology and Therapy","volume":" ","pages":"2433-2442"},"PeriodicalIF":3.2,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12413361/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144799759","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}