JAMA ophthalmology最新文献

{"title":"XXYLT1 and Mendelian Retinal Dystrophy.","authors":"Minna Kraatari-Tiri, Hina Ishtiaq, Jaakko Tyrmi, Siying Lin, Andriana Valkama, Timo Tiirikka, Sara Äikäs, Laura Lähteenoja, Genevieve Wright, Elena Schiff, Aleksandr Jestin, Andrew R Webster, Omar A Mahroo, Michel Michaelides, Jukka Moilanen, Katri Pylkäs, Johannes Kettunen, Gavin Arno, Aura Falck, Tuomo Mantere, Elisa Rahikkala","doi":"10.1001/jamaophthalmol.2026.2795","DOIUrl":"10.1001/jamaophthalmol.2026.2795","url":null,"abstract":"<p><strong>Importance: </strong>Substantial unexplained heritability remains for pathogenic inherited retinal disease (IRD) variants. Application of genome-wide association studies (GWAS) could help identify causal genes in rare diseases.</p><p><strong>Objective: </strong>To leverage a GWAS for the discovery of IRD-associated genes.</p><p><strong>Design, setting, and participants: </strong>This GWAS analysis was combined with replication of findings in 2 independent IRD cohorts. The study was conducted from January 2024 to December 2025 in a multicenter setting through FinnGen, 100 000 Genomes Project, and the National Health Service Genomic Medicine Service combined with clinical cohort from the Oulu University Hospital. Using IRD criteria from the International Classification of Diseases, 9th and 10th Revisions, 540 individuals with IRD and 473 945 control individuals were identified in the FinnGen study. For validation of FinnGen results, 49 patients were recruited from Oulu University Hospital. Results were further validated in 2 individuals identified from the UK cohort.</p><p><strong>Main outcomes and measures: </strong>The GWAS and proteomics analysis were performed in the FinnGen cohort. Sanger and whole-genome sequencing and RNA approaches were used in a clinical IRD cohort to validate pathogenicity of the identified XXYLT1 variant.</p><p><strong>Results: </strong>This GWAS identified 13 recessive loci reaching genome-wide significance (defined as P < 5 × 10-8). Of these, 4 (near or within XXYLT1, ANKRD10, DYM, and CBLN4) had not been associated with IRD, including the XXYLT1 c.505-1G>C founder variant. This variant was further genotyped in the clinical replication cohort, leading to identification of 5 more homozygous individuals from 4 families. The phenotype was consistent with a cone-rod or macular dystrophy, with visual deterioration, cystoid macular edema and/or schisislike macular abnormalities. The effect of the XXYLT1 c.505-1G>C variant was further investigated using RNA sequencing and complementary DNA amplicon sequencing, demonstrating exon 2 skipping and a loss-of-function effect. These findings were replicated in an independent population identifying 2 patients from the UK harboring a homozygous XXYLT1 c.766G>A, p.(Glu256Lys) missense variant.</p><p><strong>Conclusions and relevance: </strong>This GWAS identified an association between XXYLT1 and IRD. These results affirm that GWAS in a founder population can be used as a potential tool for the discovery of rare mendelian disease genes and that XXYLT1 should be considered in clinical IRD gene panels.</p>","PeriodicalId":14518,"journal":{"name":"JAMA ophthalmology","volume":" ","pages":"827-836"},"PeriodicalIF":10.5,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13425242/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148619980","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Standardization of Retinal Vasculitis Terminology With Consensus Definitions From a Delphi Panel.","authors":"James T Rosenbaum, Sapna Gangaputra, Marc D de Smet, Douglas A Jabs, James R Stone, Ilknur Tugal-Tutkun, Liang Yao, Vishali Gupta, Rupesh Agrawal","doi":"10.1001/jamaophthalmol.2026.2957","DOIUrl":"10.1001/jamaophthalmol.2026.2957","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Importance: &lt;/strong&gt;Retinal vasculitis is a sight-threatening condition associated with diverse ocular and systemic diseases. Variability in terminology and definitions across clinical practice and research has limited diagnostic consistency, communication among specialists, and comparability of studies.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;To develop standardized, consensus-based definitions for retinal vasculitis and related terms to improve diagnostic clarity and harmonize communication among ophthalmologists and other medical specialties.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Design, setting, and participants: &lt;/strong&gt;This was an international modified Delphi consensus study conducted using a structured consensus process guided by a comprehensive literature review, including systematic reviews and meta-analyses. Two rounds of Delphi surveys were performed, and consensus was predefined as at least 75% agreement. Included was an international expert panel of 27 specialists in ophthalmology, rheumatology, pathology, imaging, and research methodology. The specialists had recognized expertise in retinal and systemic vasculitis, retinal imaging, or consensus methodology. Study data were analyzed from March to September 2025.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Exposure: &lt;/strong&gt;Participation in a structured Delphi process evaluating proposed definitions and terminology related to retinal vasculitis and associated vascular inflammatory entities.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Main outcomes and measures: &lt;/strong&gt;Consensus definitions for retinal vasculitis and related entities, with agreement using predefined consensus thresholds.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;A total of 27 international experts participated in the Delphi process. After 5 executive committee members involved in developing preliminary definitions were excluded from voting to minimize bias, a total of 22 independent experts completed both Delphi rounds. All candidate statements exceeded the predefined consensus threshold in the first round (agreement range, 83.3%-95.5%), although some demonstrated variability in the strength of agreement. After refinement of definitions, consensus strengthened in the second round, with agreement levels ranging from 95.2% to 100%. The panel established consensus definitions for 8 terms: retinal vasculitis, vascular leakage, infectious retinal vasculitis, noninfectious retinal vasculitis, retinal perivasculitis, retinal vasculopathy, primary retinal vasculitis, and far-peripheral vascular leakage. These definitions were developed to distinguish vascular leakage from true vasculitis, clarify inflammatory and noninflammatory vascular disorders, and promote consistent terminology across clinical practice and research.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions and relevance: &lt;/strong&gt;This international Delphi consensus established standardized nomenclature for retinal vasculitis and related vascular inflammatory entities. Adoption of these definitions may improve diagnostic accuracy, facilitate interpretation of imaging f","PeriodicalId":14518,"journal":{"name":"JAMA ophthalmology","volume":" ","pages":"837-846"},"PeriodicalIF":10.5,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13448837/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148678546","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"High-Resolution Imaging of RPE Cellular Mosaic Over Drusen","authors":"Marco Lombardo, Raffaella Cascella, Andrea Cusumano","doi":"10.1001/jamaophthalmol.2026.3332","DOIUrl":"https://doi.org/10.1001/jamaophthalmol.2026.3332","url":null,"abstract":"This case report of a patient aged 37 years with asymptomatic bilateral drusen discusses how adaptive optics transscleral flood illumination imaging enabled in vivo has the potential to detect subtle retinal pigment epithelial (RPE) changes in patients with drusen.","PeriodicalId":14518,"journal":{"name":"JAMA ophthalmology","volume":"38 1","pages":""},"PeriodicalIF":8.1,"publicationDate":"2026-08-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148836185","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"An Unusual Microbial Coinfection in Acanthamoeba Keratitis","authors":"Irene J. Choi, Thuy Doan, Angela J. Verkade, Emily L. Vogt, Mercy Pawar, Maria A. Woodward","doi":"10.1001/jamaophthalmol.2026.3485","DOIUrl":"https://doi.org/10.1001/jamaophthalmol.2026.3485","url":null,"abstract":"This case report describes a severe, refractory case of acanthamoeba keratitis associated with intracellular coinfection by both <jats:italic toggle=\"yes\">Tokyovirus A1</jats:italic> and <jats:italic toggle=\"yes\">Candidatus Paracaedimonas acanthamoebae</jats:italic> in a 27-year-old male patient.","PeriodicalId":14518,"journal":{"name":"JAMA ophthalmology","volume":"17 1","pages":""},"PeriodicalIF":8.1,"publicationDate":"2026-08-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148836189","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"HOTV Vision Test Compared With Tumbling E for Pediatric Vision Screening","authors":"Haotian Wu, Yanjiao Wang, Zihan Ni, Yuhe Liu, Zhenglin Liu, Jun Chen, Haidong Zou, Ian G. Morgan, Xun Xu, Kathryn A. Rose, Xiangui He","doi":"10.1001/jamaophthalmol.2026.3425","DOIUrl":"https://doi.org/10.1001/jamaophthalmol.2026.3425","url":null,"abstract":"Importance Accurate assessment of uncorrected visual acuity (UCVA) is fundamental to pediatric vision screening. Although the HOTV letter-matching test is recommended for pediatric vision screening, the tumbling E test remains widely used globally despite its higher cognitive demands for young children. Evidence directly comparing UCVA outcomes between the 2 tests across pediatric age groups is limited. Objective To compare UCVA outcomes from HOTV and tumbling E vision tests and evaluate their suitability for pediatric vision screening. Design, Setting, and Participants In this cross-sectional observational study, each participant underwent UCVA testing with both HOTV and tumbling E logMAR charts in a randomized sequence, with a 30-minute rest period between tests to minimize fatigue. The study was conducted in Shanghai as part of a national multicenter cohort study in China. Participants included 995 children aged 3 to 15 years who completed both vision tests, cycloplegic refraction, and comprehensive ophthalmic examinations. These data were analyzed from January 2025 to June 2026. Exposure UCVA assessments using HOTV and tumbling E logMAR tests. Main Outcomes and Measures The primary outcome was mean UCVA (logMAR). Secondary outcomes included referral rates for reduced UCVA, screening performance for amblyopia and refractive errors, testability, and time required for vision test. Results Overall, mean (SD) UCVA was 0.15 (0.22) (20/25) with HOTV and 0.20 (0.20) (20/32) with tumbling E (95% CI, –0.07 to –0.02; <jats:italic>P</jats:italic> &amp;amp;lt; .001). The difference between the 2 tests decreased with age, initially 1 logMAR line in children aged 3 to younger than 4 years, more than 3 letters in those younger than 8 years, and reducing to 1 or less letters by age 8 years or older. Among 183 preschool children, HOTV test showed a lower referral rate (n = 34 [18.6%]) than tumbling E (n = 57 [31.2%]) (mean difference, −12.6%; 95% CI, −19.2% to −5.9%; <jats:italic>P</jats:italic> &amp;amp;lt; .001), along with a higher true positive rate (0.68 vs 0.44; <jats:italic>P </jats:italic> &amp;amp;lt; <jats:italic> </jats:italic> .001) and better specificity (0.93 vs 0.79 <jats:italic>; P </jats:italic> &amp;amp;lt; <jats:italic> </jats:italic> .001), with similar measures in older children. Conclusions and Relevance These findings support the use of the HOTV test for children younger than 8 years. Its use could reduce unnecessary referrals, especially in the context of growing global emphasis on pediatric vision screening and early detection of myopia. Trial Registration ClinicalTrials.gov Identifier: <jats:ext-link xmlns:xlink=\"http://www.w3.org/1999/xlink\" ext-link-type=\"uri\" xlink:href=\"https://clinicaltrials.gov/study/NCT05770661?term=NCT05770661&amp;amp;amp;viewType=Card&amp;amp;amp;rank=1\">NCT05770661</jats:ext-link>","PeriodicalId":14518,"journal":{"name":"JAMA ophthalmology","volume":"7 1","pages":""},"PeriodicalIF":8.1,"publicationDate":"2026-08-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148836184","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Digital Defocus Vision Training Using Virtual Reality for Myopia Control","authors":"Jing Zhong, Yu Liu, Tianli Peng, Jing Ma, Ziting Huang, Xiao Yang, Shi-Ming Li, Jin Yuan","doi":"10.1001/jamaophthalmol.2026.3490","DOIUrl":"https://doi.org/10.1001/jamaophthalmol.2026.3490","url":null,"abstract":"Importance Virtual reality–based digital defocus vision training (DDVT) may offer a home-based strategy to slow myopia progression in children, but evidence is limited. Objective To evaluate efficacy and safety of a head-mounted virtual reality–based DDVT system on myopia progression. Design, Setting, and Participants This randomized clinical trial was conducted among children aged 6 to 12 years with myopia enrolled in July 2024, with follow-up completed in September 2025. The trial was conducted at a single center in Guangzhou, China. Data were analyzed from September 2025 to October 2025. Intervention Participants were randomized to DDVT plus single-vision spectacles (SVS) or SVS alone. Participants in the DDVT group used a head-mounted virtual reality device at home for 15 minutes per day under parental supervision after an initial in-hospital training session. Main Outcomes and Measures The primary outcome was the between-group difference in axial length (AL) change from baseline to 6 months. The secondary outcome was between-group difference in spherical equivalent refraction (SER) change. Results Of 120 randomized participants, 57 of 60 participants in the DDVT group (95%) and 59 of 60 participants in the SVS group (98%) completed the study. At baseline, mean (SD) ages in the DDVT and SVS groups were 9.42 (1.52) years and 9.31 (1.13) years, respectively, and 53 of 116 participants (45.7%) were female. Mean (SD) AL and spherical equivalent in the DDVT and SVS groups were 24.35 (0.81) mm and 24.40 (0.81) mm and −1.91 (1.11) diopter (D) and −2.04 (1.06) D, respectively. Mean best-corrected visual acuity was −0.04 logMAR (Snellen equivalent, 20/18) and −0.03 logMAR (20/19), respectively. At 6 months, AL increased by 0.15 mm and 0.25 mm in the DDVT and SVS groups, respectively (difference = 0.11 mm; 95% CI, 0.07-0.15 mm; &lt;jats:italic&gt;P&lt;/jats:italic&gt; &amp;amp;lt; .001). SER changed by −0.23 D and −0.46 D (difference = −0.23 D; 95% CI, −0.35 to −0.11 D; &lt;jats:italic&gt;P&lt;/jats:italic&gt; = .003). Visual acuity change at 6 months was −0.02 logMAR (Snellen equivalent, 20/18) and 0.01 logMAR (20/20) in the DDVT and SVS groups, respectively (difference = 0.03 logMAR [Snellen equivalent, 20/21]; 95% CI, 0.02-0.05 [20/21-20/22]; &lt;jats:italic&gt;P&lt;/jats:italic&gt; &amp;amp;lt; .001). No training-related adverse events were observed. Conclusions and Relevance In this randomized clinical trial, the DDVT group had a small absolute reduction in AL and SER myopic progression compared with SVS alone over 6 months in 120 children with myopia aged 6 to 12 years. The clinical relevance of these differences over the short and long term cannot be determined from this trial but support additional studies to assess this intervention as a promising adjunctive approach for pediatric myopia control. Trial Registration ClinicalTrials.gov Identifier: &lt;jats:ext-link xmlns:xlink=\"http://www.w3.org/1999/xlink\" ext-link-type=\"uri\" xlink:href=\"https://clinicaltrials.gov/study/NCT07042022?","PeriodicalId":14518,"journal":{"name":"JAMA ophthalmology","volume":"189 1","pages":""},"PeriodicalIF":8.1,"publicationDate":"2026-08-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148836183","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Bilateral CRAO in a Healthy Young Adult After Cocaine Use","authors":"Paola Marolo, Enrico Borrelli, Michele Reibaldi","doi":"10.1001/jamaophthalmol.2026.3277","DOIUrl":"https://doi.org/10.1001/jamaophthalmol.2026.3277","url":null,"abstract":"This case report discusses bilateral central retinal artery occlusion (CRAO) in a young adult with no cardiovascular history who presented with bilateral vision loss 3 days after recreational cocaine use.","PeriodicalId":14518,"journal":{"name":"JAMA ophthalmology","volume":"186 1","pages":""},"PeriodicalIF":8.1,"publicationDate":"2026-08-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148768019","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Ultra–Long-Distance Robotic-Assisted Subretinal Injection for Submacular Hemorrhage","authors":"Andi Xu, Bo Yang, Bingqian Liu, Lin Lu, Zhangkai Lian, Wenben Chen, Rihui Song, Wang Guo, Subinuer Alimu, Zhenzhen Liu, Dong Liu, Yanlin Li, Wei Xiao, Mohammad Ali Nasseri, Kai Huang, Haotian Lin","doi":"10.1001/jamaophthalmol.2026.3303","DOIUrl":"https://doi.org/10.1001/jamaophthalmol.2026.3303","url":null,"abstract":"Importance Submacular hemorrhage (SMH) is a vision-threatening condition sometimes requiring timely intervention to try to reduce retinal damage. However, access to experienced vitreoretinal surgeons remains limited in many geographically remote regions, and further studies with controlled comparisons are needed to evaluate potential solutions. Objective To evaluate the feasibility and safety issues of ultra–long-distance robotic-assisted subretinal injection for the treatment of SMH. Design, Setting, and Participants This single-case report conducted between October 2025 and January 2026 at the following 2 centers separated by approximately 4000 km: Zhongshan Ophthalmic Center in Guangzhou, China (remote control center), and Xinjiang Production and Construction Corps Hospital in Urumqi, China (patient site). One patient with SMH was enrolled. Intervention Following pars plana vitrectomy performed manually, while the participant still was under general anesthesia, a retinal surgeon remotely teleoperated an ophthalmic robotic system to perform subretinal injection of recombinant tissue plasminogen activator. Main Outcomes and Measures Primary outcomes were procedural feasibility and safety, defined as successful completion of robotic subretinal injection without conversion to manual surgery and absence of intraoperative complications or serious postoperative adverse events. Secondary outcomes included hemorrhage resolution and best-corrected visual acuity during follow-up. Results The robotic-assisted procedure was successfully completed without intraoperative complications, with 7 minutes of robotic teleoperation during a total surgical time of 46 minutes. Mean (range) network latency was 77.9 milliseconds (71-90 milliseconds). A total of 0.056 mL of recombinant tissue plasminogen activator was delivered. No serious adverse events occurred during 3 months of follow-up. Optical coherence tomography demonstrated progressive hemorrhage reduction, with complete absorption by postoperative day 26. Preoperative best-corrected visual acuity measured 1 day before surgery was 0.6 logMAR (Snellen equivalent, 20/80) and remained stable at 0.6 logMAR (20/80) at 3 months postoperatively. Conclusions and Relevance In this single-case report, robotic-assisted intraocular microsurgery was feasible and safe across 4000 km. These findings provide proof-of-concept evidence that telesurgical robotic systems like this subretinal injection may expand access to specialized retinal procedures in geographically remote regions.","PeriodicalId":14518,"journal":{"name":"JAMA ophthalmology","volume":"73 1","pages":""},"PeriodicalIF":8.1,"publicationDate":"2026-08-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148768024","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Angioid Streaks in a 60-Year-Old Man","authors":"Dorian T’Sjoen, Julie De Zaeytijd, Olivier Vanakker","doi":"10.1001/jamaophthalmol.2026.3324","DOIUrl":"https://doi.org/10.1001/jamaophthalmol.2026.3324","url":null,"abstract":"A 60-year-old man presented with progressive vision loss over several weeks in his right eye, noting a dark spot in his central vision and metamorphopsia. What would you do next?","PeriodicalId":14518,"journal":{"name":"JAMA ophthalmology","volume":"6 1","pages":""},"PeriodicalIF":8.1,"publicationDate":"2026-08-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148768020","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Spectacle Lenses With Highly Aspherical Lenslets for Myopia Control","authors":"Jason Shen, Chris Hunt, Graeme Young, Björn Drobe","doi":"10.1001/jamaophthalmol.2026.3288","DOIUrl":"https://doi.org/10.1001/jamaophthalmol.2026.3288","url":null,"abstract":"Importance Myopia prevalence is rising in the US. Spectacle lenses with highly aspherical lenslets (HAL) are effective in Asian populations but unproven in US children. Objective To evaluate the 24-month safety and effectiveness of HAL spectacle lenses compared with single-vision spectacle lenses (SVL) in US children with myopia. Design, Setting, and Participants This double-masked randomized clinical trial took place at 9 investigational sites in the US and included children aged 6 to 12 years with a manifest spherical equivalent refraction (SER) of −0.75 to −4.50 diopters (D). Key exclusion criteria included a history of prior myopia control intervention, strabismus, amblyopia, or any ocular or systemic conditions and medications affecting refractive status. Enrollment was from December 2021 to July 2022, and the 24-month follow-up reported here was completed in October 2024. Interventions Participants were randomized (1:1) to HAL or SVL. Main Outcomes and Measures Primary outcomes were 24-month changes in cycloplegic SER (cSER) and axial length. Results Of 159 randomized participants (80 [50.3%] male; mean [SD] age, 9.7 [1.6] years), 135 (84.9%) completed the 24-month assessment. The baseline mean (SD) cSER was −2.21 (1.07) D in the HAL group and −2.05 (1.22) D in the SVL group. At 24 months, adjusted mean (SE) myopia progression was −0.25 (0.05) D in the HAL group and −0.90 (0.05) D in the SVL group (difference, 0.64 D; 95% CI, 0.50 to 0.79; <jats:italic>P</jats:italic> &amp;amp;lt; .001), a 71% relative reduction. The baseline mean (SD) axial length was 24.26 (0.92) mm in the HAL group and 24.32 (0.83) mm in the SVL group. Adjusted mean (SE) axial elongation was 0.21 (0.02) mm in the HAL group and 0.45 (0.02) mm in the SVL group (difference, −0.24 mm; 95% CI, −0.29 to −0.19; <jats:italic>P</jats:italic> &amp;amp;lt; .001), a 53% relative reduction. Best-corrected visual acuity was equivalent between groups (mean difference, −0.01 logMAR; 95% CI, −0.02 to 0.00; <jats:italic>P</jats:italic> = .23). Ocular adverse events occurred in 9 of 77 participants the HAL group (11.7%) vs 12 of 82 in the SVL group (14.6%); none were serious or lens related. The total number of subjective symptom reports were 19 (HAL) and 25 (SVL). Conclusions and Relevance In this randomized clinical trial of US children, spectacle lenses with HAL provided a reduction in myopia progression and axial elongation over 24 months. While longer-term data are needed to evaluate sustained treatment efficacy, these findings support HAL as a safe and effective myopia control intervention and underlie US Food and Drug Administration authorization of the study device. Trial Registration ClinicalTrials.gov Identifier: <jats:ext-link xmlns:xlink=\"http://www.w3.org/1999/xlink\" ext-link-type=\"uri\" xlink:href=\"https://clinicaltrials.gov/study/NCT05174780?id=NCT05174780&amp;amp;amp;viewType=Card&amp;amp;amp;rank=1\">NCT05174780</jats:ext-link>","PeriodicalId":14518,"journal":{"name":"JAMA ophthalmology","volume":"16 1","pages":""},"PeriodicalIF":8.1,"publicationDate":"2026-08-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148768022","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}