Xindi Chen , Louay Almidani , Seema Banerjee , Jonathan Thomas , Aleksandra Mihailovic , Fasika A. Woreta , Pradeep Y. Ramulu
{"title":"Associations Between Visual Impairment and Homebound Status, Home Hazards, and Support Service Utilization: The National Health and Aging Trends Study","authors":"Xindi Chen , Louay Almidani , Seema Banerjee , Jonathan Thomas , Aleksandra Mihailovic , Fasika A. Woreta , Pradeep Y. Ramulu","doi":"10.1016/j.ajo.2025.09.005","DOIUrl":"10.1016/j.ajo.2025.09.005","url":null,"abstract":"<div><h3>Objective</h3><div>To examine the association between visual impairment (VI) and (1) homebound status, (2) presence of home hazards, and (3) utilization of home-based long-term services and supports (LTSS) among older adults. Design: Longitudinal and cross-sectional analyses using National Health and Aging Trends Study (NHATS) data (2021–2023).</div></div><div><h3>Subjects</h3><div>A total of 3022 Medicare beneficiaries aged ≥71 years (mean age 78.8 years, 55.3% female) with complete data on homebound status and visual function.</div></div><div><h3>Methods</h3><div>VI was defined as impairment in distance visual acuity or near visual acuity (<0.3 logMAR), or in contrast sensitivity (<1.55 logCS). Homebound status was classified as homebound, semi-homebound, or non-homebound based on frequency and difficulty leaving home. Home hazards (peeling paint, broken furniture, flooring damage, and tripping hazards) were documented during in-home visits. LTSS utilization encompassed assistive devices, home modifications, transportation services, senior housing, meal delivery, paid care, and high-burden family caregiving. Regression models (logistic and Cox proportional hazards) assessed cross-sectional and longitudinal relationships between VI – its presence, severity, and rate of decline – and outcomes.</div></div><div><h3>Main Outcome Measures</h3><div>Presence or transition to homebound or semi-homebound status, presence of home safety hazards, and utilization of home-based LTSS.</div></div><div><h3>Results</h3><div>Among 3,022 participants (mean age 78.8 years, 55.3% female), 5.7% were homebound, and 14.4% semi-homebound. The presence of any VI was associated with a higher likelihood of both being (OR = 1.52, 95% CI: 1.17-1.98, <em>P</em> = .002) and becoming homebound or semi-homebound (HR = 1.35, 95% CI: 1.04-1.74, <em>P</em> = .02). Participants meeting all three VI criteria had an even higher risk (HR = 1.86, 95% CI: 1.35-2.58, <em>P</em> < .001). Individuals with VI were more likely to have home hazards (OR = 1.88, 95% CI: 1.32-2.69, <em>P</em> = .001) and utilize home-based LTSS (OR = 1.35, 95% CI: 1.10-1.66, <em>p</em> = 0.005).</div></div><div><h3>Conclusions</h3><div>VI is a significant risk factor for being and becoming homebound in older adults, with increasing severity and breadth of VI compounding this risk. Individuals with VI also face greater home hazards and require more home-based LTSS, suggesting challenges maintaining home safety and functionality as they become more confined to the home. Early vision interventions, comprehensive home safety assessments, and targeted LTSS may be important preventive strategies for maintaining independence in visually impaired older adults.</div></div>","PeriodicalId":7568,"journal":{"name":"American Journal of Ophthalmology","volume":"281 ","pages":"Pages 52-62"},"PeriodicalIF":4.2,"publicationDate":"2025-09-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145008709","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}
Mengxi Shen , Alessandro Berni , Jeremy Liu , Farhan Hiya , Gissel Herrera , Omar S. El-Mulki , Sara Beqiri , Yuxuan Cheng , James Kastner , Omer Trivizki , Sivathanu Kumar , Yi Zhang , Viet Hoan Le , Robert C. O'Brien , Maura Di Nicola , Zohar Yehoshua , Sander R. Dubovy , Ruikang K. Wang , Giovanni Gregori , Philip J. Rosenfeld
{"title":"Real-World Experience With Intravitreal Pegcetacoplan for the Treatment of Geographic Atrophy in Age-Related Macular Degeneration","authors":"Mengxi Shen , Alessandro Berni , Jeremy Liu , Farhan Hiya , Gissel Herrera , Omar S. El-Mulki , Sara Beqiri , Yuxuan Cheng , James Kastner , Omer Trivizki , Sivathanu Kumar , Yi Zhang , Viet Hoan Le , Robert C. O'Brien , Maura Di Nicola , Zohar Yehoshua , Sander R. Dubovy , Ruikang K. Wang , Giovanni Gregori , Philip J. Rosenfeld","doi":"10.1016/j.ajo.2025.09.006","DOIUrl":"10.1016/j.ajo.2025.09.006","url":null,"abstract":"<div><h3>Purpose</h3><div>To report on the real-world experience of using intravitreal pegcetacoplan for the treatment of geographic atrophy (GA) in age-related macular degeneration (AMD).</div></div><div><h3>Design</h3><div>Retrospective interventional case series.</div></div><div><h3>Methods</h3><div>Eyes with symptomatic GA secondary to AMD were treated with 15 mg of intravitreal pegcetacoplan and participated in an ongoing prospective swept-source optical coherence tomography angiography (SS-OCTA) imaging study. All eyes underwent SS-OCTA imaging before and during pegcetacoplan therapy to assess for GA lesion size, the presence of nonexudative macular neovascularization (MNV), and the onset of exudation. The growth rate of GA and best-corrected visual acuity (BCVA) were assessed for eyes followed for 1 year.</div></div><div><h3>Results</h3><div>From April 12, 2023, to November 11, 2024, 154 eyes were injected with pegcetacoplan, and 103 eyes had 1-year follow-up. At baseline, 11 eyes had been previously treated with anti-VEGF therapy, and 9 eyes were diagnosed with treatment-naïve nonexudative MNV by SS-OCTA. Each eye received an average of 10 ± 2 injections, with an average interval of 1.2 months between injections. For the 97 eyes with 1 year of follow-up and measurable GA, the square-root (sqrt) GA growth rate after pegcetacoplan treatment was 0.24 ± 0.15 mm/year. Of these 97 eyes, 63 eyes had prior annual visits before pegcetacoplan treatment was started. In these eyes, the annual sqrt GA growth rate was 0.33 ± 0.22 mm/year before pegcetacoplan and 0.21 ± 0.12 mm/year after pegcetacoplan, resulting in a 37% decrease in the growth rate (<em>P</em> < .001). There were no significant differences in GA growth rate between foveal and nonfoveal GA, either before or after the use of pegcetacoplan (all <em>P</em> ≥ .80). The mean BCVA declined from 63 ± 14 to 59 ± 15 letters over 1 year (<em>P</em> = .001), with no significant difference between foveal and nonfoveal GA (<em>P</em> = .36). Among the 29 eyes developing exudation during pegcetacoplan treatment, 19 (66%) had no evidence of any detectable MNV at baseline and during treatment on SS-OCTA.</div></div><div><h3>Conclusions</h3><div>Eyes treated with pegcetacoplan after 1 year had a 37% reduction in GA growth rate compared with their prior annual growth rate. Pegcetacoplan slowed the growth for foveal and nonfoveal GA at a similar rate. Most of the pegcetacoplan-associated exudation was not due to detectable MNV.</div></div>","PeriodicalId":7568,"journal":{"name":"American Journal of Ophthalmology","volume":"281 ","pages":"Pages 31-41"},"PeriodicalIF":4.2,"publicationDate":"2025-09-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145008706","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}
Simon Elsliger , Maya Sebag , Wissam B Nassrallah , Moncef Berkache , Allison Bernstein , Dominique Geoffrion , Rayan Tolba , Amir Abd Elkader , Mona Harissi-Dagher
{"title":"The Risk of Retinal Detachment Following Boston Keratoprosthesis Type 1 Implantation: Insights From a Retrospective Case Review","authors":"Simon Elsliger , Maya Sebag , Wissam B Nassrallah , Moncef Berkache , Allison Bernstein , Dominique Geoffrion , Rayan Tolba , Amir Abd Elkader , Mona Harissi-Dagher","doi":"10.1016/j.ajo.2025.09.007","DOIUrl":"10.1016/j.ajo.2025.09.007","url":null,"abstract":"<div><h3>Purpose</h3><div>To evaluate the incidence, risk factors, management strategies, and visual outcomes of retinal detachment (RD) following Boston Keratoprosthesis Type 1 (KPro) implantation.</div></div><div><h3>Design</h3><div>Single-center, retrospective observational case series.</div></div><div><h3>Methods</h3><div>Medical records of 157 eyes from 122 adult patients who underwent Boston Type 1 KPro implantation at a tertiary care center between 2008 and 2022 were reviewed. Inclusion criteria included age ≥18 years and postoperative follow-up of at least 1 year. Demographic data, preoperative characteristics, postoperative complications, and visual outcomes were collected. Univariate and multivariate statistical analyses were conducted to identify significant risk factors for RD. Cox regression and Kaplan–Meier survival analysis were used to evaluate time-to-event data.</div></div><div><h3>Results</h3><div>Of the 157 eyes that underwent Boston Type 1 KPro implantation, 27 eyes (17.2%) developed retinal detachment (RD), all within 8 years postoperatively (2 RD per 100 eye years). Aniridia was significantly associated with increased RD risk (OR: 2.79; 95% CI: 1.23-6.70), while other preoperative diagnoses were not. Eyes with RD were more likely to experience hypotony (OR: 7.63; <em>P</em> < .0001), choroidal detachment (OR: 7.67; <em>P</em> < .0001), phthisis (OR: 7.69; <em>P</em> < .0001), and other serious complications. Surgical intervention was possible in 16 of the 27 RD cases, with pneumatic retinopexy being the most common approach.</div></div><div><h3>Conclusions</h3><div>Retinal detachment is a significant complication following KPro implantation, particularly in patients with aniridia. Postoperative hypotony and other inflammatory complications may contribute to increased RD risk and challenge surgical repair. Close monitoring of high-risk patients may help mitigate long-term visual morbidity.</div></div>","PeriodicalId":7568,"journal":{"name":"American Journal of Ophthalmology","volume":"281 ","pages":"Pages 1-9"},"PeriodicalIF":4.2,"publicationDate":"2025-09-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145008701","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}
XUERUI ZHANG , YU XU , WENTING ZHANG , YUAN YANG , JIAWEI YIN , HUANYU LIU , VICTORIA Y. GU , HAODONG XIAO , SHIPENG GUO , JIE PENG , PEIQUAN ZHAO
{"title":"Innovative Non-Inverted ILM Free Flap Covering Technique for Unclosed Macular Hole Repair","authors":"XUERUI ZHANG , YU XU , WENTING ZHANG , YUAN YANG , JIAWEI YIN , HUANYU LIU , VICTORIA Y. GU , HAODONG XIAO , SHIPENG GUO , JIE PENG , PEIQUAN ZHAO","doi":"10.1016/j.ajo.2025.09.002","DOIUrl":"10.1016/j.ajo.2025.09.002","url":null,"abstract":"<div><h3>Objective</h3><div>To examine the safety and effectiveness of non-inverted ILM Free Flap combined with the SPOT technique (<u>S</u>ub-<u>P</u>erfluorocarbon liquid (PFCL) injection of <u>O</u>cular viscoelastic device (OVD) <u>T</u>echnique) in the treatment of unclosed macular holes (MHs).</div></div><div><h3>Design</h3><div>Retrospective interventional case series.</div></div><div><h3>Participants</h3><div>Eight patients (8 eyes) with persistent unclosed MHs were treated at a tertiary eye hospital in China from September 2023 to February 2025. All procedures were performed by the same vitreoretinal surgeon (P.Q.Z.).</div></div><div><h3>Methods</h3><div>Enhanced ILM peeling and a limited ILM flap harvested outside the peeling margin to cover the MH. A combination of PFCL and OVD (SPOT technique) was applied to stabilize the ILM flap.</div></div><div><h3>Main Outcomes and Measures</h3><div>Primary outcome was anatomical closure of the MH within 1 month postoperatively. Secondary outcomes included best-corrected visual acuity (BCVA) and structural restoration of the external limiting membrane (ELM), outer nuclear layer (ONL), and ellipsoid zone (EZ) on optical coherence tomography (OCT).</div></div><div><h3>Results</h3><div>All MHs achieved anatomical closure within 1 month. U-shaped closure was noted in 6 eyes (75%) and V-shaped in 2 eyes (25%). BCVA improved in all eyes at final follow-up. OCT showed reconstitution of the ELM, ONL, and EZ bands in all cases.</div></div><div><h3>Conclusions</h3><div>These findings demonstrate that the innovative combination of the non-inverted, single-layered ILM-free flap with the SPOT technique is effective in treating unclosed MH and improving VA. This approach offers a new solution for unclosed MH and its effectiveness needs to be validated by more well-designed research.</div></div>","PeriodicalId":7568,"journal":{"name":"American Journal of Ophthalmology","volume":"281 ","pages":"Pages 72-77"},"PeriodicalIF":4.2,"publicationDate":"2025-09-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145007088","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":"Scorpion Venom Peptides in Ophthalmology: Insights from the Babylonian Talmud","authors":"David Maskill , Robert Morgan Blizzard","doi":"10.1016/j.ajo.2025.08.054","DOIUrl":"10.1016/j.ajo.2025.08.054","url":null,"abstract":"<div><div>Historical medical texts can reveal overlooked therapeutic approaches relevant to modern ophthalmology. This perspective revisits a remedy from the Babylonian Talmud prescribing a mixture of scorpion and kohl for an eye condition called <em>buruqti</em> (also transliterated as <em>beroketi</em>), traditionally translated as cataract. Through philologic, zoologic, and pathologic analysis, we argue that <em>buruqti</em> likely refers to a corneal or conjunctival lesion rather than a true lens opacity. The description within the remedy of the scorpion’s “seven-beaded tail” is interpreted symbolically within the cultural and mystical framework of Late Antiquity. This ancient preparation, although not adopted in later medical texts, raises intriguing possibilities for the use of arachnid venom peptides in ocular disease. These peptides possess antimicrobial, immunomodulatory, and antiangiogenic properties with emerging potential for treating inflammatory and degenerative eye disorders. This article highlights the intersection of historical scholarship and modern biomedical research, suggesting that ancient remedies can inspire novel pharmacologic strategies. We thereby aim to expand the conceptual horizons of ophthalmic drug discovery and encourage exploration of venom-derived peptides as next-generation therapeutics.</div></div>","PeriodicalId":7568,"journal":{"name":"American Journal of Ophthalmology","volume":"281 ","pages":"Pages 25-30"},"PeriodicalIF":4.2,"publicationDate":"2025-09-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144995919","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}
CATHERINE P. AGATHOS, NATELA M. SHANIDZE, DONALD C. FLETCHER
{"title":"Importance of Screening for Contrast Sensitivity, Falls, and Mobility Limitations in Older Adults With Maculopathy","authors":"CATHERINE P. AGATHOS, NATELA M. SHANIDZE, DONALD C. FLETCHER","doi":"10.1016/j.ajo.2025.08.051","DOIUrl":"10.1016/j.ajo.2025.08.051","url":null,"abstract":"<div><h3>Objective</h3><div>Assess the potential value of adding questions on falls/balance difficulties due to vision loss and testing contrast sensitivity (CS) in patients with maculopathy (mainly age-related macular degeneration, AMD) to help guide referral for mobility rehabilitation.</div></div><div><h3>Design</h3><div>Cross-sectional study.</div></div><div><h3>Participants</h3><div>A total of 125 patients over 55 years old with binocular maculopathy and intact peripheral vision presenting for a low vision rehabilitation consultation.</div></div><div><h3>Methods</h3><div>Patients were asked questions regarding difficulties with their balance and mobility, including the 9-item Glaucoma Activity Limitation questionnaire (GAL-9). For analysis, patients were grouped by visual impairment severity using better-eye visual acuity (VA) and binocular CS.</div></div><div><h3>Main Outcome Measures</h3><div>Visual function, self-reported balance and mobility difficulties, falls history, and rehabilitation referrals were examined across visual impairment severity groups.</div></div><div><h3>Results</h3><div>Total 52% of patients reported balance or gait difficulties and 36% attributed mobility limitations to vision loss. Increasing vision deficit severity related to greater mobility concerns (>50% of patients in the severe categories rated difficulty as 3/5 or higher) and higher referral rates. Scores on the GAL-9 increased with greater vision loss and were predicted by CS, female sex, larger relative scotomata and falls history (R<sup>2</sup> = 0.45, <em>P</em> < .0001). CS was a better predictor of mobility difficulties than VA. Based on reported concerns, 31.2% of patients were referred to orientation and mobility training and/or physical therapy (>50% in the severe groups).</div></div><div><h3>Conclusions</h3><div>Mobility limitations and falls affect a substantial proportion of AMD patients yet may go undiscussed in eye clinics. Incorporating screening questions and explicit discussion of mobility difficulties in clinical practice in maculopathy can help elucidate patient mobility limitations. Realization of these limitations is the prerequisite to initiate appropriate referrals to low vision and mobility specialists to improve mobility and manage falls risk. Clinical practice may also benefit from assessment of CS as this is a better indicator of difficulties in daily living. Our results, along with prior literature, underscore the need to recognize the role of central vision loss, and vision loss more broadly, in mobility decline. Thus, a central vision loss-specific mobility questionnaire may be needed to facilitate patient screening in the future.</div></div>","PeriodicalId":7568,"journal":{"name":"American Journal of Ophthalmology","volume":"280 ","pages":"Pages 481-492"},"PeriodicalIF":4.2,"publicationDate":"2025-08-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144938965","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}
Jim Shenchu Xie, Hargun Kaur, Adrien Lusterio, Haoran Charles Li, Taranah Adli, Omar Taboun, Amy Basilious, Allison Angold-Stephens, Samuel Masket, Rookaya Mather
{"title":"A Scoping Review of Ergonomics in Ophthalmology: Working Smarter.","authors":"Jim Shenchu Xie, Hargun Kaur, Adrien Lusterio, Haoran Charles Li, Taranah Adli, Omar Taboun, Amy Basilious, Allison Angold-Stephens, Samuel Masket, Rookaya Mather","doi":"10.1016/j.ajo.2025.08.053","DOIUrl":"https://doi.org/10.1016/j.ajo.2025.08.053","url":null,"abstract":"<p><strong>Topic: </strong>Work-related musculoskeletal disorders (WMSDs) are prevalent among ophthalmologists due to maladaptive working postures. This review summarizes published ergonomic optimization strategies to mitigate WMSD risk in ophthalmology.</p><p><strong>Clinical relevance: </strong>WMSDs can lead to career-interrupting or career-ending disabilities in ophthalmologists. There is a need for summative research on ophthalmology-specific strategies to reduce WMSD risk such as: utilizing ergonomically designed microscopes, workflows and workspaces, adopting ergonomic best practices, and engaging in injury prevention training. This scoping review aims to consolidate all ophthalmology-specific WMSD prevention strategies published in the literature to provide a practical resource for ophthalmologists and foundation for future research.</p><p><strong>Methods: </strong>A systematic search was conducted in Medline (Ovid), Embase (Ovid), CENTRAL, Scopus, CINAHL, and Web of Science from inception to June 2023. Primary and secondary research articles, as well as conference abstracts, were included if they assessed at least one ergonomics-related outcome in ophthalmology. Reference lists of included studies were hand-searched for additional relevant literature.</p><p><strong>Results: </strong>Of 3,596 retrieved articles, 33 epidemiologic studies, 36 interventional studies, and 25 secondary research articles met inclusion criteria. Factors associated with reduced WMSD risk included system and individual factors such as ergonomic equipment design and workspace ergonomics, optimizing personal working postures, and individual physical endurance.</p><p><strong>Conclusions: </strong>WMSDs in ophthalmologists are primarily linked to forward head posture at the slit lamp and operating microscope. Published injury prevention strategies include: the use of ergonomically designed digital operating microscopes that do not require forward head posture, injury prevention education for ophthalmologists, maintenance of individual physical fitness and the adoption of ergonomic recommendations suggested by many authors. Gaps in the literature include: evidence on the efficacy of these strategies, formal ergonomic best practice guidelines and subspecialty-specific ergonomic recommendations. Based on the literature reviewed, the authors propose an evidence-informed framework for improving ergonomics and reducing WMSDs for ophthalmologists, trainees, and institutions.</p>","PeriodicalId":7568,"journal":{"name":"American Journal of Ophthalmology","volume":" ","pages":""},"PeriodicalIF":4.2,"publicationDate":"2025-08-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144938929","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}
MITCHELL C. SHULTZ , WILLIAM F. WILEY , EVA LIANG , ALICE T. EPITROPOULOS , JEFFREY WHITMAN
{"title":"Visual and Patient-Reported Outcomes of a Novel Full Visual Range Intraocular Lens Versus a Monofocal Intraocular Lens: A Randomized Multicenter US Trial","authors":"MITCHELL C. SHULTZ , WILLIAM F. WILEY , EVA LIANG , ALICE T. EPITROPOULOS , JEFFREY WHITMAN","doi":"10.1016/j.ajo.2025.08.050","DOIUrl":"10.1016/j.ajo.2025.08.050","url":null,"abstract":"<div><h3>Purpose</h3><div>To compare the visual, refractive, and patient-reported outcomes following bilateral implantation of a novel full visual range (FVR) intraocular lens (IOL) and a monofocal IOL in subjects undergoing cataract surgery.</div></div><div><h3>Design</h3><div>Prospective, masked, multicenter, controlled pivotal trial.</div></div><div><h3>Methods</h3><div>Subjects scheduled to undergo cataract surgery were randomized to bilateral implantation of a novel FVR IOL (enVista Envy MX60EF, Bausch + Lomb; N = 332) or enVista monofocal IOL (MX60E; N = 169). Primary effectiveness endpoints were monocular corrected distance visual acuity (CDVA, 4 m), distance-corrected intermediate (DCIVA, 66 cm), and near (DCNVA, 40 cm) visual acuity, and secondary effectiveness endpoints were binocular DCIVA, DCNVA, uncorrected intermediate (UIVA), and near visual acuity (UNVA), at postoperative days 120 to 180.</div></div><div><h3>Results</h3><div>The noninferiority of the FVR IOL group for monocular CDVA and statistical superiority for monocular DCIVA and DCNVA over the monofocal group were established. Binocular UIVA, DCIVA, UNVA, and DCNVA were also better in the FVR group compared to the monofocal group (all <em>P</em> < .0001). Mean postoperative MRSE was −0.14 ± 0.39 D (FVR) and −0.14 ± 0.40 D (monofocal group). The FVR group showed consistent visual acuity of ∼0.1 logMAR from −1.50 to −2.50 D. The difference in mesopic contrast sensitivity (without glare) between the 2 groups at 1.5, 3, and 12 cpds was less than the minimum detectable difference of 0.15 logCS.</div></div><div><h3>Conclusions</h3><div>Compared to the monofocal group, the FVR IOL group exhibited superior monocular DCNVA and DCIVA, with comparable CDVA. Binocular visual acuity was 0.09 logMAR or better (∼20/25) from distance to near (−0.5 D to −2.5 D).</div></div>","PeriodicalId":7568,"journal":{"name":"American Journal of Ophthalmology","volume":"280 ","pages":"Pages 493-507"},"PeriodicalIF":4.2,"publicationDate":"2025-08-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144939047","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}