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Abstract

Importance
Hospital-based ophthalmology faces increasing demand for long-term monitoring of neovascular age-related macular degeneration (nAMD). Safe redistribution of routine monitoring to community clinicians is relevant to integrated community (primary)–secondary care models.

Objective
To examine whether community optometrist–led monitoring of nAMD is noninferior to hospital-based monitoring for detecting disease activity requiring treatment.

Design, Setting, and Participants
This multicenter, noninferiority randomized clinical trial was conducted from October 8, 2019, to January 31, 2024, at secondary centers (17 hospitals) and primary centers (60 community optometry practices) with 12-month follow-up. Statisticians were masked to patient grouping. Adults 55 years or older with quiescent AMD in at least 1 eye (and quiescent or nonneovascular disease in the other) were recruited at participating hospitals. Data analysis was performed from October 2024 to March 2025.

Interventions
Participants were randomized 1:1 to monitoring sessions once every 2 months in hospitals (control) or community practices (intervention). Trained and accredited optometrists performed optical coherence tomography imaging, clinical examination, patient management, and online reporting at each visit.

Main Outcomes and Measures
The primary outcome (participant level) was a binary indicator of whether a false-negative clinical management decision occurred at any visit within 12 months (missed quiescent nAMD reactivation or new fellow-eye nAMD, adjudicated by a central reading-center reference standard). The noninferiority margin was a 10–percentage point absolute risk difference. Secondary outcomes were false-positive clinical management decisions, attendance adherence, visual acuity change, harms, loss to follow-up, suspicious classifications, and confirmation visit outcomes.

Results
Of 704 randomized participants, 635 (90.2%) completed at least 1 follow-up visit, including 287 at community practices (mean [SD] age, 80.6 [8.1] years; 236 [67.4%] female) and 348 at hospitals (mean [SD] age, 80.1 [8.5] years; 203 [57.3%] female). False-negative clinical management decisions occurred in 11 of 287 community participants (3.8%) vs 27 of 348 hospital participants (7.8%) (risk difference, −3.9 percentage points; 95% CI, −7.4 to −0.3 percentage points; P = .04; adjusted odds ratio, 0.51; 95% CI, 0.24-1.07; P = .08), meeting noninferiority. False-positive clinical management decisions occurred in 24 of 287 community participants (8.4%) vs 12 of 348 hospital participants (3.5%) (risk difference, 4.9 percentage points; 95% CI, 0.9-9.0 percentage points). Findings were consistent across per-protocol, cluster-adjusted, and relative risk sensitivity analyses. No adverse event–related withdrawals occurred.

Conclusions and Relevance
In this randomized clinical trial, community optometrist–led monitoring of quiescent nAMD was noninferior to hospital monitoring for detecting disease activity requiring treatment. These results provide evidence for its use in integrated clinical care models.

Publication Type:	Article
Additional Information:	This is an open access article distributed under the terms of the CC-BY-NC-ND License, which does not permit alteration or commercial use, including those for text and data mining, AI training, and similar technologies. © 2026 Sharma A et al. JAMA Network Open.
Subjects:	R Medicine > RE Ophthalmology
Departments:	School of Health & Medical Sciences School of Health & Medical Sciences > Department of Optometry & Visual Science
SWORD Depositor:	Symplectic Administrator

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