Currently submitted to: JMIR Research Protocols
Date Submitted: Mar 18, 2026
Open Peer Review Period: Mar 25, 2026 - May 20, 2026
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Imaging-Confirmed Epidemiology of Age-Related Macular Degeneration in Rural Central India: A Hospital-Based Cross-Sectional Study Protocol
ABSTRACT
Background:
Age-related macular degeneration (AMD) is the leading cause of irreversible central vision loss in adults aged 50 years and above. In rural India, its true burden remains substantially underestimated because prior prevalence data relied exclusively on fundoscopy, without confirmatory imaging. The Central India Eye and Medical Study (CIEMS, 2011) reported early AMD in 8.3% of adults aged 60 years and above in rural Wardha, yet no subsequent OCT- or FFA-confirmed estimate exists for this population.
Objective:
This study has three primary objectives: (1) To estimate the imaging-confirmed prevalence of AMD among adults aged 50 years and above attending a rural tertiary care hospital in Central India; (2) To identify demographic, behavioural, and systemic factors independently associated with AMD in this population; and (3) To characterise patterns of diagnostic delay and barriers to eye care in patients with AMD.
Methods:
A hospital-based cross-sectional study will be conducted at the Department of Ophthalmology, Acharya Vinoba Bhave Rural Hospital, Wardha, Maharashtra. Participant recruitment will begin on 20 March 2026 and continue until 19 March 2027, providing a 12-month enrolment period. A minimum of 126 participants will be enrolled through consecutive sampling supplemented by community screening camps. AMD will be graded by two masked retinal specialists using AREDS criteria, with spectral-domain OCT (Cirrus HD-OCT 5000, Carl Zeiss Meditec, Dublin, CA, USA) and fundus fluorescein angiography as confirmatory modalities. The primary outcome is age- and sex-adjusted AMD prevalence. Secondary outcomes include risk factor associations (multivariable logistic regression), diagnostic delay (median delay with nonparametric comparison between recruitment pathways), and visual acuity at first presentation. Inter-grader agreement will be quantified using Cohen's kappa.
Results:
The study was registered with the Clinical Trials Registry of India (CTRI/2026/03/106075) on 12 March 2026. Participant recruitment will begin on 20 March 2026 and continue until 19 March 2027 at Acharya Vinoba Bhave Rural Hospital, Wardha, Maharashtra, India. As this manuscript describes the study protocol, no participants have yet been enrolled. Data analysis is expected to begin in mid-2027, with dissemination of results anticipated in late 2027.
Conclusions:
This study will generate the first imaging-confirmed AMD prevalence data for rural Central India since 2011. Systematic quantification of smokeless tobacco exposure, occupational sunlight, and diagnostic delay will provide actionable evidence for integrating AMD screening into India's National Programme for Control of Blindness and Visual Impairment. Clinical Trial: Clinical Trials Registry of India - CTRI/2026/03/106075 (registered 12 March 2026)
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