Currently submitted to: JMIR Research Protocols
Date Submitted: Mar 7, 2026
Open Peer Review Period: Mar 9, 2026 - May 4, 2026
(currently open for review)
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
Prevalence and Patterns of Ocular Surface Disease Among Glaucoma Patients on Topical Medications: A Prospective Comparative Cross-Sectional Study Protocol
ABSTRACT
Background:
Ocular surface disease (OSD) is a prevalent yet underdiagnosed comorbidity in glaucoma patients undergoing long-term topical therapy. Benzalkonium chloride (BAK), the most commonly used ophthalmic preservative, exerts cytotoxic effects on the corneal and conjunctival epithelium, contributing to tear film instability, goblet cell loss, and chronic inflammation. Despite reported OSD prevalence rates of 30–78% in this population, routine ocular surface screening remains inconsistently implemented in glaucoma clinics. Comprehensive data on OSD burden, clinical subtypes, and treatment gaps in the Indian setting are particularly scarce.
Objective:
This study aims to determine the prevalence and clinical patterns of OSD among glaucoma patients on topical medications, identify associated risk factors (including preservative exposure, polypharmacy, and treatment duration), compare ocular surface parameters with healthy controls, and document existing gaps in OSD screening and management in a tertiary care ophthalmology setting.
Methods:
This is a prospective hospital-based comparative cross-sectional study to be conducted at the Department of Ophthalmology, Acharya Vinoba Bhave Rural Hospital, Sawangi, Wardha, India, from December 2025 to November 2027. A total of 110 participants (55 glaucoma patients on topical therapy and 55 age-matched controls ≥40 years, accounting for 10% attrition) will be enrolled using consecutive sampling. Ocular surface assessment will include the Ocular Surface Disease Index (OSDI) questionnaire, tear breakup time (TBUT), Schirmer's test, and fluorescein/lissamine green ocular surface staining. The study follows the STROBE (Strengthening the Reporting of Observational Studies in Epidemiology) reporting guidelines and has received institutional ethics committee approval (DMIHER(DU)/IEC/2025/375, dated July 9, 2025). The study is registered with the Clinical Trials Registry – India (CTRI/2025/11/098126). A participant flow diagram will be included in the final results manuscript.
Results:
Ethics approval was obtained (DMIHER(DU)/IEC/2025/375; July 9, 2025). The study is prospectively registered with the Clinical Trials Registry – India. Participant enrolment will commence on December 1, 2025. Final results are anticipated in November 2027.
Conclusions:
This protocol describes a systematic approach to quantify the burden of OSD in glaucoma patients receiving topical therapy in an Indian tertiary care center. Findings are expected to inform evidence-based screening protocols and guide integrative management strategies that balance intraocular pressure (IOP) control with ocular surface health. Clinical Trial: Clinical Trials Registry – India (CTRI/2025/11/098126; November 26, 2025).
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