SMART (artificial intelligence enabled) DROP (diabetic retinopathy outcomes and pathways): Study protocol for diabetic retinopathy management.

INTRODUCTION

Delayed diagnosis of diabetic retinopathy (DR) remains a significant challenge, often leading to preventable blindness and visual impairment. Given that physicians are frequently the first point of contact for people with diabetes, there is a critical need for integrated screening programs within diabetes clinics to enhance DR management and reduce the risk of severe vision loss.

METHODS AND ANALYSIS: We will conduct a prospective cohort study comparing (i) the intervention cohort, screened at diabetes clinics and referred to eye clinics per the proposed pathway, and (ii) the standard-of-care (SOC) eye clinic cohort. The study will be conducted in Hyderabad, India, at LV Prasad Eye Institute and four IDEA (Institute of Diabetes, Endocrinology, and Adiposity) Clinics. The primary objective is to evaluate the effectiveness of a systematic diabetic retinopathy screening program in achieving earlier detection and reducing visual impairment among People With Diabetes (PWD) attending IDEA clinics compared to routine care at eye care settings. The screening program will be operationalized using AI-enabled tools and supported by trained non-medical technicians. We will perform visual acuity tests and non-mydriatic fundus photography using AI-assisted cameras. DR-positive patients will be referred for treatment and follow-up. We aim to achieve high accuracy (>90%) in appropriate referral of DR and high screening coverage (>80%) of eligible PWD. Success metrics include screening uptake, AI diagnostic accuracy, referral rates, cost-effectiveness, patient satisfaction, follow-up adherence, and long-term outcomes.

CONCLUSION

This study aims to enhance diabetic retinopathy screening and management through an AI-enabled approach at diabetes clinics, improving early detection and care pathways. The findings will contribute to evidence-based strategies for optimizing DR screening and management, with results disseminated through peer-reviewed publications to inform policy and practice.

TRIAL REGISTRATION: Trial registration number: CTRI/2024/03/064518 [Registered on: 20/03/2024] (https://ctri.nic.in/).