Study of Effectiveness of Telemedicine in Identifying Diabetic Retinopathy Cases

The design is a cluster randomized trial of tele-medicine versus usual care in diabetic patients. The primary outcome of the study is the proportion of patients with confirmed DR at Aravind Eye Hospital (AEH). DR will be graded using the International Clinical Diabetic Retinopathy Disease Severity Scale. A sample size of 616 patients in both arms is required to detect a risk ratio of 1.8 or above at 90% power, 1% alpha and a design effect of 2. Eight clinics will be recruited and equally randomized to tele-medicine or usual care stratified by distance from AEH. Inclusion criteria include a confirmed diagnosis of diabetes, age over 50, no retinal exam in the previous year. In the tele-medicine arm patients will be offered fundus imaging and patients diagnosed with DR or probable DR will be counselled to visit AEH to confirm DR. In the usual care arm, the eligible patients will be counselled and referred to undergo an eye examination at AEH. In both the arms the counselling and the awareness creation materials will be standardized. Fundus imaging will be offered at the end of the study to those who refuse initially and all those in the usual arm who did not attend AEH.

Inclusion criteria

• Diabetic patients (as per ICD-9 code 250) in the age group of ≥50 years

Exclusion criteria

• Patients <50 years of age
• Already enrolled as study patients at the diabetes centre
• Patients screened for DR in free camps organized by the diabetes centre
• Diabetic patients who underwent retinal examination in the previous year prior to this intervention
• Patients with disability (physical or mental) who have difficulty in travelling to the eye hospital