Study of Effectiveness of Telemedicine in Identifying Diabetic Retinopathy Cases (DRTM)
|ClinicalTrials.gov Identifier: NCT02085681|
Recruitment Status : Completed
First Posted : March 13, 2014
Last Update Posted : April 22, 2015
The aim of this study is to compare the effectiveness of identifying diabetic retinopathy using tele-medicine based Digital Retinal Imaging in Diabetes Clinics with that of the conventional referral system.
Hypothesis: Tele-medicine based digital retinal imaging involving a diabetes centre will identify proportionately more diabetic patients with DR and lead to higher acceptance rate with subsequent ophthalmic referral and management
|Condition or disease||Intervention/treatment||Phase|
|Diabetic Retinopathy||Other: Tele-medicine Other: Conventional referral||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||801 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||Effectiveness of Tele-medicine in Identifying Diabetic Retinopathy Cases Attending Diabetologists' Clinics Compared to the Conventional Referral System|
|Study Start Date :||May 2014|
|Actual Primary Completion Date :||January 2015|
|Actual Study Completion Date :||March 2015|
Tele-medicine aided retinal imaging and referral to eye hospital
Patients at the diabetes clinics will be subjected to non-mydriatic retinal imaging and the images will be transferred to the eye hospital via internet using a specified software - Aravind Diabetic Retinopathy Evaluation Software (ADRES) that enables a retinal specialist to read and grad the image and send the feedback immediately to the diabetes clinic. Based on the presence or absence of DR the patients will be referred to the eye hospital for detailed retinal examination.
Other Name: Tele-medicine aided retinal imaging
Patients will be counselled on the importance of eye examination and will be referred to the eye hospital in the conventional manner.
Other: Conventional referral
All eligible patients in the conventional arm will be counselled on the importance of eye screening and will be referred to the eye hospital
- Proportion of patients with confirmed Diabetic Retinopathy (DR) diagnosed at the eye hospital [ Time Frame: 6 months ]Out of the patients referred from the diabetes clinics to the eye hospital, the number of patients with confirmed DR will be measured. This proportion will be compared between the two arms.
- The severity of diabetic retinopathy (DR) [ Time Frame: 6 months ]Among patients confirmed with DR, the severity of the disease will be measured using standard classification (Diabetic Retinopathy Disease Severity Scale) approved by the American Academy of Ophthalmology
- The acceptance rate for referral in each arm [ Time Frame: 6 months ]Out of the patients referred from the diabetes clinic, the number of patients actually reported to the eye hospital will be measured.
- Proportion of patients eligible for referral who had DR and who did not attend [ Time Frame: 6 months ]Patients who are referred by not attended to the eye hospital will be followed up and examined to find out what proportion of them actually as DR
- Barriers to compliance [ Time Frame: 6 months ]Patients will be interviewed to identify the barriers to compliance following the referral
- Drivers of acceptance [ Time Frame: 6 months ]Patients will be interviewed to identify the factors that encouraged them to visit the eye hospital following referral
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02085681
|Aravind Eye Hospital|
|Madurai, Tamil Nadu, India, 625020|
|Principal Investigator:||Sanil Joseph, MHA, MSc||Lions Aravind Institute of Community Ophthalmology, Aravind Eye Hospital, Madurai, India|
|Study Chair:||Ramasamy Kim, DO, DNB||Aravind Eye Hospital, Madruai, India|
|Study Chair:||Thulasiraj Ravilla, MBA||Lions Aravind Institute of Community Ophthalmology, Aravind Eye Hospital, Madurai|
|Study Chair:||Astrid Fletcher, MSc, PhD||London School of Hygiene and Tropical Medicine|