NCT02085681

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
801

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 5, 2014

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 13, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

April 22, 2015

Status Verified

April 1, 2015

Enrollment Period

8 months

First QC Date

February 5, 2014

Last Update Submit

April 21, 2015

Conditions

Diabetic Retinopathy

Keywords

Diabetic RetinopathyScreeningTele-medicineRetinal ImagingRemote diagnosis

Outcome Measures

Primary Outcomes (1)

  • Proportion of patients with confirmed Diabetic Retinopathy (DR) diagnosed at the eye hospital

    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.

    6 months

Secondary Outcomes (3)

  • The severity of diabetic retinopathy (DR)

    6 months

  • The acceptance rate for referral in each arm

    6 months

  • Proportion of patients eligible for referral who had DR and who did not attend

    6 months

Other Outcomes (2)

  • Barriers to compliance

    6 months

  • Drivers of acceptance

    6 months

Study Arms (2)

Tele-medicine

EXPERIMENTAL

Tele-medicine aided retinal imaging and referral to eye hospital

Other: Tele-medicine

Conventional Referral

OTHER

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

Interventions

Tele-medicineOTHER

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.

Also known as: Tele-medicine aided retinal imaging
Tele-medicine
Conventional referralOTHER

All eligible patients in the conventional arm will be counselled on the importance of eye screening and will be referred to the eye hospital

Conventional Referral

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aravind Eye Hospital

Madurai, Tamil Nadu, 625020, India

Location

Related Publications (1)

  • Joseph S, Kim R, Ravindran RD, Fletcher AE, Ravilla TD. Effectiveness of Teleretinal Imaging-Based Hospital Referral Compared With Universal Referral in Identifying Diabetic Retinopathy: A Cluster Randomized Clinical Trial. JAMA Ophthalmol. 2019 Jul 1;137(7):786-792. doi: 10.1001/jamaophthalmol.2019.1070.

    PMID: 31070699DERIVED

MeSH Terms

Conditions

Diabetic Retinopathy

Interventions

Telemedicine

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Delivery of Health CarePatient Care ManagementHealth Services Administration

Study Officials

  • Sanil Joseph, MHA, MSc

    Lions Aravind Institute of Community Ophthalmology, Aravind Eye Hospital, Madurai, India

    PRINCIPAL INVESTIGATOR

  • 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

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Faculty

Study Record Dates

First Submitted

February 5, 2014

First Posted

March 13, 2014

Study Start

May 1, 2014

Primary Completion

January 1, 2015

Study Completion

March 1, 2015

Last Updated

April 22, 2015

Record last verified: 2015-04

Locations

IN(1)