Diabetic RetinopathyDRTMNCT02085681
Study of Effectiveness of Telemedicine in Identifying Diabetic Retinopathy Cases
A study testing Tele-medicine and Conventional referral in people with Diabetic Retinopathy, run by Aravind Eye Care System at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Diabetic Retinopathy
- What is being tested?
- Tele-medicine and Conventional referral
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 801 participants
- Where
- 1 siteIndia
- Study dates
- May 2014to Mar 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diabetic patients (as per ICD-9 code 250) in the age group of ≥50 years
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Tele-medicine in Identifying Diabetic Retinopathy Cases Attending Diabetologists' Clinics Compared to the Conventional Referral System
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
Read the detailed description
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.
- Conditions
- Diabetic Retinopathy
- Being tested
- Tele-medicine, Conventional referral
- Keywords
- Diabetic Retinopathy, Screening, Tele-medicine, Retinal Imaging, Remote diagnosis
- Medical subject headings
- Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tele-medicineOther
Also called Tele-medicine aided retinal imaging
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.
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
| Study group | Role | What they receive |
|---|---|---|
| Tele-medicine | Experimental | Tele-medicine aided retinal imaging and referral to eye hospital Receives: 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. Receives: Other: Conventional referral |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (3)
The severity of diabetic retinopathy (DR)
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
Measured: 6 months
The acceptance rate for referral in each arm
Out of the patients referred from the diabetes clinic, the number of patients actually reported to the eye hospital will be measured.
Measured: 6 months
Proportion of patients eligible for referral who had DR and who did not attend
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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2014 (estimated)
- Study startMay 2014
- Primary completionJan 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetic RetinopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 801 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aravind Eye Care System
- Sponsor type
- University, hospital or other
- Collaborators
- London School of Hygiene and Tropical Medicine
- Responsible party
- Principal investigator, Sanil Joseph, Aravind Eye Care System
- Investigators
- Sanil Joseph, MHA, MSc, Principal investigator, Lions Aravind Institute of Community Ophthalmology, Aravind Eye Hospital, Madurai, IndiaRamasamy Kim, DO, DNB, Study chair, Aravind Eye Hospital, Madruai, IndiaThulasiraj Ravilla, MBA, Study chair, Lions Aravind Institute of Community Ophthalmology, Aravind Eye Hospital, MaduraiAstrid Fletcher, MSc, PhD, Study chair, London School of Hygiene and Tropical Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02085681
- Sponsor's protocol ID
- WT097685MA
- Acronym
- DRTM
- Status last verified
- Apr 2015
- First submitted
- 5 Feb 2014
- Last updated
- 22 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 31070699
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Tele-medicine in Identifying Diabetic Retinopathy Cases Attending Diabetologists' Clinics Compared to the Conventional Referral System
- ClinicalTrials.gov ID
- NCT02085681
- Acronym / sponsor ID
- DRTM / WT097685MA
- Conditions
- Diabetic Retinopathy
- Keywords
- Diabetic Retinopathy, Screening, Tele-medicine, Retinal Imaging, Remote diagnosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 801 participants (actual)
- Lead sponsor
- Aravind Eye Care SystemUniversity, hospital or other
- Collaborators
- London School of Hygiene and Tropical Medicine
- Study start
- May 2014
- Primary completion
- Jan 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 13 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tele-medicine | Experimental | Other: Tele-medicineTele-medicine aided retinal imaging and referral to eye hospital |
| Conventional Referral | Other | Other: Conventional referralPatients will be counselled on the importance of eye examination and will be referred to the eye hospital in the conventional manner. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diabetic patients (as per ICD-9 code 250) in the age group of ≥50 years
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tele-medicineAlso: Tele-medicine aided retinal imagingPatients 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 | Tele-medicine |
| Conventional referralAll eligible patients in the conventional arm will be counselled on the importance of eye screening and will be referred to the eye hospital | Other | Conventional Referral |
Primary outcome
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.
3 secondary outcomes
The severity of diabetic retinopathy (DR)
Time frame: 6 months
The acceptance rate for referral in each arm
Time frame: 6 months
Proportion of patients eligible for referral who had DR and who did not attend
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2015.
- Derived from this study: PubMed 31070699Joseph 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sanil Joseph, MHA, MSc principal investigator
Lions Aravind Institute of Community Ophthalmology, Aravind Eye Hospital, Madurai, India
Ramasamy Kim, DO, DNB study chair
Aravind Eye Hospital, Madruai, India
Thulasiraj Ravilla, MBA study chair
Lions Aravind Institute of Community Ophthalmology, Aravind Eye Hospital, Madurai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tele-medicine and Conventional referral in people with Diabetic Retinopathy, run by Aravind Eye Care System at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with confirmed Diabetic Retinopathy (DR) diagnosed at the eye hospital (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02085681, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2015.