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CTRI Number  CTRI/2022/11/047093 [Registered on: 07/11/2022] Trial Registered Prospectively
Last Modified On: 20/10/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Screening
Process of Care Changes 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   A study to evaluate the impact of a software to detect eye diseases (Google-ARDA) among people with type 2 diabetes in India. 
Scientific Title of Study   Effectiveness of Google-Automated Retinal Disease Assessment (ARDA) tool assisted diabetic retinopathy screening program among people with type 2 diabetes in India-A three arm Randomized Controlled Trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Nikhil Tandon  
Designation  Professor and Head  
Affiliation  All India Institute of Medical Sciences, New Delhi  
Address  Department of Endocrinology and metabolism, 3rd Floor, Biotechnology block, All India Institute of Medical Sciences, New Delhi

South
DELHI
110029
India 
Phone    
Fax    
Email  nikhil_tandon@hotmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Nikhil Tandon  
Designation  Professor and Head  
Affiliation  All India Institute of Medical Sciences, New Delhi  
Address  Department of Endocrinology and metabolism, 3rd Floor, Biotechnology block, All India Institute of Medical Sciences, New Delhi

South
DELHI
110029
India 
Phone    
Fax    
Email  nikhil_tandon@hotmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Nikhil Tandon  
Designation  Professor and Head  
Affiliation  All India Institute of Medical Sciences, New Delhi  
Address  Department of Endocrinology and metabolism, 3rd Floor, Biotechnology block, All India Institute of Medical Sciences, New Delhi

South
DELHI
110029
India 
Phone    
Fax    
Email  nikhil_tandon@hotmail.com  
 
Source of Monetary or Material Support  
Google LLC  
 
Primary Sponsor  
Name  Google LLC  
Address  1600 Amphitheatre Parkway Mountain View, California 94043, USA  
Type of Sponsor  Other [Technology company-Global ] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Nikhil Tandon   All India Institute of Medical Sciences, New Delhi   Department of Endocrinology and Metabolism, Room Number-308, Third floor, Biotechnology block, AIIMS, Ansari Nagar, New Delhi
South
DELHI 		 011-26593433

nikhil_tandon@hotmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, All India Institute of Medical Sciences   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E113||Type 2 diabetes mellitus with ophthalmic complications,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Automated Retinal Disease Assessment (ARDA) tool assisted diabetic retinopathy screening   Participants get their fundus photos taken by a camera technician. One image (primary field of view) per eye will be taken using a fundus camera. The technician will then upload the images to ARDA for diagnosis. ARDA will return Diabetic Retinopathy grades for each eye. The technician will note the grades in the chart for the diabetes specialist to review. If ARDA comes back with a referable grade (presence of any Diabetic Retinopathy), the diabetes specialist will refer the participant and the technician will arrange an appointment at the ophthalmology department for treatment and follow up. If ARDA comes back as non-referable (No Diabetic Retinopathy), then the diabetes specialist will inform the participant about the grades and encourage him/her for annual eye screening in the next year.  
Comparator Agent  Enhanced standard of care arm  Participant gets their fundus photos taken by a camera technician. The technician uploads the images/transfer images manually to the retina specialist. Retina specialist grades the images and the results will be communicated to the diabetes specialist with an appointment date. The technician will inform the Diabetic Retinopathy positive participants telephonically and share the appointment date to visit the ophthalmology department for care and follow up  
Comparator Agent  Standard care arm  All the consented participants, randomized to this arm are referred to the ophthalmology department of annual retinopathy screening 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  89.00 Year(s)
Gender  Both 
Details  With at least 3 years of diabetes duration from the date of diagnosis and
Resident of Delhi-NCR and
Willing/able to give consent to participate in the study
 
 
ExclusionCriteria 
Details  Participants who fall under any of the following criteria will be excluded:
Previous diagnosis of any Diabetic Retinopathy (DR)
Participants with any visual symptoms or conditions (e.g., loss of vision, blurry vision, persistent floaters), other than those corrected with glasses, contact lenses or other refractive corrections
Undergone any laser treatment of the retina in the past
Undergone any retinal surgeries
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Proportion of participants who had at least one visit at ophthalmology facility (for DR screening/follow up) within three months from the date of referral  Three months from the date of referral  
 
Secondary Outcome  
Outcome  TimePoints 
Time taken to adhere with referrals to eye specialist (i.e., number of days it took for participants to see ophthalmologists from the date of referral)
Measure the impact of enhanced standard care and ARDA on reducing the time between DR screening and start of ophthalmic management of a referable condition
Proportion of referred participant, who had received any treatment from ophthalmology facility at three months from the date of referral
Participant satisfaction with DR screening and referral (at three months)
 		 Three months from the date of referral 
 
Target Sample Size   Total Sample Size="1125"
Sample Size from India="1125" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3/ Phase 4 
Date of First Enrollment (India)   01/12/2022 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Not Applicable  
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

It is evident from the current literature that regular diabetic retinopathy (DR) screening and early treatment can prevent DR-associated vision loss. However, some DR screening programs within tertiary care settings have found low rates of patient adherence to referral recommendations, even following a positive screen for vision-threatening DR . The authors hypothesized that adherence can be increased by providing screening results immediately and improving workflows by engaging patients and, when needed, scheduling a follow-up ophthalmology appointment immediately.

The objectives of the current study are;

 To test the effectiveness of Google-ARDA assisted program for screening for diabetic retinopathy (DR) among people with type 2 diabetes compared to;

1a. Standard care (referral to ophthalmology to get a retinal fundus evaluation) and

1b. Enhanced standard care (fundus images are taken at the diabetes care facility and are sent to the retina specialist for screening)

The primary outcome of the trial is the  difference in proportion of participants who had at least one visit at ophthalmology facility (for DR screening/follow up) within three months from the date of referral between the three arms.


 

 
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