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CTRI Number  CTRI/2024/11/076417 [Registered on: 08/11/2024] Trial Registered Prospectively
Last Modified On: 10/04/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Medical Device
Diagnostic 
Study Design  Other 
Public Title of Study   AI for screening retinal diseases 
Scientific Title of Study   Performance of a Generic Artificial Intelligence algorithm on a smartphone fundus camera for screening retinal conditions  
Trial Acronym  Not applicable 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Manavi D Sindal 
Designation  HOD Retina and Vitreous Services 
Affiliation  Aravind Eye Hospital 
Address  Room No 22 B Block First floor Retina clinic
Aravind Eye Hospital Cuddalore main road Thavalakuppam
Pondicherry
PONDICHERRY
605007
India 
Phone  9884081417  
Fax  0413-2618848  
Email  manavi@aravind.org  
 
Details of Contact Person
Scientific Query
 
Name  Dr Manavi D Sindal 
Designation  HOD Retina and Vitreous Services 
Affiliation  Aravind Eye Hospital 
Address  Room No 22 B block First floor Retina clinic
Aravind Eye Hospital Cuddalore main road Thavalakuppam
Pondicherry
PONDICHERRY
605007
India 
Phone  9884081417  
Fax  0413-2618848  
Email  manavi@aravind.org  
 
Details of Contact Person
Public Query
 
Name  Dr Manavi D Sindal 
Designation  HOD Retina and Vitreous Services 
Affiliation  Aravind Eye Hospital 
Address  Room No 22 B Block First floor Retina Clinic
Aravind Eye Hospital Cuddalore main road Thavalakuppam
Pondicherry
PONDICHERRY
605007
India 
Phone  9884081417  
Fax  0413-2618848  
Email  manavi@aravind.org  
 
Source of Monetary or Material Support  
Remidio Innovative Solutions Pvt Ltd Bengaluru 
 
Primary Sponsor  
Name  Remidio Innovative Solutions Inc 
Address  No 1-51-2/12 Vacuum Techniques Compound 1st Cross Rd Phase-I Peenya Bengaluru Karnataka 560058 
Type of Sponsor  Other [Device Manufacturer] 
 
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 Manavi D Sindal  Aravind Eye Hospital  Room No 5 and 6 Ground floor B Block Aravind Eye Hospital Cuddalore main road Thavalakuppam
Pondicherry
PONDICHERRY 
9884081417
0413-2618848
manavi@aravind.org 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Aravind Eye Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H36||Retinal disorders in diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NA  NA 
Comparator Agent  NA  NA 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Consecutive patients above 40 years of age in the general ophthalmology clinic with known or unknown retinal conditions or glaucoma  
 
ExclusionCriteria 
Details  1.Significant media opacities (cataract worse than NO4/NC4/P3 or C3 – LOCS III scale) or other conditions precluding adequate view of the macula or disc for fundus imaging (insufficient image quality) and active infections.
2. Undergone any retinal surgery, lasers, intravitreal injections
3.Hypersensitive to light
4.Presence of any neurological conditions
5.Contraindication to dilation & without definitive diagnosis
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To evaluate the performance of a generic artificial intelligence algorithm that can screen for retinal conditions/glaucoma against two reference standard (a) Ophthalmologist (specialist) diagnosis based on a comprehensive eye examination and (b) consensus image grading by two blinded specialists (adjudicated by a senior specialist).  6 Months 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="545"
Sample Size from India="545" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   N/A 
Date of First Enrollment (India)   02/12/2024 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

 

Age-Related Macular Degeneration (AMD), Diabetic Retinopathy (DR), and Glaucoma represent formidable challenges in the field of ophthalmology, collectively constituting leading retinal causes of vision impairment and blindness globally1. Early identification of pathological changes allows for the implementation of targeted interventions, ranging from lifestyle modifications and pharmacological treatments to surgical procedures. In ophthalmology, AI has emerged as a promising ally, offering the potential to revolutionize the diagnosis and management of ocular diseases, including AMD, DR, Glaucoma, ROP, and cataract2-4

 

  The Medios AI, developed by Medios Technologies, Remidio Innovative Solutions in Singapore, has designed algorithms to screen referable forms of DR, AMD, and Glaucoma. This AI system has undergone extensive validation upon integration with Remidio’s non-mydriatic smartphone-based fundus camera, known as Fundus on phone (FOP). Combining and developing a unified AI algorithm (Generic AI) capable of screening for various referable retinal conditions would offer significant advantages

 

  This prospective study will be conducted at the general outpatient department of AEH, Pondicherry. Every consecutive patient that consents to participate will sign a written informed consent form. Following a comprehensive eye examination, fundus imaging using the study device will be captured in all the participants and the generic AI algorithm will be run on the images captured. 

 

Methodology

All the participants will undergo a comprehensive eye examination as a part of routine eye care at the hospital. The medical record information including demographic details, best-corrected visual acuity, anterior and posterior segment examination details, goniosocopy (if Van-Herick grading 2 or less than grade 2), IOP, and other investigations (if any) conducted for final diagnosis of retinal conditions will be recorded.

The final diagnosis by the retina/glaucoma specialist along with the severity staging of the respective retinal or optic disc abnormality (if any) will be documented.

Patients evaluated in general clinic and noted to have a retinal pathology/glaucoma by examining doctor or flagged as referrable by AI will be referred to respective clinic. These patients will be evaluated by a consultant in the specialty clinic to ensure accuracy of clinical diagnosis. All the fundus images captured using reference standard fundus camera will be uploaded to a grading platform. Two specialists (one retina and one glaucoma) masked to clinical information and each other’s findings will grade (a) quality of images (disc and macula centered) captured, (b) grading of fundus images that are presented randomly.

 
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