| 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
|
|
|
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
|
|
|
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. |