| CTRI Number |
CTRI/2025/10/095657 [Registered on: 06/10/2025] Trial Registered Prospectively |
| Last Modified On: |
18/12/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Improving Eye Care: A Study on AI-Based vs. Manual Screening of Eye Images |
|
Scientific Title of Study
|
Automated vs. Manual Screening of Eye Images: A Comparative Study of Artificial Intelligence-Based Diabetic Retinopathy Detection |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Uday Gajiwala |
| Designation |
Superintendent |
| Affiliation |
Divyajyoti Trust |
| Address |
Divyajyoti Trust AT and Post Amalsadi Ta Mandvi Dist. Surat Gujarat
Divyajyoti Trust AT and Post Amalsadi Ta Mandvi Dist. Surat Gujarat
Surat
GUJARAT
394163
India |
| Phone |
02623221180 |
| Fax |
|
| Email |
divyajyoti.icare@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Uday Gajiwala |
| Designation |
Superintendent |
| Affiliation |
Divyajyoti Trust |
| Address |
Divyajyoti Trust AT and Post Amalsadi Ta Mandvi Dist. Surat Gujarat
Divyajyoti Trust AT and Post Amalsadi Ta Mandvi Dist. Surat Gujarat
GUJARAT
394163
India |
| Phone |
02623221180 |
| Fax |
|
| Email |
divyajyoti.icare@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Uday Gajiwala |
| Designation |
Superintendent |
| Affiliation |
Divyajyoti Trust |
| Address |
Divyajyoti Trust AT and Post Amalsadi Ta Mandvi Dist. Surat Gujarat
Divyajyoti Trust AT and Post Amalsadi Ta Mandvi Dist. Surat Gujarat
GUJARAT
394163
India |
| Phone |
02623221180 |
| Fax |
|
| Email |
divyajyoti.icare@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Divyajyoti Trust |
| Address |
Divyajyoti Trust AT and Post Amalsadi Ta Mandvi Dist. Surat Gujarat |
| Type of Sponsor |
Other [NGO] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Divyajyoti trust |
Divyajyoti Trust AT and Post Amalsadi Ta Mandvi Dist. Surat Gujarat |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Uday Gajiwala |
Divyajyoti Trust |
Divyajyoti Trust AT and Post Amalsadi Ta Mandvi Dist. Surat Gujarat
Divyajyoti Trust AT and Post Amalsadi Ta Mandvi Dist. Surat Gujarat
Surat
GUJARAT |
02623221180
divyajyoti.icare@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC Divyajyoti Trust Tejas Eye Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H356||Retinal hemorrhage, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
All patients above the age of 40 years residing in Umarpada taluka
|
|
| ExclusionCriteria |
| Details |
Media opacity
Patient denies examination
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
The primary outcome of the study appears to be a comparison of the rapidity, quality, and cost of screening fundus photography using two different modalities:
1. AI-based imaging tool
2. Manual grading by a grader
|
Time PointsThe study will assess these outcomes at specific time points:
1. Baseline: Initial assessment
2. 4 weeks: Follow-up assessment
3. 8 weeks: Final assessment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Diagnostic Accuracy: Comparison of true positives, false positives, true negatives, & false negatives between AI-based imaging tool & manual grading.
2. Grader Agreement: Inter-grader reliability & agreement between AI-based tool & manual grading.
3. Image Quality Assessment: Evaluation of image quality & its impact on grading accuracy.
4. User Experience: Feedback from graders & users on the usability & satisfaction with AI-based tool vs. manual grading.
5. Error Rates: Comparison of error rates, such as false negatives or false positives, between the two modalities.
|
These secondary outcomes can be assessed at the same time points as the primary outcome:
1. Baseline: Initial assessment
2. 4 weeks: Follow-up assessment
3. 8 weeks: Final assessment |
|
|
Target Sample Size
|
Total Sample Size="15000"
Sample Size from India="15000"
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
|
N/A |
|
Date of First Enrollment (India)
|
20/10/2025 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
This is only an observational study. There is no intervention taking place
Hence,
safety is not a concern at all |