| CTRI Number |
CTRI/2025/12/099076 [Registered on: 15/12/2025] Trial Registered Prospectively |
| Last Modified On: |
12/12/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Detection of glaucoma using an artificial intelligence tool which is incorporated into 3 fundus cameras |
|
Scientific Title of Study
|
Prospective Clinical Trial of an AI tool for Glaucoma Detection using 3 Fundus cameras |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Salwa Kaidakath |
| Designation |
Fellow in Glaucoma |
| Affiliation |
Sankara Eye Hospital |
| Address |
Room 27, Glaucoma department,
Sankara Eye Hospital
Varthur Road
Marathahalli
Bangalore
Bangalore
KARNATAKA
560037
India |
| Phone |
7639958681 |
| Fax |
|
| Email |
sksalwaibrahim@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Meena Gopinath Menon |
| Designation |
Head of the Deparrtment, Glaucoma |
| Affiliation |
Sankara Eye Hospital |
| Address |
Room 27, Glaucoma Department,
Sankara Eye Hospital
Varthur Road
Marathahalli
Bangalore
Bangalore
KARNATAKA
560037
India |
| Phone |
9886283310 |
| Fax |
|
| Email |
meenagm@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Salwa Kaidakath |
| Designation |
Fellow in Glaucoma |
| Affiliation |
Sankara Eye Hospital |
| Address |
Room 27, Glaucoma Department,
Sankara Eye Hospital
Varthur Road
Marathahalli
Bangalore
Bangalore
KARNATAKA
560037
India |
| Phone |
7639958681 |
| Fax |
|
| Email |
sksalwaibrahim@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Sankara Eye Hospital Bangalore |
| Address |
Sankara Eye Hospital,
Varthur Road,
Bangalore,
India
560037 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Salwa Kaidakath |
Sankara Eye Hospital, Bangalore |
Room 27, Glaucoma department,
Sankara Eye Hospital,
Varthur Road,
Bangalore,
India
560037
Bangalore
KARNATAKA |
7639958681
sksalwaibrahim@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H00-H59||Diseases of the eye and adnexa, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Ability and willingness to provide informed consent, patients attending OPD for routine eye checkup or glaucoma screening and evaluation |
|
| ExclusionCriteria |
| Details |
Any condition affecting media clarity (corneal opacity, mature cataract, etc)
History of glaucoma surgery/ cataract surgery done in last 3 months |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Agreement between AI and image-based grading by specialists
2. Diagnostic accuracy of the AI system vs. gold standard (specialist diagnosis):
Sensitivity,Specificity,Accuracy
|
At baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Repeatability of AI output (subset of eyes imaged twice) |
At baseline |
|
|
Target Sample Size
|
Total Sample Size="246"
Sample Size from India="246"
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)
|
01/01/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
01/01/2026 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Our study is a prospective clinical trial of an AI tool in detection of glaucoma using 3 fundus cameras. Primary objective is to evaluate the diagnostic accuracy of the AI detection tool against the gold standard clinical evaluationa and against the glaucoma specialist grading. The significance of the study is that it improves the screening efficiency in outreach areas. |