| CTRI Number |
CTRI/2024/12/078294 [Registered on: 18/12/2024] Trial Registered Prospectively |
| Last Modified On: |
02/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Comparison of AI based disc photography with clinical assessment of optic disc cupping. |
|
Scientific Title of Study
|
Comparison of Artificial Intelligence based disc photography with clinical assessment of optic disc cupping |
| 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 Annu Joon |
| Designation |
Assistant Professor |
| Affiliation |
Guru Nanak Eye Centre |
| Address |
Director office room 55 Guru Nanak Eye Centre Maharaja Ranjeet Singh Marg LNJP Colony New Delhi
New Delhi
DELHI
110002
India |
| Phone |
01123234622 |
| Fax |
|
| Email |
annujoon@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rahul |
| Designation |
Post Graduate Student |
| Affiliation |
Guru Nanak Eye Centre |
| Address |
Director office room 55 Guru Nanak Eye Centre Maharaja Ranjeet Singh Marg LNJP Colony New Delhi
New Delhi
DELHI
110002
India |
| Phone |
9205561983 |
| Fax |
|
| Email |
rahul.ophtha@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rahul |
| Designation |
Post Graduate Student |
| Affiliation |
Guru Nanak Eye Centre |
| Address |
Director office room 55 Guru Nanak Eye Centre Maharaja Ranjeet Singh Marg LNJP Colony New Delhi
New Delhi
DELHI
110002
India |
| Phone |
9205561983 |
| Fax |
|
| Email |
rahul.ophtha@gmail.com |
|
|
Source of Monetary or Material Support
|
| Guru Nanak Eye Centre,Maharaja Ranjit Singh Road, Asaf Ali Road, Delhi - 110002 , India |
|
|
Primary Sponsor
|
| Name |
Guru Nanak Eye Centre |
| Address |
Guru Nanak Eye Centre,Maharaja Ranjit Singh Road, Asaf Ali Road, Delhi - 110002 , India |
| Type of Sponsor |
Government medical college |
|
|
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 ANNU JOON |
Guru Nanak Eye Centre |
Maharaja Ranjit Singh Marg, New Delhi
New Delhi
DELHI |
23234622
annujoon@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: H400||Glaucoma suspect, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Glaucoma suspects / glaucoma patients of age 18 years and above |
|
| ExclusionCriteria |
| Details |
1. Acute or sudden vision loss
2. Narrow angle pre-PI cannot be dilated safely
3. Coexisting ocular pathology (uveitis, keratitis, retinal detachment, other optic neuropathy)
4. Any media opacity
5. Recent ocular surgery within 1 month
6. Poor fixation |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| To observe the correlation and agreement between vertical cup-to-disc ratio assessed by an artificial intelligence software on disc photographs captured by fundus-on-phone camera, with clinical grading by an expert using Volk 78D slit lamp biomicroscopy. |
at time of presentation in glaucoma clinic |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the efficacy of artificial intelligence in detecting referable glaucoma |
at time of presentation in glaucoma clinic |
|
|
Target Sample Size
|
Total Sample Size="402"
Sample Size from India="402"
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)
|
01/01/2025 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
To observe the correlation and agreement between vertical cup-to-disc ratio assessed by an artificial
intelligence software on disc photographs captured by fundus-on-phone camera, with clinical grading by
an expert using Volk 78D slit lamp biomicroscopy.
|