| CTRI Number |
CTRI/2025/09/094968 [Registered on: 17/09/2025] Trial Registered Prospectively |
| Last Modified On: |
16/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Quantification of asymmetrical optic neuropathy |
|
Scientific Title of Study
|
Quantification of Relative Afferent Pupillary Defect by Automated Pupillometry |
| 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 Paromita Dutta |
| Designation |
Associate professor and head of unit |
| Affiliation |
Department of ophthalmology , G.N.E.C |
| Address |
Department of Ophthalmology Maulana Azad medical college, Guru Nanak eye center ,New delhi
Central
DELHI
110002
India |
| Phone |
9873319983 |
| Fax |
|
| Email |
mitad.4@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Namita Kedia |
| Designation |
PG Student |
| Affiliation |
Department of Ophthalmology , Maulana azad medical college, Guru Nanak eye center ,New delhi |
| Address |
Department of Ophthalmology, Maulana Azad medical college, Guru Nanak eye center ,New delhi
Central
DELHI
110002
India |
| Phone |
8295468098 |
| Fax |
|
| Email |
nkedia52@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Namita kedia |
| Designation |
Pg student |
| Affiliation |
Department of Ophthalmology,Maulana azad medical college, Guru Nanak eye center ,New delhi |
| Address |
Department of Ophthalmology,Maulana azad medical college, Guru Nanak eye center ,New delhi
Central
DELHI
110002
India |
| Phone |
8295468098 |
| Fax |
|
| Email |
nkedia52@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of ophthalmology Maulana azad medical college |
|
|
Primary Sponsor
|
| Name |
Maulana Azad Medical College and associated hospitals Guru Nanak Eye Centre |
| Address |
Maulana Azad Medical College and associated hospitals Guru Nanak Eye Centre New Delhi 110002 |
| 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 Namita Kedia |
Guru Nanak Eye Centre |
Room no 101 department of ophthalmology
Central
DELHI |
8295468098
nkedia52@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Maulana Azad Medical college institutional committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H472||Optic atrophy, |
|
|
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 |
Clinically diagnosed unilateral asymmetrical optic neuropathy |
|
| ExclusionCriteria |
| Details |
1) any iris or pupil abnormalities
2) acute optic nerve head swelling
3) history of ocular trauma
4) diabetics
5) patients on topical mydriatic or miotics
6) patients talking alpha adrenergic or narcotics
7) patients with hazy media
8) nystagmus or poor fixation
9) previous intraocular surgery |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Quantification of pupillometer derived Relative afferent pupillary defect scores for detecting RAPD |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) Association of RAPD score with differences in latency of pattern visual evoked potential
2) Association of RAPD score with differences in retinal nerve fibre layer thickness |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
29/09/2025 |
| 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 observational cross sectional study aims at quantification of relative afferent pupillary defect by automated pupillometry in patients with optic neuropathy. It would be conducted at Guru Nanak eye centre. The primary outcome is area under receiver operating characteristic curve of pupillometer derived relative afferent pupillary defect score for detecting RAPD. |