| CTRI Number |
CTRI/2024/07/071446 [Registered on: 26/07/2024] Trial Registered Prospectively |
| Last Modified On: |
26/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Diagnostic
Screening |
| Study Design |
Other |
|
Public Title of Study
|
To create a device to checked if the patient has amblyopia or not without their response |
|
Scientific Title of Study
|
Development of a Device to Objectively Assess the Size and
Depth of Suppression |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
DCGI |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sebin C Sebastian |
| Designation |
Optometry faculty |
| Affiliation |
Sankara eye hospital |
| Address |
Sankara eye hospital Ludhiana, department of vision therapy room no.15
Sankara eye hospital Ludhiana, department of vision therapy room no.15
Ludhiana
PUNJAB
141101
India |
| Phone |
9900943509 |
| Fax |
|
| Email |
sebinsebastian2014@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Mohammad Nooruz Zaman |
| Designation |
Optometry faculty |
| Affiliation |
Sankara eye hospital |
| Address |
Sankara eye hospital, Ludhiana Punjab
Division: Optometry
Department: Vision Therapy
Room No.15
Sankara eye hospital Sankara eye hospital, Ludhiana Punjab
Division: Optometry
Department: Vision Therapy
Room No.15
Ludhiana
PUNJAB
141101
India |
| Phone |
9900943509 |
| Fax |
|
| Email |
mohammadnoor92@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sebin C Sebastian |
| Designation |
Optometry faculty |
| Affiliation |
Sankara eye hospital |
| Address |
Sankara eye hospital Ludhiana, department of vision therapy room no.15
Sankara eye hospital Ludhiana, department of vision therapy room no.15
PUNJAB
141101
India |
| Phone |
9900943509 |
| Fax |
|
| Email |
sebinsebastian2014@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sankara Eye Hospital, Ludhiana Punjab, Pin code 141101 |
|
|
Primary Sponsor
|
| Name |
nil |
| Address |
no sponsor |
| Type of Sponsor |
Other [] |
|
|
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 |
| DrSebin |
Sankara eye hospital PUNJAB |
Sankara Eye Hospital Punjab Department of vision therapy, room no 15
Ludhiana
PUNJAB |
9900943509
sebinsebastian2014@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SANKARA EYE HOSPITAL SRI KANCHI KAMAKOTI MEDICAL TRUST INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Normal Volunteers |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
AMBLYOPIA |
To make a device to asses size and depth of suppression objectively
Trail duration: 2months
|
| Intervention |
To make a device to asses size and depth of suppression objectively |
To make a device to asses size and depth of suppression objectively
Time duration 2 months |
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Subjects who have refractive amblyopia |
|
| ExclusionCriteria |
| Details |
Subjects who have strabismus
Suppression is absent
Age group less than 10 years |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Objectively Assess the Size of Suppression |
Objectively Assess the Size of Suppression At baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Objectively Assess the Depth of Suppression |
Objectively Assess the Depth of Suppression
AT Baseline |
|
|
Target Sample Size
|
Total Sample Size="69"
Sample Size from India="69"
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)
|
18/09/2024 |
| 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="0"
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
|
1) Approval from institutional scientific and ethics committee 2) Consent is to be signed by the participants 3) Baseline evaluation: History, Visual acuity & Refraction, Slit lamp evaluation, Fundus, W4DT, Neutral density filter 4)Suppression 5) Comparing the size of the suppression with the developed device and W4DT 6)Comparing the depth of suppression with the developed device and Neutral density filter |