FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2023/08/056388 [Registered on: 10/08/2023] Trial Registered Prospectively
Last Modified On: 01/08/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Single Arm Study 
Public Title of Study   Vascular changes seen on retinal imagining test (optical coherence tomography angiography) before and after occlusion therapy in amblyopia.  
Scientific Title of Study   Retinal microvascular parameters by optical coherence tomography angiography before and after amblyopia therapy in children. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Meghna Sethi 
Designation  Post Graduate Resident 
Affiliation  Maulana Azad Medical College 
Address  Room no. 219, Second floor, OPD block, Guru Nanak Eye Centre, New Delhi

Central
DELHI
110002
India 
Phone  9560601175  
Fax    
Email  meghnasethi25@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. Anju Rastogi 
Designation  Director Professor 
Affiliation  Maulana Azad Medical College 
Address  Room no. 219, Second floor, OPD block, Guru Nanak Eye Centre, New Delhi

Central
DELHI
110002
India 
Phone    
Fax    
Email  dranjurastogi@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Meghna Sethi 
Designation  Post Graduate Resident 
Affiliation  Maulana Azad Medical College 
Address  Room no. 219, Second floor, OPD Block, Guru Nanak Eye Centre, New Delhi

Central
DELHI
110002
India 
Phone  9560601175  
Fax    
Email  meghnasethi25@gmail.com  
 
Source of Monetary or Material Support  
Guru Nanak Eye Centre, Maharaja Ranjeet Singh Marg, LNJP Colony, New Delhi-110002 
 
Primary Sponsor  
Name  Maulana Azad Medical College and Associated Hospitals 
Address  2, Bahadur Shah Zafar Marg, near Delhi Gate, Maulana Azad Medical College Campus, Balmiki Basti, New Delhi, Delhi 110002 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Meghna Sethi  Guru Nanak Eye Centre  Department of Ophthalmology, Guru Nanak Eye Centre, Maharaja Ranjeet Singh Marg, LNJP Colony, New Delhi-110002
Central
DELHI 		 9560601175

meghnasethi25@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Maulana Azad Medical College  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H53||Visual disturbances,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NA  NA 
Intervention  Occlusion therapy for unilateral amblyopia.  Occlusion therapy for patients aged 4-12 years with unilateral amblyopia and comparison of retinal microvascular changes before and after 3 months of the occlusion therapy. 
 
Inclusion Criteria  
Age From  4.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  1.Patients aged 4-12 years.
2.Patients with strabismic / anisometropic /sensory deprivation amblyopia.
3.Pseudophakic patients with clear visual axis
 
 
ExclusionCriteria 
Details  1.Bilateral amblyopia
2.Ametropic amblyopia
3.Poor quality OCT-A scans
4.Poor fixation/ nystagmus/ uncooperative children
5.Children with spherical refractive errors of +/-5.00 diopters(D) or cylindrical refractive errors of 3.00 diopters(D) or greater.
6.Ocular diseases viz. corneal opacities, uveitis, retinal pathology.
7.History of prematurity.
8.History of neurological disease.
9.History of any systemic condition that could alter the retinal microvasculature (juvenile onset diabetes, renal disease, hypertension).
10.History of skin allergies and irritations with bandage-type occluders. 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
T0 assess the retinal microvasculature in pre-treatment & post-treatment amblyopic eyes using following parameters in OCTA [Model: RS-3000 LITE advanced (NIDEK)]:
•Foveal Avascular Zone Measurements (FAZ) (mm2)
•Macular Vessel density percentage of SCP scan
•Macular Vessel density percentage of DCP scan 		 3 MONTHS 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the following parameters in pre-treatment & post-treatment amblyopic eyes using OCT (Model: REVO 60 Optipol)
•Central Macular thickness (µm)
•Peripapillary Retinal nerve fiber layer thickness (µm) 		 3 MONTHS 
 
Target Sample Size   Total Sample Size="15"
Sample Size from India="15" 
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)   14/08/2023 
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 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   WE WILL BE EVALUATING THE MICROVASCULAR PARAMETERS BEFORE AND AFTER AMBLYOPIA PATCHING THERAPY IN CHILDREN AGED 4 TO 12 YEARS ATTENDING THE PEDIATRIC OPHTHALMOLOGY CLINIC (POC) AT GURU NANAK EYE CENTRE. A TOTAL OF 15 CHILDREN WITH UNILATERAL AMBLYOPIA WILL BE RECRUITED WHO WILL BE GIVEN PATCHING THERAPY ACCORDING TO THEIR AGES AND MICROVASCULAR PARAMETERS WILL BE RECORDED AND COMPARED BEFORE AND AFTER THE THERAPY THROUGH OPITICAL COHERENCE TOMOGRAPHY ANGIOGRAPHY(OCTA). 
Close