| CTRI Number |
CTRI/2021/11/038090 [Registered on: 17/11/2021] Trial Registered Prospectively |
| Last Modified On: |
17/11/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Vascular changes in retina in amblyopic eyes verse in healthy eyes |
|
Scientific Title of Study
|
Microvascular Changes In Amblyopic Eyes Versus Healthy Eyes By Optical Coherence Tomography Angiography In Children |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR Anju Rastogi |
| Designation |
Director Professor |
| Affiliation |
Guru Nanak Eye Center |
| Address |
Room 102 first floor Opd Building Guru Nanak Eye Center
Maharaja Ranjeet Singh Marg New Delhi
New Delhi
DELHI
110002
India |
| Phone |
|
| Fax |
|
| Email |
dranjurastogi@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Varsha Negi |
| Designation |
Post Graduate Resident |
| Affiliation |
Guru Nanak Eye Center |
| Address |
D14 second floor Feroz Shah Kotla Opposite to MaulanaAzad Maedical College
New Delhi
DELHI
110002
India |
| Phone |
|
| Fax |
|
| Email |
varshaengi96@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Varsha Negi |
| Designation |
Post Graduate Resident |
| Affiliation |
Guru Nanak Eye Center |
| Address |
D14 second floor Feroz Shah Kotla Opposite to MaulanaAzad Maedical College
New Delhi
DELHI
110002
India |
| Phone |
|
| Fax |
|
| Email |
varshanegi96@gmail.com |
|
|
Source of Monetary or Material Support
|
| Guru Nanak Eye Center,Maharaja Ranjeet Singh Marg,New Delhi 110002 |
|
|
Primary Sponsor
|
| Name |
Varsha Negi |
| Address |
Guru Nanak Eye Centre ,Maharaja Ranjeet Singh Marg |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Varsha Negi |
Guru Nanak eye Center |
Room No 102 OPD building (first floor)
New Delhi
DELHI |
9582012577
varshanegi96@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: H53-H54||Visual disturbances and blindness, (2) ICD-10 Condition: H53-H54||Visual disturbances and blindness, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients in the age group of 6 to18 years with strabismic and anisometropic amblyopia (difference of at least 2 lines in BCVA between 2 eyes)
2.Age and Gender matched patients referred to OPD for routine eye examination will be recruited as control eyes. |
|
| ExclusionCriteria |
| Details |
1.Poor quality scans and un co-operative child.
2.Children with spherical refractive errors of +/- 5.00 diopters(D) or greater and cylindrical refractive errors of 3.00 diopters(D) or greater.
3.Children with poor fixation, nystagmus, eccentric fixation.
4.Ocular diseases viz. cataract, corneal opacities, uveitis, retinal pathology
5.History of intraocular surgery
6.History of any systemic condition that could alter the retinal microvasculature
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Foveal Avascular Zone Measurements (mm square)
2.Macular Vessel density percentage of SCP scan
3.Macular Vessel density percentage of DCP scan
|
Baseline
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Central Macular thickness (µm)
2.Peripapillary Retinal nerve fiber layer thickness (µm)
|
1 year |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
20/11/2021 |
| 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
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The study will be conducted in children with amblyopia attending the outpatient
department and Paediatric Ophthalmology Clinic in Guru Nanak Eye Centre.A total of 60 eyes will be included in the study.They will be divided into three
groups (20 eyes in each group). Group1-
Amblyopic Eyes,Group
2- Fellow Eyes, Group
3- Control Eyes.The Study Time is one year.Using
OCTA (RS-3000 LITE advanced (NIDEK)
following parameters will be evaluated-1. Foveal Avascular Zone Measurements (mm2)2.
Macular Vessel density percentage of SCP scan
3.
Macular Vessel density percentage of DCP scan Using OCT(Revo 60 Optipol) following parameters will be evaluated-
1.Central
Macular Thickness (µm)
2. Peripapillary Retinal Nerve Fibre Layer
thickness(µm) |