| CTRI Number |
CTRI/2022/08/044578 [Registered on: 02/08/2022] Trial Registered Prospectively |
| Last Modified On: |
01/08/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Comparison of blood vessel changes in healthy and low vision eyes with the help of Optical coherence tomography angiography |
|
Scientific Title of Study
|
Comparison of retinal microvasculature in healthy and amblyopic children using Optical coherence tomography angiography |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Tisha Thomas Menacherry |
| Designation |
Opthalmology post graduate resident |
| Affiliation |
Sankara Eye Hospital |
| Address |
Sankara eye hospital
Sarvanampatti
Coimbatore
Coimbatore
TAMIL NADU
641035
India |
| Phone |
8281829912 |
| Fax |
|
| Email |
daphtish1996@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Rajesh Prabhu |
| Designation |
Pediatric Opthalmology Consultant |
| Affiliation |
Sankara Eye Hospital |
| Address |
Sankara eye hospital
Sarvanampatti
Coimbatore
Sankara Eye Hospital
Sarvanmpatti
Coimbatore
Coimbatore
TAMIL NADU
641035
India |
| Phone |
9442522373 |
| Fax |
|
| Email |
drrajeshprabu@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Tisha Thomas Menacherry |
| Designation |
Opthalmology post graduate resident |
| Affiliation |
Sankara Eye Hospital |
| Address |
Sankara eye hospital
Sarvanampatti
Coimbatore
Coimbatore
TAMIL NADU
641035
India |
| Phone |
8281829912 |
| Fax |
|
| Email |
daphtish1996@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sankara Eye Hospital , Coimbatore |
|
|
Primary Sponsor
|
| Name |
Tisha Thomas Menacherry |
| Address |
Sankara Eye Hospital
Saravanampatti |
| 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 |
| Tisha Thomas Menacherry |
Sankara Eye Hospital |
Pediatric Opthalmology department
Room no 5
16-A Sathy road, Ganapathy, Sivanandhapuram,TAMUL NADU
641035
Coimbatore
TAMIL NADU |
8281829912
daphtish1996@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,Sankara Eye Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H545||Low vision, one eye, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
Children aged 5 to 15 years newly diagnosed with anisometropic amblyopia
|
|
| ExclusionCriteria |
| Details |
Children less than 5 years and more than15 years
Children who are previously on treatment for anisometropic amblyopia.
Presence of strabismus, deprivation amblyopia, nystagmus
History of previous ocular surgery, intraocular inflammation, corneal disease, retinal disease or optic nerve disease
Ocular media opacities including cataract
Other diseases of the visual pathway
Glaucoma, neurological disease
Insufficient cooperation
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Relationship between retinal microvasculature and anisometropic amblyopia |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Any changes in retinal microcirculation compared to amblyopic eye and normal eye at the end of 1 year of study |
1 year |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
13/08/2022 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Anisometropic
amblyopia is the second leading cause of
amblyopia in children with strabismic amblyopia being first. Several studies
have been reported stating anatomical and functional changes in the visual
cortex and LGB(lateral geniculate body) nucleus in patients with amblyopia. But
involvement of retina in development of amblyopia is still a matter of debate, Though there are many studies recently
about the optic nerve head morphology, choroidal thickness ,there is very less study on
the retinal vasculature in amblyopic patients.Evaluation of the vascular system of the retina is also
of interest in terms of potential clinical and prognostic value of vascular
parameters in patients with macular diseases.
With the advent of OCTA (Optic Coherence Tomography Angiography) , a new and non invasive imaging modality,it permits visualisation of the microvasculature of the retina
throughout its depth , allowing for the identification of superficial and deep retinal capillary
plexus.
Although macular findings by OCTA in
patients with ambylopia have been extensively studied, most
of these focussed on foveal
thickness and retinal layer abnormalities.
This study is designed to investigate
potential changes in retinal microcirculation in children with anisometropic amblyopia when compared to healthy
eyes. |