| CTRI Number |
CTRI/2026/01/102627 [Registered on: 30/01/2026] Trial Registered Prospectively |
| Last Modified On: |
30/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Screening
Other (Specify) [Home Based Vision Therapy] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
School Screening Program for visual disorders and effect of home based vision therapy as management. |
|
Scientific Title of Study
|
Optometric Screening Program for Evaluating Visual Health Anomalies and Effectiveness of Home-Based Vision Therapy among Urban and Rural School 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 |
Reshma Ramakrishnan |
| Designation |
Professor, Department of Ophthalmology, MGM Medical College and Hospital, Kamothe, Navi Mumbai. |
| Affiliation |
MGM Institute of Health Sciences, Kamothe, Navi Mumbai. |
| Address |
Department of Ophthalmology, MGM Medical College and Hospital, Kamothe, Navi Mumbai. MGM Institute of Health Sciences, MGM Campus, Sector 1, Kamothe, Navi Mumbai-410209, MAHARASHTRA STATE (INDIA)
Raigarh
MAHARASHTRA
410209
India |
| Phone |
9930007490 |
| Fax |
|
| Email |
anandreshma@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Reshma Ramakrishnan |
| Designation |
Professor, Department of Ophthalmology, MGM Medical College and Hospital, Kamothe, Navi Mumbai. |
| Affiliation |
MGM Institute of Health Sciences, Kamothe, Navi Mumbai. |
| Address |
Department of Ophthalmology, MGM Medical College and Hospital, Kamothe, Navi Mumbai. MGM Institute of Health Sciences, MGM Campus, Sector 1, Kamothe, Navi Mumbai-410209, MAHARASHTRA STATE (INDIA)
Raigarh
MAHARASHTRA
410209
India |
| Phone |
9930007490 |
| Fax |
|
| Email |
anandreshma@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Soniya Salve |
| Designation |
PhD Scholar |
| Affiliation |
MGM School of Biomedical Sciences, MGM Institute of Health Sciences, Kamothe, Navi Mumbai. |
| Address |
Department of Optometry, MGM School of Biomedical Sciences, MGM Institute of Health Sciences, MGM Campus, Sector 1, Kamothe, Navi Mumbai-410209, MAHARASHTRA STATE (INDIA)
Raigarh
MAHARASHTRA
410209
India |
| Phone |
7021741970 |
| Fax |
|
| Email |
soniyasalve1999@gmail.com |
|
|
Source of Monetary or Material Support
|
| MGM Institute of Health Sciences, Kamothe, Navi Mumbai. |
|
|
Primary Sponsor
|
| Name |
Dr. Reshma Ramakrishnan |
| Address |
Department of Ophthalmology, MGM Medical College and Hospital, MGM Institute of Health Sciences
MGM Campus, Sector 1, Kamothe, Navi Mumbai-410209, MAHARASHTRA STATE (INDIA) |
| 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 |
| Dr Reshma Ramakrishnan |
MGM Medical College and Hospital, MGM IHS, Kamothe, Navi Mumbai. |
Department of Ophthalmology and Department of Optometry,
MGM Institute of Health Sciences, PLOT NUMBER 1 & 2 ,KALAMBOLI CIRCLE , MGM CAMPUS KAMOTHE , PANVEL MUNICIPAL CORPORATION ,KAMOTHE , PANVEL , Pincode:410206
Raigarh
MAHARASHTRA |
9930007490
anandreshma@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethical Committee of Research on Human Subjects of MGM Institute of Health Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Non Strabismic Binocular Vision Dysfunction (NSBVD) |
| Patients |
(1) ICD-10 Condition: H533||Other and unspecified disorders ofbinocular vision, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Home Based Vision Therapy |
Home Based Vision Therapy will be given 3 days a week with duration of 30 mins for 3 months as a management modality for visual discomfort |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
1. School children in the age group of (5th - 9th)
std 1O - 16 years.
2. School children of either gender.
3. School children with consent provided by parent’s
approval.
|
|
| ExclusionCriteria |
| Details |
1. School children with known neurological
disorder or systemic diseases (acute and
chronic) that impact vision.
2. School children with previously diagnosed
binocular vision disorders, or prior vision
therapy on treatment.
3. School children with active ocular infection
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Prevalence of visual health
anomalies among urban and
rural schools.
2. Comparison of visual health
anomalies among urban and
rural schools.
3. Effectiveness of
Home Based Vision Therapy
for Non Strabismic
Binocular Vision Disorder
(NSBVD).
4. Teacher’s
perspective about children
eye health among urban and
rural schools using
structured questionnaire.
5. Reading habits and digital
devices usage among urban
and rural school children
using structured
questionnaire.
|
12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Distribution of visual
health anomalies.
2. Distribution and pattern of
visual health anomalies
among urban and rural
school.
3. Changes in visual symptoms
after providing Home Based
Binocular Vision Therapy.
4. Association of Teacher’s
perspective about children
eye health among urban and
rural schools using
structured questionnaire.
5. Association of Reading
habits and digital
devices usage among urban
and rural school children
using structured
questionnaire.
|
12 weeks |
|
|
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)
|
01/03/2026 |
| 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="9"
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
|
A rise in non-strabismic accommodative and
vergence dysfunctions has been
noticed. The core element of child’s educational experience is the ability
to learn through reading. This learning process involves both accommodative and vergence mechanisms, and an imbalance in sensory-motor integration can lead to non-strabismic accommodative and/or binocular
vision disorders (NSBVD). Therefore, any abnormalities in the visual
system can adversely affect children’s cognitive
development and their educational
progress. It is commonly seen in school-aged children, particularly high school
students who have greater demands on their accommodative and vergence systems. A significant number of Ocular anomalies are
treatable and often preventable. Globally the prevalence of Uncorrected Refractive error, Strabismus, Amblyopia, Anterior and Posterior segment abnormality has been
seen increasing hampering their overall development and social life. While diminished visual clarity may be
identified during school eye examinations, general binocular dysfunctions,
including near vision blurriness, headaches, eye strain, difficulties in
comprehension and concentration, or the tendency to reread the same line, are
more challenging to detect. Pediatric vision screening aims at identifying
potential visual risk factors that could hinder the growth and development of the eye and visual
system in children. Since many ocular
issues can be asymptomatic, vision screening plays a vital role in detecting visual disorders in children who do not show any signs of disease or impairment, thus allowing for
early diagnosis and treatment, and reducing the potential negative impact of
untreated conditions on visual development and educational and social progress. Vision therapy
is a customised therapy provided
to improve visual skills specifically in condition such as eye movement disorders, binocular vision
problems, and visual processing difficulties. Vision therapy can help improve symptoms
of conditions like convergence insufficiency, amblyopia, and strabismus. Vision Therapy helps
to enhance visual performance.
This study aims to evaluate visual risk factor and
will also help to understand ocular anomalies among urban and rural school
children
|