| CTRI Number |
CTRI/2026/02/104785 [Registered on: 25/02/2026] Trial Registered Prospectively |
| Last Modified On: |
30/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive Screening Other (Specify) [Vision Therapy] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study of Eye-Related Discomfort and Effectiveness of Vision Therapy as its Management in Young Adults. |
|
Scientific Title of Study
|
Visual Discomfort Profile and Efficacy of Optometric Intervention as a Management Modality in Discomfort Associated with Internal Symptom Factor among a Cohort of Young Adults |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Reshma Ramakrishnan |
| Designation |
Professor, Department of Ophthalmology |
| Affiliation |
MGM Institute of Health Sciences |
| Address |
Department of Opthalmology, MGM Medical College and Hospital, Kamothe,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 |
Dr Reshma Ramakrishnan |
| Designation |
Professor, Department of Ophthalmology |
| Affiliation |
MGM Institute of Health Sciences |
| Address |
Department of Opthalmology, MGM Medical College and Hospital, Kamothe,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 |
Misba Khan |
| Designation |
Ph.D Scholar |
| Affiliation |
MGM Institute of Health Sciences |
| 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 |
7400338372 |
| Fax |
|
| Email |
khanmisba325@gmail.com |
|
|
Source of Monetary or Material Support
|
| MGM Institute of Health Sciences |
|
|
Primary Sponsor
|
| Name |
Dr Reshma Ramakrishnan |
| Address |
Department of Opthalmology, MGM Medical College and Hospital Kamothe, 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, MGMIHS |
Department of Opthalmology, MGM Medical College and Hospital, Kamothe,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 |
9930007490
anandreshma@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics 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 |
Visual Discomfort |
| Patients |
(1) ICD-10 Condition: H533||Other and unspecified disorders ofbinocular vision, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Optometric Management Modality |
Optometric Management Modality consisting of Optical Correction and Vision Therapy will be carried out for 12 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
Participants in the age group of 18-35 years
Participants with the BCVA 6/6, N6.
Participants with Asthenopic symptoms.
Participants of either gender
Participants who provide consent form and are willing to be part of the study
|
|
| ExclusionCriteria |
| Details |
Participants with known cases of ocular pathologies inclusive of surface disorder
Participants with binocular vision anomalies due to constant strabismus, amblyopia, and anisometropia more than 2.00 Diopters
Participants with NSBV (Nonstrabismic binocular vision) anomalies on treatment.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Mean difference in Visual Discomfort Questionnaire and Binocular Vision Dysfunction Questionnaire total scores pre- and post-optometric intervention.
2.Reduction in severity of symptoms related to Internal Symptom Factor
3.Prevalence and type of Symptom Factor Contributing to visual discomfort |
12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Change in visual attention, reading rate and accuracy parameters before and after intervention.
2.Changes in binocular vision parameters.
3.Association between:Visual Discomfort Questionnaire,
Binocular Vision Dysfunction Questionnaire scores and clinical binocular vision findings.
4.Association between Visual discomfort severity and reading/attention performance.
5.Differential improvement in individual symptoms related to the Internal Symptom Factor.
|
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
|
Visual discomfort encompasses a range of adverse symptoms which occur in response to a viewing environment with varied stimuli. When the visual system operates near its physiological limits for an extended period, it results in exhaustion, which often manifests as visual stress or discomfort. A key contributor to visual discomfort is Near Point Stress, which is often triggered during or after a task that requires prolonged visual attention. It is frequently associated with digital screen use, reading, and other close work. Young adults, particularly students and early professionals, are frequently engaged in near vision tasks and digital devices, which increases their risk of experiencing visual discomfort. The causes of visual discomfort are varied, and based on symptom factor analysis, it can be broadly classified as External Symptom Factor (ESF) and Internal Symptom Factor (ISF). ESF consist of symptoms such as burning, irritation, tearing, and dryness caused by open eyelids, glare, up gaze, small font, and flickering. which is highly related to dry-eye symptoms whereas ISF consist of symptoms of ache, strain behind the eyes. and headache located behind the eyes. which are caused by the close viewing distance, ametropia, accommodative, and vergence stress. ISF is often associated with asthenopia and owing to the transient nature, diverse causes and manifestations of visual discomfort, a comprehensive assessment of visual skills is essential for accurately diagnosing any dysfunctions. Anomalies of accommodation, vergence, eye movement, and refractive status have been managed effectively using lenses, prisms, and vision therapy interventions. This study aims to screen a cohort of young adults for symptoms of visual discomfort using the Visual Discomfort Questionnaire (VDQ) and Binocular Vision Dysfunction Questionnaire (BVDQ). Participants with suggestive scores will undergo detailed diagnostic evaluations, and on diagnosis, visual dysfunctions will be categorized and managed accordingly using optometric intervention in the form of optical correction and vision therapy. This study will also assess the effectiveness of these interventions over a period of 12 week. |