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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  
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 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  
Status 
Not Applicable 
 
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. 

 
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