| CTRI Number |
CTRI/2025/10/096134 [Registered on: 16/10/2025] Trial Registered Prospectively |
| Last Modified On: |
15/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effectiveness of Visual Exercises Versus Ocular Exercises On Eye Fatigue In Subjects With Eye Strain :A Randomized Clinical Trial |
|
Scientific Title of Study
|
Effectiveness of the Bates method v/s Oculomotor exercises on visual acuity and eye fatigue in individuals with Digital eye strain: A Randomized clinical trial |
| 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 sushmita badiger |
| Designation |
MPT |
| Affiliation |
KLES Institute of Physiotherapy Belgaum |
| Address |
KLES DR. Prabhakar kore Hospital and MRC, Biomechanics Department Room 18, Nehru Nagar, Belagavi.
Belgaum
KARNATAKA
590010
India |
| Phone |
8317424117 |
| Fax |
|
| Email |
sushmitabadiger195@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr sushmita badiger |
| Designation |
MPT |
| Affiliation |
KLES Institute of Physiotherapy Belgaum |
| Address |
KLES DR. Prabhakar kore Hospital and MRC, Biomechanics Department Room 18, Nehru Nagar, Belagavi.
KARNATAKA
590010
India |
| Phone |
8317424117 |
| Fax |
|
| Email |
sushmitabadiger195@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Harshawardhan Kudale |
| Designation |
MPT |
| Affiliation |
KLES Institute of Physiotherapy Belgaum |
| Address |
KLES DR. Prabhakar kore Hospital and MRC, Biomechanics Department Room 18, Nehru Nagar, Belagavi.
Belgaum
KARNATAKA
590010
India |
| Phone |
7208810180 |
| Fax |
|
| Email |
harshawardhansk29@gmail.com |
|
|
Source of Monetary or Material Support
|
| kaher institute of physiotherapy nehru nagar belgavi 590010 |
|
|
Primary Sponsor
|
| Name |
Harshawardhan kudale |
| Address |
KLES DR. Prabhakar kore Hospital and MRC, Biomechanics Department Room 18, Nehru Nagar, Belagavi. |
| 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 Harshawardhan kudale PT |
KLES DR PRABHAKAR KORE HOSPITAL |
Advanced Physiotherapy Centre, Room Number 18, Department of Biomechanics, Nehru Nagar, 590010, Belagavi.
Belgaum
KARNATAKA |
7208810180
harshawardhansk29@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| kle academy of higher education and research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
eye strain |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
bates method |
Vision training exercises help relax and train the eyes for better focus and visual clarity. Palming involves gently covering closed eyes with the palms while imagining darkness or colors. Sunning consists of closing the eyes and exposing the eyelids to natural or soft light. Shifting trains the eyes to move smoothly between objects while keeping the head still. The Swings involve moving the body or head side to side while observing or imagining swinging objects. Lastly, visualization focuses on mentally picturing shapes or colors clearly. Each exercise is performed for 10 repetitions over 3 sets. |
| Intervention |
oculomotor exercise |
Oculomotor exercises aim to improve eye movement control and visual stability. These include saccadic eye movements, where the eyes shift quickly between two targets with the head still; and smooth pursuit, which involves tracking a moving target with the eyes while keeping the head stationary. Gaze stabilization exercises are performed both sitting and standing, requiring horizontal head movements while maintaining focus on a fixed target. Lastly, the visuo-vestibular exercise involves moving the head, eyes, and target together while keeping the eyes focused on the target. Each exercise is performed for 10 repetitions over 3 sets. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Age group between 18-40years,People using Digital devices/viewing screen or with the screen time for 6 hours or more,CVS-Q score higher than or equal to 6 ,Willingness to participate.
|
|
| ExclusionCriteria |
| Details |
History of Systemic ocular pathology (diabetes mellitus, hypertension), History of Strabismic anomaly(hypertropia, hypotropia), People undergoing any kind of vision therapy, History of Hypermetropia, Myopia, Cataract, Glaucoma, History of Neurological disorders(Myasthenia
gravis, Stroke, TBI, Optic neuritis)
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Patient satisfaction scale |
which will be assessed at baseline and after 3 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Eye risk level questionnaire |
which will be assessed at baseline & after 3 weeks |
| Dynamic Visual Acuity |
which will be assessed at baseline & after 3 weeks |
|
|
Target Sample Size
|
Total Sample Size="68"
Sample Size from India="68"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
11/11/2025 |
| 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="0"
Months="6"
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
|
This randomized clinical trial investigates the effectiveness of the Bates method compared to oculomotor rehabilitation in improving visual acuity and reducing eye fatigue in individuals experiencing digital eye strain (DES). DES is a common condition among frequent digital device users, characterized by symptoms such as eye discomfort, blurred vision, dryness, and headaches, resulting from prolonged screen exposure. The study targets computer users aged 18 to 40 years, with a particular focus on young adults aged 18-25.The research methodology involves assigning participants to either the Bates method group or the oculomotor rehabilitation group. The Bates method, a vision improvement technique developed by William H. Bates, aims to reduce eye muscle strain through relaxation exercises. Oculomotor rehabilitation focuses on enhancing eye muscle coordination, focus flexibility, and reducing symptoms of eye strain through targeted exercises. Visual acuity measurements are conducted using standardized tools such as the Snellen chart and dynamic visual acuity tests, while eye fatigue levels are evaluated using validated questionnaires like the Computer Vision Syndrome Questionnaire (CVS-Q). |