| CTRI Number |
CTRI/2026/03/105135 [Registered on: 02/03/2026] Trial Registered Prospectively |
| Last Modified On: |
01/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Study to Evaluate an Artificial Intelligence App for the Management of Computer Vision Syndrome and Dry EyE |
|
Scientific Title of Study
|
nil |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Bhavna Tyagi |
| Designation |
Assistant professor |
| Affiliation |
Galgotias university |
| Address |
Aigin Royal,PLOT NO GH-D16, Greater Noida W Rd, Sector 1, Aimnabad, Greater Noida, Bisrakh Jalalpur, Uttar Pradesh 201318 Plot No.2, Sector 17-A Yamuna Expressway, Greater Noida, Gautam Buddh Nagar, Uttar Pradesh, India
Opposite Buddh International Circuit. Gautam Buddha Nagar UTTAR PRADESH 201316 India |
| Phone |
6397686531 |
| Fax |
|
| Email |
tyagibhavna1999@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr. Raj Kumar |
| Designation |
Professor |
| Affiliation |
Galgotias university |
| Address |
Seat no. 7 Room no 320 SAHS Department of optometry ,Plot No.2, Sector 17-A Yamuna Expressway, Greater Noida, Gautam Buddh Nagar, Uttar Pradesh, India
Opposite Buddh International Circuit.Galgotias University Greater Noida Plot No.2, Sector 17-A Yamuna Expressway, Greater Noida, Gautam Buddh Nagar, Uttar Pradesh, India
Opposite Buddh International Circuit. Gautam Buddha Nagar UTTAR PRADESH 203201 India |
| Phone |
9015872988 |
| Fax |
|
| Email |
optomrajlvpei@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Bhavna Tyagi |
| Designation |
Assistant professor |
| Affiliation |
Galgotias university |
| Address |
Aigin Royal,PLOT NO GH-D16, Greater Noida W Rd, Sector 1, Aimnabad, Greater Noida, Bisrakh Jalalpur, Uttar Pradesh 201318 Plot No.2, Sector 17-A Yamuna Expressway, Greater Noida, Gautam Buddh Nagar, Uttar Pradesh, India
Opposite Buddh International Circuit.
UTTAR PRADESH 201316 India |
| Phone |
6397686531 |
| Fax |
|
| Email |
tyagibhavna1999@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Bhavna Tyagi |
| Address |
Seat Nn 37 Room no 320 Depatment of optometry SAHS Galgotias University Plot No2 Sector 17 A Yamuna Expressway Greater Noida Gautam Buddh Nagar Uttar Pradesh 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 Raj Kumar |
Galgotias University |
Seat no 7 room no 320 Department of optometry SAHS Plot No 2 Sector 17A Yamuna Expressway opposite the Buddh International Circuit in Greater Noida Gautam Buddh Nagar Uttar Pradesh India 203201 Gautam Buddha Nagar UTTAR PRADESH |
9015872988
optomrajlvpei@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| School ethics committee galgotias university |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Normal individuals working as academicians |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
VDT users more than 2 hours a day
Individuals who self-report symptoms associated with CVS and Dry Eye Syndrome specifically attributed to VDT use
Individuals who provide consent and compliance
Good general health based on sign and symptoms
|
|
| ExclusionCriteria |
| Details |
Individuals with pre existing visual impairments or eye conditions or blepharospasm
Individuals with a history of eye surgery
Individuals who regularly wear contact lenses
Individuals with cognitive impairments or neurological conditions
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
This application will be work as prevention and management of computer vision syndrome
|
12 weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="292" Sample Size from India="292"
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)
|
01/04/2026 |
| 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="0" 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 study aims to develop and evaluate an artificial intelligence based application for the real-time assessment and management of Computer Vision Syndrome and Dry Eye Syndrome among individuals with prolonged digital screen exposure. CVS and DES are increasingly prevalent due to extensive use of computers and mobile devices, leading to symptoms such as eye strain, dryness, blurred vision, headaches, and visual fatigue, which adversely affect comfort, productivity, and quality of life.The proposed AI application will monitor user behavior and ocular indicators related to blink rate, screen usage patterns, and visual strain, and provide personalized, real-time recommendations to reduce symptom severity. The study addresses an existing research gap due to the limited availability of AI-based, user-friendly tools for continuous monitoring and early intervention in CVS and DES.The methodology involves human participants, with informed consent obtained, and does not include the use of human tissue or blood samples. Ethical considerations related to participant privacy, data security, and informed consent will be strictly followed. The expected outcome is a measurable reduction in CVS and DES symptoms, improved adherence to eye-health practices, and enhanced overall visual comfort through AI-driven monitoring and personalized management strategies. |