| CTRI Number |
CTRI/2025/07/090393 [Registered on: 07/07/2025] Trial Registered Prospectively |
| Last Modified On: |
15/04/2026 |
| 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 on how physical activity affects eye dryness and tear function in young adults who use screen frequently |
|
Scientific Title of Study
|
Relationship between physical activity, tear film functions and dry eye symptoms
in moderate-high screen users among 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 |
Sudeeksha |
| Designation |
student pursuing Master of Optometry |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of Optometry, Manipal College of Health Professions, MAHE, MANIPAL- 576104
Udupi
KARNATAKA
576104
India |
| Phone |
8971929508 |
| Fax |
|
| Email |
sudeeksha.mchpmpl2024@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Premjit Bhakat |
| Designation |
Assistant Professor - Senior Scale |
| Affiliation |
Manipal College of Health Professions |
| Address |
Room No. 303, Third floor, Department of Optometry
Manipal College of Health Professions, MAHE, MANIPAL- 574104
Udupi
KARNATAKA
576104
India |
| Phone |
9742503244 |
| Fax |
|
| Email |
premjit.bhakat@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Premjit Bhakat |
| Designation |
Assistant Professor - Senior Scale |
| Affiliation |
Manipal College of Health Professions |
| Address |
Room No. 303, Third floor, Department of Optometry
Manipal College of Health Professions, MAHE, MANIPAL- 574104
Udupi
KARNATAKA
576104
India |
| Phone |
9742503244 |
| Fax |
|
| Email |
premjit.bhakat@manipal.edu |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Manipal College of Health Professions |
| Address |
Department of Optometry, Manipal College of Health Professions, Manipal Academy of Higher Education, MANIPAL- 576104 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Sudeeksha |
Manipal College of Health Professions ( MCHP) |
Room No. 313, Pre-clinical lab, third floor, Department of Optometry, MCHP, MAHE, MANIPAL- 576104
Udupi
KARNATAKA |
08971929508
sudeeksha.mchpmpl2024@learner.manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Research Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
healthy participants with or without dry eye |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
26.00 Year(s) |
| Gender |
Both |
| Details |
Individuals who are using at least 4 hours of
screen time/day
Individual who can understand English |
|
| ExclusionCriteria |
| Details |
Individuals with any systemic conditions
Any history of ocular trauma/ surgery
History of using any dry eye medications for the last 15 days |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Subjective measure of dry eye symptoms among the subjects |
At baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Tear secretion & tear film stability in two different groups |
At baseline |
| Complete & partial blink rate in blink per minute |
At baseline |
|
|
Target Sample Size
|
Total Sample Size="74"
Sample Size from India="74"
Final Enrollment numbers achieved (Total)= "74"
Final Enrollment numbers achieved (India)="74" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/08/2025 |
| Date of Study Completion (India) |
19/01/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
19/01/2026 |
|
Estimated Duration of Trial
|
Years="0"
Months="9"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Title of the project: Relationship between physical activity, tear film functions and dry eye symptoms
in moderate-high screen users among young adults
Type of Study: Prospective study- cross sectional study
Aim: To study the relationship between physical
activity and tear film functions and dry eye symptoms among moderate-high screen users.
Objectives: Objective 1: To compare the quality and quantity of tear film among physically active and
sedentary lifestyle subjects. Objective 2: To analyze the subjective symptoms of dry eye using OSDI among two different groups. Objective 3: To compare the complete and partial blink rate among the subjects. Objective 4: To find the correlation between physical activity and tear film functions
Materials and methods Study design: Observational study Study setting: Optometry department MCHP Study period: One year Study participants: Any individuals (meets inclusion criteria) following eligibility screening volunteer will
be recruited through advertisement.
Outcome measures: Subjective measure of dry eye symptoms among the subjects Tear secretion and tear film stability in two different groups Complete and partial blink rate in blink per minute
|