| CTRI Number |
CTRI/2025/02/081346 [Registered on: 25/02/2025] Trial Registered Prospectively |
| Last Modified On: |
22/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Survey on eye disease related to prolonged screen time users |
|
Scientific Title of Study
|
A cross sectional study on association between prolonged screen time and incidence of ocular problem |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Megha Patil |
| Designation |
final year BAMS student |
| Affiliation |
shri siddhivinayak rural ayurvedic medical college harugeri 591220 |
| Address |
Shri Siddhivinayak Rural Ayurvedic Medical College Harugeri 591220
Belgaum
KARNATAKA
591220
India |
| Phone |
9844607401 |
| Fax |
|
| Email |
meghaanandapatil2001@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mananda Mirje |
| Designation |
Professor AND HOD |
| Affiliation |
shri siddhivinayak rural ayurvedic medical college harugeri 591220 |
| Address |
Department of Shalakaya Tantra Shri Siddivinayak Rural Ayurvedic Medical College Harugeri 591220
Belgaum
KARNATAKA
591220
India |
| Phone |
9900393546 |
| Fax |
|
| Email |
drmmmirje@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mananda Mirje |
| Designation |
Professor AND HOD |
| Affiliation |
shri siddhivinayak rural ayurvedic medical college harugeri 591220 |
| Address |
Department of Shalakya Tantra Shri Siddivinakayak Rural Ayurvedic Medical College Harugeri 591220
Belgaum
KARNATAKA
591220
India |
| Phone |
9900393546 |
| Fax |
|
| Email |
drmmmirje@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri Siddhivinayak Rural Ayurveda Medical College Harugeri 591220 Karnataka India |
|
|
Primary Sponsor
|
| Name |
Central council for Research in Ayurvedic Sciences |
| Address |
61-65 Institutional Area Opp D Block Janakpuri New Delhi 110058 India |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| NOT APLLICABLE |
NIL |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Megha Patil |
Shri Siddivinayak Rural Ayurvedic Medical College |
Shri Siddhivinayak Rural Ayurvedic Medical College Ground Floor 1st Room Shalakya Tantra Department Harugeri 591220
Belgaum
KARNATAKA |
9844607401
meghaanandapatil2001@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Commitee of Shri Siddivinayak Rural Ayurvedic Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
SURVEY Study include only more than 3hrs screen time users
Study include age group of more than 16year |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Study include only more than 3hrs screen time users
Study include age group of more than 16year |
|
| ExclusionCriteria |
| Details |
Study exclude with age group of less than 16 year
Participants who have other ocular pathologies, infections, foreign bodies, or trauma to the eye
Participants who have severe systemic diseases like sjoergen syndrome, hypertension tension and diabates
etc |
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Statistical values related to prlonged screen time users and occular problems |
2 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Finding out statastical value of occular problem in prolonged screen time users |
2 months |
|
|
Target Sample Size
|
Total Sample Size="250"
Sample Size from India="250"
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)
|
08/03/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
08/03/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
250 prolonged screen time users were selected (randomly who have attained inclusion criteria) Enrolment and Consent Structured Questionnaire will be given to answer and Collecting the information from questionnaire method information will analyse statistically write down the Discussion Results and Conclusion about the study
|