| CTRI Number |
CTRI/2025/09/095043 [Registered on: 18/09/2025] Trial Registered Prospectively |
| Last Modified On: |
18/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
eye pack and exercise for eye strain |
|
Scientific Title of Study
|
Effect Of four Week Cold Eye Compress And Eye Exercise On Ocular Quality Of Life in Digital Users -A Three Arm 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 Ananya |
| Designation |
Internee |
| Affiliation |
SDM College of Naturopathy and yogic sciences |
| Address |
dept of natural theraputics SDMCNYS,ujire , belthangadi
Dakshina Kannada
KARNATAKA
574240
India |
| Phone |
9482050760 |
| Fax |
|
| Email |
ananyaprasanna760@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ananya |
| Designation |
Internee |
| Affiliation |
SDM College of Naturopathy and yogic sciences |
| Address |
department of Natural theraputics, SDMCNYS ujire , belthangadi
Dakshina Kannada
KARNATAKA
574240
India |
| Phone |
9482050760 |
| Fax |
|
| Email |
ananyaprasanna760@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sujatha K J |
| Designation |
Dean Division of Natural Theraputics |
| Affiliation |
SDM College of Naturopathy and yogic sciences |
| Address |
dept of Natural Theraputics SDMCNYS ujire , belthangadi
Dakshina Kannada
KARNATAKA
574240
India |
| Phone |
9480401646 |
| Fax |
|
| Email |
drsujathadinesh2@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri Darmasthala Manjunatheswara Yoga and Nature cure hospital Shantivana , Dharmasthala, dakshinakannada - 574240 |
|
|
Primary Sponsor
|
| Name |
Ananya |
| Address |
SDM College of naturopathy and yogic sciences, Ujire, belthangadi, dakshinakannada -574240 |
| 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 Ananya |
Sri Dharmasthala Manjunatheshwara Yoga and Nature Cure Hospital Shantivana |
COE ,SDM naturecure Hospital Dharmasthala , belthangadi
Dakshina Kannada
KARNATAKA |
09482050760
ananyaprasanna760@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SDM College of Naturopathy and Yogic Sciences Institutional Ethics Committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H53-H54||Visual disturbances and blindness, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
COLD EYE COMPRESS + Eye Exercise |
• Participant lies in a comfortable supine position
• Cold compress applied over both closed eyes for 10 minutes
• Administered once daily, preferably in the evening post-screen use
• Duration: 30 days
|
| Intervention |
Eye Exercise |
Exercise Description Duration
Palming Rubbing hands and cupping over closed eyes 2 mins
Blinking Voluntary blinking every 5 seconds to train blink reflex 1 min
Eye movements
up and down ,sideways,diagonal Rotation Clockwise and counterclockwise slow movements 3-4 mins
Trataka (Yogic Gazing) Focusing on a fixed object (e.g., candle or black dot on wall) without blinking until tears form, then close eyes 3–5 mins
|
| Comparator Agent |
NO Intervention |
No intervention |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
digital users of more than 4 hours |
|
| ExclusionCriteria |
| Details |
Chronic eye diseases (e.g., glaucoma, cataract)
Recent eye surgery or current use of contact lenses
Skin sensitivity or allergy to cold
Current ocular medications or treatments
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Computer Vision Syndrome Questionnaire (CVS-Q) |
pre - day 1
post - day 28 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Visual Fatigue Scale (VFS) |
pre - day 1
post- day 28 |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
29/09/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
29/09/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="1"
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
|
the present study aims to evaluate the effect of a four-week intervention with cold eye compress and eye exercises, on ocular quality of life in digital users. Findings from this study may provide evidence for a non-pharmacological, low-cost, and accessible strategy to manage CVS, thereby promoting ocular health in populations increasingly dependent on digital devices. |