| CTRI Number |
CTRI/2025/08/093583 [Registered on: 25/08/2025] Trial Registered Prospectively |
| Last Modified On: |
23/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Impact of Yoga on Refractive Status and Axial Length |
|
Scientific Title of Study
|
Impact of Yoga on Refractive Status and Axial Length In School Children: A Prospective Interventional Study |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vandana Kamath |
| Designation |
Head of Department |
| Affiliation |
Sankara Eye Hospital, Bangalore |
| Address |
Deparment of Optometry, Sankara College of optometry, Sankara Eye Hospital,
Varthur Main Road, Kunadalahalli Gate, Bangalore
Deparment of Optometry, Sankara College of optometry,Sankara Eye Hospital,
Varthur Main Road, Kunadalahalli Gate, Bangalore
Bangalore
KARNATAKA
560037
India |
| Phone |
09820541584 |
| Fax |
|
| Email |
vandu2388@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vandana Kamath |
| Designation |
Head of Department |
| Affiliation |
Sankara Eye Hospital, Bangalore |
| Address |
Department of Optometry, Sankara College of optometry,Sankara Eye Hospital,
Varthur Main Road, Kunadalahalli Gate, Bangalore
Department of Optometry, Sankara College of optometry,Sankara Eye Hospital,
Varthur Main Road, Kunadalahalli Gate, Bangalore
Bangalore
KARNATAKA
560037
India |
| Phone |
09820541584 |
| Fax |
|
| Email |
vandu2388@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vandana Kamath |
| Designation |
Head of Department |
| Affiliation |
Sankara Eye Hospital, Bangalore |
| Address |
Department of Optometry, Sankara College of optometry,Sankara Eye Hospital,
Varthur Main Road, Kunadalahalli Gate, Bangalore
Department of Optometry, Sankara College of optometry,Sankara Eye Hospital,
Varthur Main Road, Kunadalahalli Gate, Bangalore
Bangalore
KARNATAKA
560037
India |
| Phone |
09820541584 |
| Fax |
|
| Email |
vandu2388@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sankara Eye Hospital
Varthur Main Road, Kundalahalli Gate, Bangalore, India 560037 |
|
|
Primary Sponsor
|
| Name |
Sankara Eye Hospital |
| Address |
Sankara Eye Hospital, Varthur main road,Bangalore, India 560037 |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 Namratha |
Sankara Eye Hospital |
Sankara eye hospital, Varthur Main Road, Kundalahalli SIgnal, Bengaluru 560037
Bangalore
KARNATAKA |
09820541584
vandu2388@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sankara Eye Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Subjects with Refractive error and without refractive error |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
| Intervention |
Yoga Therapy for 6 months |
1. Kriya
2. Asanas
3. Pranayama
4. Relaxation yoga |
|
|
Inclusion Criteria
|
| Age From |
8.00 Year(s) |
| Age To |
13.00 Year(s) |
| Gender |
Both |
| Details |
School going children with and without refractive error are included into the study |
|
| ExclusionCriteria |
| Details |
1. Ocular Surgery
2. History of Neurological Disorder
3. Media Opacity
4. Active Ocular Pathological Diseases
5. Strabismus
6. Amblyopia |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| By Observing both pre and post interventional ocular Parameters of school children: refractive status, axial length and choroidal thickness are analysed |
Baseline- 6 months and followup |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="644"
Sample Size from India="644"
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)
|
05/09/2025 |
| 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="26"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
1. Institutional scientific and ethics approval has been taken 2. Design and duration: Prospective Interventional Study. July 2025- June 2026 3. Sample: 644 school children (8-13 yrs), Case and control schools will be included 4. To assess effect of yoga therapy for 6 months on refractive status , axial length and choroidal thickness 5. Baseline ocular examination: history, visual acuity, refraction) will be evaluated at schools and further diagnostic test like axial length, oct and corneal topography at Sankara Eye Hospital 6. Yoga Module will be given for intervention group for 6 months and reassessment will be done at 6 months 7. Descriptive Analysis will be done and compare pre and post intervention (6months) data of axial length, refractive status and choroidal thickness |