| CTRI Number |
CTRI/2025/02/080115 [Registered on: 07/02/2025] Trial Registered Prospectively |
| Last Modified On: |
13/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective Experimental Study |
| Study Design |
Other |
|
Public Title of Study
|
MyoRisk score model for Pre-Myopic children at tertiary eye care centre |
|
Scientific Title of Study
|
Validation of the MyoRisk score model among Pre-Myopic children at tertiary eye care centre |
| 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 the Department |
| Affiliation |
Sankara college of optometry/ Sankara Eye Hospital |
| Address |
Sankara eye hospital Varthur main road Kundalahalli gate Marathahalli
Sankara eye hospital Varthur main road Kundalahalli gate Marathahalli
Bangalore
KARNATAKA
560037
India |
| Phone |
09820541584 |
| Fax |
|
| Email |
sco@sankaraeye.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vandana Kamath |
| Designation |
Head of the Department |
| Affiliation |
Sankara college of optometry/ Sankara Eye Hospital |
| Address |
Sankara eye hospital, Department of Optometry, Varthur main road Kundalahalli gate Marathahalli
Sankara eye hospital Varthur main road Kundalahalli gate Marathahalli
KARNATAKA
560037
India |
| Phone |
09820541584 |
| Fax |
|
| Email |
sco@sankaraeye.com |
|
Details of Contact Person
Public Query
|
| Name |
Vandana Kamath |
| Designation |
Head of the Department |
| Affiliation |
Sankara college of optometry/ Sankara Eye Hospital |
| Address |
Sankara eye hospital, Department of Optometry, Varthur main road Kundalahalli gate Marathahalli
Sankara eye hospital Varthur main road Kundalahalli gate Marathahalli
KARNATAKA
560037
India |
| Phone |
09820541584 |
| Fax |
|
| Email |
sco@sankaraeye.com |
|
|
Source of Monetary or Material Support
|
| Sankara Eye Hospital, Bangalore, Karnataka 560037 |
|
|
Primary Sponsor
|
| Name |
Sankara Eye Hospital |
| Address |
Sankara eye hospital, Bangalore, Karnataka |
| 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, Bangalore, Karnataka |
Sankara eye hospital Varthur main road Kundalahalli gate Marathahalli
Sankara eye hospital Varthur main road Kundalahalli gate Marathahalli
Bangalore
KARNATAKA |
09820541584
sco@sankaraeye.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Age group of 5-18 years |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
Pre-Myopia: +0.75DS to -0.25DS |
|
| ExclusionCriteria |
| Details |
Corneal abnormalities
Amblyopia & Strabismus
Aphakia & Pseudophakia
Systemic diseases that influence refractive error |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the MyoRisk score model among pre-myopic children |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To correlate risk factors with severity of myopia among pre-myopic children |
3 months |
|
|
Target Sample Size
|
Total Sample Size="264"
Sample Size from India="264"
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)
|
20/02/2025 |
| 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="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
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
|
Validation of the MyoRisk score model that is developed with the possible risk factor that would lead to the progression of pre-myope to myope among pre-myopic children visiting tertiary eye care centre. The developed risk factors are correlated with the severity of myopia. This study would give awareness and proper management among the pre-myopic children |