| CTRI Number |
CTRI/2025/09/093967 [Registered on: 01/09/2025] Trial Registered Prospectively |
| Last Modified On: |
08/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Understanding Parental Awareness and Attitudes Towards Myopia Progression Control in Children at a Tertiary Hospital |
|
Scientific Title of Study
|
Exploring parental awareness of interventions for myopia
progression control at a tertiary eye hospital -A Questionnaire based
study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Namratha |
| Designation |
Associate professor |
| Affiliation |
Sankara College of Optometry |
| Address |
Depaartment of Optometry, Sankara College of Optometry, Sankara eye hospital
Varthur main road,
Kundalahalli gate
Bangalore
Bangalore
KARNATAKA
560037
India |
| Phone |
9986266576 |
| Fax |
|
| Email |
namratha.hegde@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Namratha |
| Designation |
Associate professor |
| Affiliation |
Sankara College of Optometry |
| Address |
Depaartment of Optometry, Sankara College of Optometry, Sankara eye hospital
Varthur main road,
Kundalahalli gate
Bangalore
Bangalore
KARNATAKA
560037
India |
| Phone |
9986266576 |
| Fax |
|
| Email |
namratha.hegde@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Namratha |
| Designation |
Associate professor |
| Affiliation |
Sankara College of Optometry |
| Address |
Depaartment of Optometry, Sankara College of Optometry, Sankara eye hospital
Varthur main road,
Kundalahalli gate
Bangalore
Bangalore
KARNATAKA
560037
India |
| Phone |
9986266576 |
| Fax |
|
| Email |
namratha.hegde@gmail.com |
|
|
Source of Monetary or Material Support
|
| Nil |
| Sankara Eye Hospital, Varthur Main Road, Kundalahalli, Bengaluru, Karnataka, India 560037 |
|
|
Primary Sponsor
|
| Name |
Sankara eye hospital |
| Address |
Sankara Eye Hospital
Varthur main road
Kundalahalli gate
Bengaluru, Karnataka, 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 |
Department of Pediatric Ophtahlmology, Sankara Eye Hospital, Varthur main road,
Kundalahalli gate
Bangalore 560037 Karnataka India
Bangalore
KARNATAKA |
9986266576
namratha.hegde@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sankara Eye Hospital Bangalore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Parents with myopic child |
| Patients |
(1) ICD-10 Condition: H521||Myopia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
Parents of myopic patients,
Parents of children with age
of 5 to 16.
Parents of children who is
visiting Sankara eye
hospital.
Dioptric power from less
than or equal to -0.50
Family history of myopia
(Parents and Siblings).
Gender – Both male and
female |
|
| ExclusionCriteria |
| Details |
Hyperopic patients
Patient who is recently
diagnosed as a myopic. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Level of parental awareness and knowledge about available
interventions for controlling myopia progression in children. |
at baseline visit |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Sources of information that parents relying on.
Attitudes and beliefs regarding effectiveness and safety of
myopia control methods.
Association between demographic factors and awareness
levels.
Willingness to adopt or pay for specific myopia control
interventions.
Previous experience with myopia progression treatments. |
One day |
|
|
Target Sample Size
|
Total Sample Size="302"
Sample Size from India="302"
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)
|
15/09/2025 |
| 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="0"
Months="6"
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
|
A questionnaire based observational study on exploring parental awareness of interventions for myopia progression control at a tertiary eye hospital. The participants are recruited based on the inclusion and exclusion criteria set. This study aims to correlate the education status of parents and awareness in myopia control strategy in Indian population. |