| CTRI Number |
CTRI/2025/07/090663 [Registered on: 10/07/2025] Trial Registered Prospectively |
| Last Modified On: |
20/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A research to develop and test the effectiveness of a questionnaire to determine how well parents in India understand myopia (nearsightedness) and its treatment options. |
|
Scientific Title of Study
|
Development and validation of a questionnaire on parental awareness on myopia and control strategies |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Maria Michelle Correya |
| Designation |
Master of Optometry student |
| Affiliation |
Manipal College of Health Professions |
| Address |
Dept. of Optometry, Manipal College of Health Professions,
Manipal Academy of Higher Education, Madhav Nagar, Manipal-576104 Karnataka, India.
Udupi
KARNATAKA
576104
India |
| Phone |
7994968643 |
| Fax |
|
| Email |
maria1.mchpmpl2024@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Mr Premjit Bhakat |
| Designation |
Assistant Professor-Senior scale |
| Affiliation |
Manipal College of Health Professions |
| Address |
Dept. of Optometry, Manipal College of Health Professions,
Manipal Academy of Higher Education, Madhav Nagar, Manipal-576104 Karnataka, India.
Sharada hostel,
Mahe hostels, Manipal-576104 Karnataka, India.
Udupi
KARNATAKA
576104
India |
| Phone |
97425 03244 |
| Fax |
|
| Email |
premjit.bhakat@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Maria Michelle Correya |
| Designation |
Master of Optometry student |
| Affiliation |
Manipal College of Health Professions |
| Address |
Dept. of Optometry, Manipal College of Health Professions,
Manipal Academy of Higher Education, Madhav Nagar, Manipal-576104 Karnataka, India.
Udupi
KARNATAKA
576104
India |
| Phone |
7994968643 |
| Fax |
|
| Email |
maria1.mchpmpl2024@learner.manipal.edu |
|
|
Source of Monetary or Material Support
|
| Manipal College of Health Professions (MCHP), Manipal Academy of Higher Education (MAHE), Madhav Nagar, Manipal, Udupi, Karnataka – 576104, India. |
|
|
Primary Sponsor
|
| Name |
Manipal College of Health Professions |
| Address |
Dept. of Optometry, Manipal College of Health Professions,
Manipal Academy of Higher Education, Madhav Nagar, Manipal-576104 Karnataka, India. |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Mr Premjit Bhakat |
Manipal College of Health Professions |
Dept. of Optometry, Manipal College of Health Professions,
Manipal Academy of Higher Education, Madhav Nagar, Manipal-576104 Karnataka, India.
Udupi
KARNATAKA |
9742503244
premjit.bhakat@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee (KMC & KH IEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Z01.00 – Encounter for examination of eyes and vision without abnormal findings |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
25.00 Day(s) |
| Age To |
70.00 Day(s) |
| Gender |
Both |
| Details |
1.Professionals with expertise in myopia management and a minimum of 3 years of experience.
2.Eye care nurses who are involved in managing children with myopia.
3.Parents of myopic children aged between 5 to 15 years.
|
|
| ExclusionCriteria |
| Details |
1.Professionals whose primary area of expertise does not involve myopia management.
2.Parents who are professionals in the eye care field as part of their occupation. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To develop a questionnaire to identify the parental awareness and perception pattern and towards myopia in an Indian population. |
AT BASELINE
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To validate a questionnaire to identify the parental awareness & perception pattern & towards myopia in an Indian population.
|
AT BASELINE |
|
|
Target Sample Size
|
Total Sample Size="5"
Sample Size from India="5"
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)
|
01/08/2025 |
| 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)
|
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
|
The project titled "Development and Validation of a Questionnaire on Parental Awareness on Myopia and Control Strategies" is a prospective, cross-sectional study aimed at creating and validating a tool to assess parental awareness and perceptions regarding myopia and its control measures in the Indian context. With the rising prevalence of myopia among children, there is growing concern that limited parental knowledge may be contributing to delayed or inadequate intervention. Understanding parents’ perspectives is crucial for clinicians to recommend appropriate and individualized treatment plans for effective myopia management. A culturally relevant, population-specific questionnaire will serve as a vital resource for identifying awareness gaps and guiding the design of targeted awareness campaigns and public health strategies to manage and control myopia in Indian children. |