| CTRI Number |
CTRI/2025/08/093113 [Registered on: 14/08/2025] Trial Registered Prospectively |
| Last Modified On: |
14/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Do certain personality traits affect how quickly nearsightedness gets worse in children? |
|
Scientific Title of Study
|
Exploring the association between personality traits and myopia progression in children – An observational 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 |
Dr Disha Agarwal |
| Designation |
Fellow |
| Affiliation |
Sankara Eye Hospital, Bangalore |
| Address |
Department of Pediatric Ophthalmology & Strabismus, Sankara Eye Hospital, Bangalore
Bangalore
KARNATAKA
560037
India |
| Phone |
8763742311 |
| Fax |
|
| Email |
da1001.disha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vidhya C |
| Designation |
Consultant |
| Affiliation |
Sankara Eye Hospital, Bangalore |
| Address |
Department of Pediatric Ophthalmology & Strabismus, Sankara Eye Hospital, Bangalore
Bangalore
KARNATAKA
560037
India |
| Phone |
9886404877 |
| Fax |
|
| Email |
dr.optho.vidhya@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Disha Agarwal |
| Designation |
Fellow |
| Affiliation |
Sankara Eye Hospital, Bangalore |
| Address |
Department of Pediatric Ophthalmology & Strabismus, Sankara Eye Hospital, Bangalore
Bangalore
KARNATAKA
560037
India |
| Phone |
8763742311 |
| Fax |
|
| Email |
da1001.disha@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sankara Eye Hospital, Kundalahalli Gate, Bangalore, Karnataka, India (PIN- 560037) |
|
|
Primary Sponsor
|
| Name |
Sankara Eye Hospital Bangalore |
| Address |
Sankara Eye Hospital, Kundalahalli Gate, Bangalore, Karnataka, India (PIN- 560037) |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Disha Agarwal |
Sankara Eye Hospital, Bangalore |
Department of Pediatric Ophthalmology & Strabismus
Bangalore
KARNATAKA |
8763742311
da1001.disha@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Sankara Eye Hospital, Bangalore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H521||Myopia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
1. Age 10-15 years
2. Subjective cycloplegic spherical equivalent (SE) more than/equal to -0.5D with cylindrical refraction less than -1.50D, and anisometropia less than 1.50D
3. Monocular best corrected visual acuity (BCVA) for both eyes 6/6
4. At least one documentation of refractive error within last 6 months-1year at our hospital
|
|
| ExclusionCriteria |
| Details |
1. History of any other ocular disease
2. H/o prematurity or any other systemic disease that could affect the quality of vision
3. History of any neurologic or psychiatric disorder
4. Any h/o ocular trauma/surgery
5. Parents not willing to participate
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Myopia Progression Status |
Baseline and data from 6 months back |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Degree of Myopia Progression
2. Personality Traits
3. Treatment history
4. Environmental & Familial Factors |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="350"
Sample Size from India="350"
Final Enrollment numbers achieved (Total)= "153"
Final Enrollment numbers achieved (India)="153" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/09/2025 |
| Date of Study Completion (India) |
30/11/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
30/11/2025 |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Myopia is a growing global public health concern with projections estimating that by 2050, over 740 million individuals aged 5 to 19 could be affected. The prevalence of myopia varies widely by region. For example, in East and Southeast Asia, prevalence rates can exceed 80%, while considerably lower rates are observed in other parts of the world. Myopia progression is driven by a complex interaction of genetic, environmental, and behavioural factors with key environmental contributor being increased screen time, reduced outdoor activities, and educational pressures. Personality traits significantly shape health behaviours across various domains. Traits such as neuroticism, conscientiousness, and extroversion drive our lifestyle choices and stress responses that can affect overall physical well-being. It is plausible that personality traits may indirectly affect myopia progression as well. Existing studies on the association between personality traits and myopia have primarily focused on adult populations and have shown mixed results. There is a paucity of research exploring these associations in pediatric populations which might help to decide on early intervention strategies. |