| CTRI Number |
CTRI/2025/07/091585 [Registered on: 24/07/2025] Trial Registered Prospectively |
| Last Modified On: |
28/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To understand the effect of food intake on eye power among children between 7-12 years |
|
Scientific Title of Study
|
ASSOCIATION BETWEEN NUTRITIONAL INTAKE AND REFRACTIVE ERROR AMONG CHILDREN AGED BETWEEN 7-12 YEARS |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rishika Mallick |
| Designation |
Student pursuing Masters of Optometry |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department Of Optometry, Manipal College of Health Professions, MAHE, Manipal.
Udupi
KARNATAKA
576104
India |
| Phone |
8250749107 |
| Fax |
|
| Email |
rishika1.mchpmpl2024@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Ms Judith Shefali Jathanna |
| Designation |
Assistant professor-senior scale |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department Of Optometry, Manipal College of Health Professions, MAHE, Academic tower II, Behind MMMC, Manipal.
Udupi
KARNATAKA
576104
India |
| Phone |
9008754240 |
| Fax |
|
| Email |
Judith.jathanna@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Daksha Kumari |
| Designation |
Assistant Professor |
| Affiliation |
Manipal College of Health Professions |
| Address |
Clinical Nutrition and Dietetics Programme, Manipal College of Health Professions, MAHE, Manipal.
Udupi
KARNATAKA
576104
India |
| Phone |
7406109925 |
| Fax |
|
| Email |
Daksha.kumary@manipal.edu |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Rishika Mallick |
| Address |
Department Of Optometry, Manipal College of Health Professions, MAHE, Manipal. |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Rishika Mallick |
Kasturba Hospital |
Department of Paediatrics, Kasturba Hospital, Manipal
Udupi
KARNATAKA |
8250749107
rishika1.mchpmpl2024@learner.manipal.edu |
| Rishika Mallick |
Kasturba Hospital |
Optometry Clinic,Kasturba Hospital, Manipal
Udupi
KARNATAKA |
8250749107
rishika1.mchpmpl2024@learner.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-2 (Student Research) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Children of age ranging from 7 to 12 years, both genders will be included.
|
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
7.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Children aged between 7 to 12 years
Both genders
|
|
| ExclusionCriteria |
| Details |
Children diagnosed with any systemic diseases
Children diagnosed with any ocular disease
Children underwent any ocular surgeries
Children using any ocular medications
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
•Refractive power in Dioptres
•Nutritive value in grams and Energy in kcal
|
At 1st visit |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="78"
Sample Size from India="78"
Final Enrollment numbers achieved (Total)= "78"
Final Enrollment numbers achieved (India)="78" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
04/08/2025 |
| Date of Study Completion (India) |
21/11/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| 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
|
Aim: To study an association between nutritional intake and refractive error among children aged between 7-12 years. Primary objective: To measure the refractive power and dietary intake among children aged 7-12 years. Secondary objective(s): To correlate the refractive power and dietary intake among children aged 7-12 years. Justification for study: A well-structured study involving a diverse sample of children is essential to confirm the association between nutritional intake and refractive error. This study will help to understand the association between dietary intake and refractive error. Future awareness among parents or guardians about the link between refractive errors and a nutritional diet can be created. This could help control or reduce the risk, as dietary adjustments may mitigate early vision issues. |