| CTRI Number |
CTRI/2025/12/098420 [Registered on: 03/12/2025] Trial Registered Prospectively |
| Last Modified On: |
03/12/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Pediatric Myopia participants |
|
Scientific Title of Study
|
Develop and assess the impact of Pediatric Myopia Management Protocol among Eye Care Professionals |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 1 |
Other |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sanjeeb Kumar Mishra |
| Designation |
Lecturer |
| Affiliation |
Chitkara School of Health Sciences, Chitkara University, Rajpura, Punjab 140401, India |
| Address |
Chitkara School of Health Sciences, Chitkara University, Rajpura, Punjab 140401, India
Institute of Medicine
Tribhuvan University
Department of Ophthalmology
Kathmandu
Nepal
Patiala
PUNJAB
140401
India |
| Phone |
9779841363846 |
| Fax |
|
| Email |
msanjeeb22@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sanjeeb Kumar Mishra |
| Designation |
Lecturer |
| Affiliation |
Chitkara School of Health Sciences, Chitkara University, Rajpura, Punjab 140401, India |
| Address |
Chitkara School of Health Sciences, Chitkara University, Rajpura, Punjab 140401, India
Institute of Medicine
Department of Ophthalmology
Tribhuvan University
Kathmandu
Nepal
Patiala
PUNJAB
140401
India |
| Phone |
9779841363846 |
| Fax |
|
| Email |
msanjeeb22@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Sanjeeb Kumar Mishra |
| Designation |
Lecturer |
| Affiliation |
Chitkara School of Health Sciences, Chitkara University, Rajpura, Punjab 140401, India |
| Address |
Chitkara School of Health Sciences, Chitkara University, Rajpura, Punjab 140401, India
Institute of Medicine
Department of Ophthalmology
Tribhuvan University
Kathmandu
Nepal
Patiala
PUNJAB
140401
India |
| Phone |
9779841363846 |
| Fax |
|
| Email |
msanjeeb22@yahoo.com |
|
|
Source of Monetary or Material Support
|
|
Department of Ophthalmology
Institute of Medicine
Tribhuvan University
Kathmandu
Nepal
00977 |
|
|
Primary Sponsor
|
| Name |
Dhristi Eye Hospital |
| Address |
Dhristi Eye Hospital
Kakarvita
Koshi province
Nepal
00977 |
| Type of Sponsor |
Private hospital/clinic |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
Nepal |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Sanjeeb Mishra |
Dhristi Eye Hospital |
Department of Pediatric and Binocular Vision
Room no 4
Kakarvita
Koshi Province
Nepal
|
9779841363846
msanjeeb22@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| IHEC |
Approved |
| NHRC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Pediatric Myopia |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Atropine , Different types of Myopia Control glasses and Contact Lenses |
Different types of Myopia Control glasses like Myiosmart, Stellest, Myocure,Orthokeratology, Multifocal soft contact lenses
and low dose Atropine
Duration of intervention upto 6 months |
| Comparator Agent |
Different types of Myopia Control glasses and contact lenses and low dose atropine |
Different types of Myopia Control glasses and contact lenses and low dose atropine |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
Less than or equal to 3.00 D |
|
| ExclusionCriteria |
| Details |
Non-Pediatric Myopia
Moderate and High Myopia
Greater than 3.00 D |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Stable progression in Pediatric Myopia |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction of the Pediatric Myopia Progression |
6 months |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
26/12/2025 |
| 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)
|
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
|
Pediatric myopia is a global public health problem. The practicing Eye Care professionals in Myopia Management will be guided in Koshi Province of Nepal with the Pediatric Myopia Management Protocol The data of Pediatric Myopia Management by Eye Care Professionals with different types of Myopia control glasses, contact lenses, and Low-dose Atropine will be collected in Koshi Province of Nepal. The date will be filled and submitted to the Principal Investigator |