| CTRI Number |
CTRI/2024/09/074209 [Registered on: 24/09/2024] Trial Registered Prospectively |
| Last Modified On: |
17/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Study Of Binocular Vision Parameters and Refraction Status of eye in children with on Atropine eye drops for Myopia Progression |
|
Scientific Title of Study
|
Study of Vergence, Accommodation parameters and Peripheral refraction in children with low dose atropine for progressive myopia |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SHIFA ANJUM M |
| Designation |
Post diploma DNB resident |
| Affiliation |
Sankara Eye hospital |
| Address |
Pediatrics Out Patient Department
First floor
Sankara Eye Hospital
Varthur Main Rd, Vaikuntam Layout, Lakshminarayana Pura, Kundalahalli, Munnekollal, Bengaluru
Pediatric out patient department
Kundalahalli gate Bangalore 560037
Bangalore
KARNATAKA
560037
India |
| Phone |
8971694576 |
| Fax |
|
| Email |
shifaanjum123@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SOWMYA R |
| Designation |
Pediatric and Neurophthalmology consultant |
| Affiliation |
Sankara Eye hospital |
| Address |
Pediatrics Out Patient Department
First floor
Sankara Eye Hospital
Varthur Main Rd, Vaikuntam Layout, Lakshminarayana Pura, Kundalahalli, Munnekollal, Bengaluru
Sankara Eye hospital
Pediatric out patient department
Kundalahalli gate Bangalore 560037
Bangalore
KARNATAKA
560037
India |
| Phone |
8971694576 |
| Fax |
|
| Email |
drsowmyamurthy@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
SHIFA ANJUM M |
| Designation |
Post diploma DNB resident |
| Affiliation |
Sankara Eye hospital |
| Address |
Pediatrics Out Patient Department
First floor
Sankara Eye Hospital
Varthur Main Rd, Vaikuntam Layout, Lakshminarayana Pura, Kundalahalli, Munnekollal, Bengaluru, Karnataka
Sankara Eye hospital
Kundalahalli gate
Bangalore 560037
Bangalore
KARNATAKA
560037
India |
| Phone |
8971694576 |
| Fax |
|
| Email |
shifaanjum123@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sankara eye hospital
Varthur Main Rd, Vaikuntam Layout, Lakshminarayana Pura, Kundalahalli, Munnekollal, Bengaluru, Karnataka 560037
|
|
|
Primary Sponsor
|
| Name |
SHIFA ANJUM M |
| Address |
SANKARA EYE HOSPITAL Kundalahalli Gate, Varthur Main Road, Marathahalli, Bangalore - 560037 |
| Type of Sponsor |
Other [SELF ] |
|
|
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 SHIFA ANJUM M |
SANKARA EYE HOSPITAL BANGALORE |
Pediatrics OPD
First Floor
Kundalahalli Gate, Varthur Main Road, Marathahalli, Bangalore - 560037
pediatric out patient department
Bangalore
KARNATAKA |
8971694576
shifaanjum123@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: H531||Subjective visual disturbances, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
7.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
children aged 7-18 years on low dose atropine for at least 3 months for progressive myopia |
|
| ExclusionCriteria |
| Details |
children who are on additional intervention for control of myopia like orthokeratology and DIMS lenses |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Effect of low dose Atropine on Vergence , Accommodation parameters and Peripheral refraction |
Atleast for 3 months on Atropine |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Effect of duration & concentration of tropine if any on the binocular vision parameters & peripheral refraction
Effect on the binocular parameters vary with the refractive state
|
Atleast for 3 months on Atropine |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
13/10/2024 |
| 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="10"
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
|
children aged 7-18 years visiting pediatric opd at sankara eye hospital bangalore on low dose atropine for progressive myopia for at least 3 months will be studied for vergence parameters , accommodation parameters and peripheral refraction. |