| CTRI Number |
CTRI/2019/01/017010 [Registered on: 09/01/2019] Trial Registered Prospectively |
| Last Modified On: |
10/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of low dose Atropine Eye drops in children with Short-Sightedness. |
|
Scientific Title of Study
|
Effect of 0.01% Atropine in children with Myopia |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
RASHMI K |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
DEPARTMENT OF OPHTHALMOLOGY
ROOM NO 12 SECOND FLOOR NEW OPD BLOCK KASTURBA MEDICAL COLLEGE AND HOSPITALS MANIPAL
Udupi
KARNATAKA
576 104
India |
| Phone |
9535619091 |
| Fax |
|
| Email |
rashmi.manipal93@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR VIJAYA PAI H |
| Designation |
PROFESSOR AND HEAD OF THE UNIT |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
DEPARTMENT OF OPHTHALMOLOGY
ROOM NO 12 SECOND FLOOR NEW OPD BLOCK KASTURBA MEDICAL COLLEGE AND HOSPITALS MANIPAL
Udupi
KARNATAKA
576 104
India |
| Phone |
9845426427 |
| Fax |
|
| Email |
pai.vijaya@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
RASHMI K |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
DEPARTMENT OF OPHTHALMOLOGY
ROOM NO 12 SECOND FLOOR NEW OPD BLOCK KASTURBA MEDICAL COLLEGE AND HOSPITALS MANIPAL
Udupi
KARNATAKA
576 104
India |
| Phone |
9535619091 |
| Fax |
|
| Email |
rashmi.manipal93@gmail.com |
|
|
Source of Monetary or Material Support
|
| DEPARTMENT OF OPHTHALMOLOGY NEW OPD BLOCK SECOND FLOOR KASTURBA HOSPITAL AND MEDICAL COLLEGE MANIPAL |
|
|
Primary Sponsor
|
| Name |
RASHMI K |
| Address |
DEPARTMENT OF OPHTHALMOLOGY
ROOM NO 12 SECOND FLOOR NEW OPD BLOCK KASTURBA MEDICAL COLLEGE AND HOSPITALS MANIPAL
|
| 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 RASHMI K |
Kasturba Medical College and Hospitals |
Department of ophthalmology,New opd block,Second floor,Room no 12, Manipal
Udupi
KARNATAKA |
9535619091
rashmi.manipal93@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committe |
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 |
0.01% ATROPINE EYE DROPS |
DOSE 0.01%
FREQUENCY ONCE IN THE NIGHT DAILY
ROUTE OF ADMINISTRATION TOPICAL EYE DROPS
DURATION OF THERAPY ONE AND HALF YEARS |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
Children both male and female aged 6-18 years with compound myopia of atleast -2.00D or more and astigmatism -1.50 D or less attending Ophthalmology OPD in Kasturba Medical College, Manipal
|
|
| ExclusionCriteria |
| Details |
1.Myopia due to glaucoma
2.Any ocular trauma
3.Any ocular surgery |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Degree of myopia progression defined as change in spherical equivalent over 2 years study period as measured by cycloplegic refraction.
Change in axial length as measured by IOL master.
|
Degree of myopia progression defined as change in spherical equivalent over 2 years study period as measured by cycloplegic refraction.
Change in axial length as measured by IOL master.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Side effects of long term use of 0.01% Atropine eye drops |
Assessed every 6 months for the period of 2 years |
|
|
Target Sample Size
|
Total Sample Size="104"
Sample Size from India="104"
Final Enrollment numbers achieved (Total)= "104"
Final Enrollment numbers achieved (India)="104" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/01/2019 |
| Date of Study Completion (India) |
09/09/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
NONE YET |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
Myopia also known as ’SHORT SIGHT’ is a refractive error in which incident parallel rays come to focus anterior to the retina when accomodation is at rest.Control of myopia progression has become an important goal because of concerns regarding significantly increased risk of retinal detachment,glaucoma,retinal degeneration and cataract associated with high myopia.Atropine sulfate eye drops has consistently been demonstrated to inhibit axial myopia progression in both humans and animal models. Recently 0.01% Atropine eye drops has been shown to be effective in arresting myopia progression without side effects of cycloplegia,near vision impairment,pupil dilatation and increased light sensitivity.So we plan to evaluate the efficacy and safety of topical 0.01% Atropine eye drops in slowing progression of myopia and ocular elongation in our population. Children aged 6 - 18 years coming to ophthalmology OPD of Kasturba Medical College, Manipal who are diagnosed with compound Myopia of -2.00D or more and astigmatism of -1.50D or less in one or both eyes will be included in the study. |