| CTRI Number |
CTRI/2018/03/012348 [Registered on: 06/03/2018] Trial Registered Prospectively |
| Last Modified On: |
05/03/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Atropine eye drops to decrease myopia progression in children |
|
Scientific Title of Study
|
Role of atropine 0.01% drops for controlling progression of myopia in children |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Drsiddharth sharma |
| Designation |
Junior resident |
| Affiliation |
Government Medical College and Hospital, Chandigarh |
| Address |
Department of ophthalmology,
Govt medical college
Chandigarh
Chandigarh
CHANDIGARH
160022
India |
| Phone |
|
| Fax |
|
| Email |
responsesid28@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rakesh kumar bansal |
| Designation |
Associate Professor |
| Affiliation |
|
| Address |
Department of ophthalmology,
govt medical college
Chandigarh
Chandigarh
CHANDIGARH
160022
India |
| Phone |
|
| Fax |
|
| Email |
bansalrk@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Drsiddharth sharma |
| Designation |
Junior Resident |
| Affiliation |
government medical college, chandigarh |
| Address |
Department of ophthalmology,
Govt medical college
Chandigarh
CHANDIGARH
160022
India |
| Phone |
|
| Fax |
|
| Email |
responsesid28@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Department of ophthalmology |
| Address |
Department of ophthalmology
govt medical college
chandigarh |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Department of ophthalmology |
G.M.C.H SECTOR 32 CHANDIGARH |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Siddharth sharma |
G.M.C.H Sector 32 A |
Department of ophthalmology
Govt medical college
Sector 32 A
Chandigarh
CHANDIGARH |
9041885690
responsesid28@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Govt medical college Chandigarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Myopia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
0.01% Atropine eye drop |
one drop of eyedrop in each eyes twice a day for 1 year |
| Comparator Agent |
0.5% Carboxymethylcellulose eye drop |
one drop of eyedrop in each eyes twice a day for 1 year |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
patient diagnosed with progressive myopia
Normal ocular health other than myopia
Informed consent
Willing to follow-up |
|
| ExclusionCriteria |
| Details |
1.allergy to atropine.
2.previous eye surgery or trauma.
3.previous use of contact lenses , bifocals or other form of treatment for myopia.
4.any cause for visual impairment other than myopia( glaucoma, cataract,Amblyopia,Strabismus )
5.Previous or concurrent use of contact lenses, bifocals, progressive addition lenses or other forms of treatment (including atropine) for myopia
6.History of cardiac , neurologic or significant respiratory diseases. Unwilling to give consent/ follow-up |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study role of Atropine 0.01% drops for controlling progression of Myopia in children |
2 weeks
3 months
6 months
9 months
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study side effects of lose dose 0.01% Atropine in children with progressive Myopia |
2 weeks
3 months
6 months
9 months
1 year |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
15/03/2018 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Myopia has emerged as a worldwide public health issue ans is 1 of the 5 ocular conditions identified as immediate priorities by the World Health Organizations’s Global Initiative for the Elimination of Avoidable Blindness. In addition to the optical impact of myopia on vision and the associated costs of correction, myopia is a major risk factor for ocular disease. Myopia increases the risk of eye diseases including glaucoma, cataract and retinal detachment.The risk of myopia are significant even in low to moderate myopes and comparable to the risks of smoking and hypertension to cardiovascular diseases.Standard of care currently treats only the optical and medical consequences of myopia rather than limiting its progression.There have been various methods in past described for control of progression of myopia.Among these methods Atropine 0.01 % have been shown to control myopia progression with minimal side effects. There have been no studies yet assessing effect of 0.01 % atropine eyedrops in Indian population for controlling myopia progression. |