| CTRI Number |
CTRI/2016/11/007450 [Registered on: 08/11/2016] Trial Registered Prospectively |
| Last Modified On: |
07/11/2016 |
| Post Graduate Thesis |
No |
| 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
|
A randomized controlled trial to evaluate the effect of low dose atropine eyedrop for childhood myopia |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rohit Saxena |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Room 377 Third floor Dr RP Centre AIIMS
New Delhi
DELHI
110029
India |
| Phone |
|
| Fax |
|
| Email |
rohitsaxena80@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Rohit Saxena |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Room 377 Third floor Dr RP Centre AIIMS
New Delhi
DELHI
110029
India |
| Phone |
|
| Fax |
|
| Email |
rohitsaxena80@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Rohit Agarwal |
| Designation |
Senior Resident |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Room 377 Third floor Dr RP Centre AIIMS
Room 377 Third floor Dr RP Centre AIIMS
New Delhi
DELHI
110029
India |
| Phone |
1126593182 |
| Fax |
01126593182 |
| Email |
drrohit87@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Rajendra Prasad Centre for Ophthalmic Science |
| Address |
Dr Rajendra Prasad Centre for Ophthalmic Sciences , AIIMS,New Delhi-110029 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Rohit Saxena |
Dr RP Centre |
Room 377 Third floor Dr RP Centre for Ophthalmic Sciences All India Institute of Medical Sciences
New Delhi
DELHI |
1126593182
1126593182
rohitsaxena80@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Commitee All India Institute of medical Sciences |
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 once at night for 1 year |
| Comparator Agent |
0.5% Carboxymethylcellulose eye drop |
one drop of eyedrop in each eyes once at night for 1 year |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Age 6-12 years
Refractive error of spherical equivalent between -2D to -6D in each eye as measured by cycloplegic autorefraction
Distance vision correctable to logMAR 0.2 or better in both eyes
Normal ocular health other than myopia
Informed consent
Willing to follow-up
|
|
| ExclusionCriteria |
| Details |
Astigmatism more than -1.5 D as measured by cycloplegic autorefraction
Amblyopia
Strabismus
Allergy to atropine or homatropine
Previous or concurrent use of contact lenses, bifocals, progressive addition lenses or other forms of treatment (including atropine) for myopia
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 |
| myopia progression |
2 weeks
2 months
4 months
8 months
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| side effects |
2 weeks
2 months
4 months
8 months
1 year |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/12/2016 |
| Date of Study Completion (India) |
Date Missing |
| 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)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NA |
|
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. |