| CTRI Number |
CTRI/2019/09/021193 [Registered on: 12/09/2019] Trial Registered Prospectively |
| Last Modified On: |
10/09/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Low dose Atropine for Myopia control |
|
Scientific Title of Study
|
COMPARATIVE STUDY OF MYOPIA PROGRESSION IN SUBJECTS ON LOW DOSAGE OF
ATROPINE WITH MATCHED CONTROLS OF DIFFERENT AGE GROUPS |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sumit Monga |
| Designation |
Senior Consultant, Pediatric and Neuro-Ophthalmology Service |
| Affiliation |
Centre for Sight |
| Address |
Centre for Sight Eye Institute,
Pediatric wing, Second floor,
Plot No. 9, Sector 9, Dwarka, Delhi
Centre for Sight,
B5/24, Safdarjang Enclave, Delhi.
South
DELHI
110075
India |
| Phone |
01142504250 |
| Fax |
|
| Email |
drsumitmonga@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sumit Monga |
| Designation |
Senior Consultant, Pediatric and Neuro-ophthalmology Service |
| Affiliation |
Centre for Sight |
| Address |
Centre for Sight Eye Institute, Pediatric Wing,
Plot No. 9, Sector 9, Dwarka, Delhi
Centre for Sight,
B5/24,
Safdarjang Enclave, Delhi
South
DELHI
110075
India |
| Phone |
01142504250 |
| Fax |
|
| Email |
drsumitmonga@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sumit Monga |
| Designation |
Senior Consultant, Pediatric and Neuro-ophthalmology Service |
| Affiliation |
Centre for Sight |
| Address |
Centre for Sight Eye Institute,
Pediatric Wing, Second floor,
Plot No.9, Sector 9, Dwarka
Centre for Sight,
B5/24, Safdarjang Encalve,Delhi
South
DELHI
110075
India |
| Phone |
01142504250 |
| Fax |
|
| Email |
drsumitmonga@gmail.com |
|
|
Source of Monetary or Material Support
|
| Centre for Sight Eye Institute, Dwarka (Institution itself) |
|
|
Primary Sponsor
|
| Name |
Centre for Sight |
| Address |
B5/24, Safdarjang Enclave, Delhi. |
| 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 |
| Dr Nayak |
Centre for Sight Eye Institute |
Plot No.9 Sector 9 Dwarka
South West
DELHI |
01142504250
ms@centreforsight.net |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Centre for Sight Institutional Ethics Committee (CFS IMEC) |
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 |
Low dose atropine eyedrops (0.01%) |
Topical instillation of low dose atropine eyedrops in both eyes at night time, daily, alongwith glass use (one eyedop in each eye, once daily dosage would be given for 2 years duration)(Intervention group) and No drops (only glasses) in control group |
| Comparator Agent |
Not Applicable |
Only Glasses |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
1. Age: 6 to 18 years
2. Myopia ≥ 2.00 D (cycloplegic refraction; spherical equivalent) with or
without any astigmatism
3. The minimum increase in refractive error should be 0.75DS in less
than 6 months.
4. Provide written informed consent;
5. No prior or current treatment for preventing myopia progression
(bifocals / progressive addition lenses / orthokeratology)
6. Willingness and ability to follow all instructions and comply with
schedule for follow-up visits |
|
| ExclusionCriteria |
| Details |
1. Best corrected visual acuity < 6/18
2. Simple myopic/hyperopic astigmatism with 0 spherical refractive error (Pure astigmatism)
3. No prior or current treatment for preventing myopia progression (bifocals / progressive addition lenses / orthokeratology)
4. Ocular diseases like Retinal dystrophy, Retinopathy of prematurity, Corneal opacities, keratoconus, Ocular hypertension / Glaucoma
5. Prior intraocular surgery
6. Allergy to atropine eye drops
7. Lack of consent for participating in the study
8. Systemic diseases associated with myopia such as Marfan syndrome, Stickler syndrome, Down syndrome, cardiac or significant respiratory diseases
9. Those lost to follow-ups, lack of 80% compliance to Atropine 0.01% eyedrops
10. In addition, the Investigator may exclude or discontinue any subject for any sound medical reason. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Change in spherical equivalent refractive error (SER) relative to baseline (Indicator of progression of myopia)
2. Change in axial length during follow-up relative to baseline (Increased axial length correlates with myopic progression).
|
2years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Any adverse events (blurred near vision, glare, allergic reaction, if any) |
2 years |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
12/09/2019 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Control of myopia progression has become an important goal, as myopia is a leading cause of visual disability throughout the world. In India uncorrected refractive errors are one of the most common causes of visual impairment. Currently, on average, 30% of the world is myopic and by 2050, based on current trends, almost 50% will be myopic, that’s 5 billion people.High Myopia may be associated with significantly increased risks of retinal degeneration, retinal detachment, glaucoma and cataract associated with high myopia. Several methods including use of progressive addition lenses, rigid gas-permeable contact lenses, and life-style modifications (increased outdoor activity) have reported to alter myopia progression with varying efficacy. In general they have yielded clinical results of marginal significance. Atropine sulphate eye drops (1%) has consistently been demonstrated to inhibit axial myopia progression in both humans and animal models. Yet, it has not found widespread clinical application for myopia control due to ocular side-effects of cycloplegia and pupil dilation. Recently, 0.01% atropine has been shown to be effective in arresting myopia progression without side-effects of cycloplegia and near vision impairment and pupil dilation and increased light sensitivity. However, almost all studies on atropine have been carried out on children of Chinese origin (SE Asia). Efficacy (concentration and dosing)and safety need to be established in the population of interest, before routine use can be recommended. We plan to evaluate the efficacy and safety of topical atropine eye drops(0.01%) in slowing the progression of myopia and ocular axial elongation in Indian children. A total of 80 children of
ages 6-18 years will be classified into two groups based on age, which will further be randomized into two sub groups. Intervention subgroup for each age group will receive atropine 0.01% once daily in each eye. Control group will not receive any medications. Follow up visits will be scheduled every six months The progression of myopia (change in refractive error and axial length) will be compared in the two groups by objective methods. It will alsobe compared on different grades of myopia and different age groups to state the best time to start myopia control.
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