|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
12 December 2020 |
|
Main ID: |
NCT03508817 |
|
Date of registration:
|
15/04/2018 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
Atropine 0.01% Eye Drops in Myopia Study
AIMS |
|
Scientific title:
|
Randomized Clinical Trial on Atropine 0.01% for the Control of Myopia in Omani Children |
|
Date of first enrolment:
|
December 20, 2018 |
|
Target sample size:
|
150 |
|
Recruitment status: |
Enrolling by invitation |
|
URL:
|
https://clinicaltrials.gov/show/NCT03508817 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: None (Open Label).
|
|
Phase:
|
Early Phase 1
|
|
|
Countries of recruitment
|
|
Oman
| | | | | | | |
|
Contacts
|
|
Name:
|
Anuradha Ganesh, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Sultan Qaboos University |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Age: 6 to 15 years
- Myopia = 2.00 D (cycloplegic refraction; spherical equivalent)
- No prior or current treatment for preventing myopia progression (bifocals /
progressive addition lenses / orthokeratology)
Exclusion Criteria:
- Best corrected visual acuity < 0.5 (6/12)
- Refractive Myopia
- Astigmatism = 1.5 D
- Amblyopia
- Ocular hypertension / Glaucoma
- Prior intraocular surgery
- Allergy to atropine eye drops
- Systemic diseases associated with myopia such as Marfan syndrome, Stickler syndrome
- History of cardiac or significant respiratory diseases
- Lack of consent for participating in the study
Age minimum:
6 Years
Age maximum:
15 Years
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Myopia, Progressive
|
|
Intervention(s)
|
|
Drug: Atropine Sulfate 0.01% Eye Drops
|
|
Primary Outcome(s)
|
|
The primary outcome is progression of myopia
[Time Frame: 2 years]
|
|
Secondary Outcome(s)
|
|
change in axial length
[Time Frame: 2 years]
|
|
Secondary ID(s)
|
|
MREC 1473
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|