Status:
COMPLETED
Low-Dose Atropine for Treatment of Myopia
Lead Sponsor:
Jaeb Center for Health Research
Collaborating Sponsors:
Pediatric Eye Disease Investigator Group
National Eye Institute (NEI)
Conditions:
Myopia
Eligibility:
All Genders
5-12 years
Phase:
PHASE3
Brief Summary
Study Objectives The objectives for this randomized trial are: 1. To determine the efficacy of daily low-dose atropine (0.01%) for slowing myopia progression over a two-year treatment period in chil...
Detailed Description
Study Objectives The objectives for this randomized trial are: 1. To determine the efficacy of daily low-dose atropine (0.01%) for slowing myopia progression over a two-year treatment period in chil...
Eligibility Criteria
Inclusion
- Age 5 years to \<13 years at time of enrollment. Children within 4 weeks of their 13th birthday are not eligible.
- Refractive error meeting the following by cycloplegic autorefraction:
- Myopia -1.00D to -6.00D spherical equivalent (SE) in both eyes
- Astigmatism \<=1.50D in both eyes
- Anisometropia \<1.00D SE
- Gestational age ≥ 32 weeks.
- Birth weight \>1500g.
- Parent understands the protocol and is willing to accept randomization to atropine or placebo.
- Is willing to participate in a 2 to 4 week run-in phase using daily artificial tear eyedrops.
- Able to return in 2 to 4 weeks for possible randomization.
- Parent has a phone (or access to phone) and is willing to be contacted by Investigator's site staff.
- Relocation outside of the area of an active PEDIG site within next 32 months is not anticipated.
Exclusion
- Current or previous myopia treatment with atropine, pirenzepine or other anti-muscarinic agent.
- Current or previous use of bifocals, progressive-addition lenses, or multi-focal contact lenses.
- Current or previous use of orthoK, rigid gas permeable, or other contact lenses being used to reduce myopia progression.
- Known atropine allergy.
- Abnormality of the cornea, lens, central retina, iris or ciliary body.
- Current or prior history of manifest strabismus, amblyopia, or nystagmus.
- Prior eyelid, strabismus, intraocular, or refractive surgery.
- Down syndrome or cerebral palsy.
- Females who are pregnant, lactating, or intending to become pregnant within the next 30 months.
- A negative urine pregnancy test will be required for all females who have experienced menarche.
Key Trial Info
Start Date :
June 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 12 2022
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT03334253
Start Date
June 1 2018
End Date
September 12 2022
Last Update
September 5 2023
Active Locations (13)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
2
The Emory Eye Center Dept of Ophthalmology
Atlanta, Georgia, United States, 30322
3
St Luke's Hospital
Boise, Idaho, United States, 83702
4
Illinois College of Optometry
Chicago, Illinois, United States, 60616