Low-Dose Atropine for Treatment of Myopia (Myopia Treatment Study)

Who is this study for? Patients with myopia
What treatments are being studied? Atropine
Status: Completed
Location: See all (13) locations...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

Study Objectives The objectives for this randomized trial are: To determine the efficacy of daily low-dose atropine (0.01%) for slowing myopia progression over a two-year treatment period in children aged 5 to less than 13 years (Primary Outcome On-Treatment). To determine the efficacy of atropine treatment on myopia progression 6 months following cessation of low-dose atropine treatment (Secondary Outcome Off-Treatment). Synopsis of Study Design The current study is designed as an efficacy study, making effort to maximize adherence to treatment group assignments. After a run-in phase during which all participants are treated with daily artificial tear eyedrops for 2-4 weeks (and glasses are updated if required) to assess their ability to adhere to daily eye drops, participants are randomly assigned to daily atropine or placebo for 24 months, followed by 6 months off treatment.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 5
Maximum Age: 12
Healthy Volunteers: No
View:

• 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.

Locations
United States
Alabama
University of Alabama at Birmingham
Birmingham
Georgia
The Emory Eye Center Dept of Ophthalmology
Atlanta
Idaho
St Luke's Hospital
Boise
Illinois
Illinois College of Optometry
Chicago
Ticho Eye Associates
Chicago Ridge
Massachusetts
Boston Children's Hospital Waltham
Boston
Ohio
Pediatric Ophthalmology Associates, Inc.
Columbus
Eye Care Associates, Inc.
Poland
Oklahoma
Dean A. McGee Eye Institute, University of Oklahoma
Oklahoma City
Oregon
Casey Eye Institute
Portland
Tennessee
Vanderbilt University Medical Center - Vanderbilt Eye Institute
Nashville
Texas
University of Houston College of Optometry
Houston
Utah
Rocky Mountain Eye Care Associates
Salt Lake City
Time Frame
Start Date: June 1, 2018
Completion Date: September 12, 2022
Participants
Target number of participants: 187
Treatments
Experimental: Atropine Group
0.01% atropine eyedrops administered 1 drop to each eye daily in each eye for 24 months, followed by 6 months off atropine eyedrops
Placebo Comparator: Placebo Group
Placebo eyedrops administered 1 drop to each eye daily in each eye for 24 months, followed by 6 months off placebo eyedrops
Authors
David Petersen
Related Therapeutic Areas
Sponsors
Collaborators: National Eye Institute (NEI), Pediatric Eye Disease Investigator Group
Leads: Jaeb Center for Health Research

This content was sourced from clinicaltrials.gov

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