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COMPLETED
NCT03334253
PHASE3

Low-Dose Atropine for Treatment of Myopia

Sponsor: Jaeb Center for Health Research

View on ClinicalTrials.gov

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 children aged 5 to less than 13 years (Primary Outcome On-Treatment). 2. 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.

Official title: Low-Dose Atropine for Treatment of Myopia (Myopia Treatment Study)

Key Details

Gender

All

Age Range

5 Years - 12 Years

Study Type

INTERVENTIONAL

Enrollment

200

Start Date

2018-06-01

Completion Date

2022-09-12

Last Updated

2026-07-09

Healthy Volunteers

No

Conditions

Interventions

DRUG

Atropine

Daily 0.01% atropine eyedrops

OTHER

Placebo Eyedrops

Daily placebo eyedrops

Locations (13)

University of Alabama at Birmingham

Birmingham, Alabama, United States

The Emory Eye Center Dept of Ophthalmology

Atlanta, Georgia, United States

St Luke's Hospital

Boise, Idaho, United States

Illinois College of Optometry

Chicago, Illinois, United States

Ticho Eye Associates

Chicago Ridge, Illinois, United States

Boston Children's Hospital Waltham

Boston, Massachusetts, United States

Pediatric Ophthalmology Associates, Inc.

Columbus, Ohio, United States

Eye Care Associates, Inc.

Poland, Ohio, United States

Dean A. McGee Eye Institute, University of Oklahoma

Oklahoma City, Oklahoma, United States

Casey Eye Institute

Portland, Oregon, United States

Vanderbilt University Medical Center - Vanderbilt Eye Institute

Nashville, Tennessee, United States

University of Houston College of Optometry

Houston, Texas, United States

Rocky Mountain Eye Care Associates

Salt Lake City, Utah, United States