Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
200 participants
INTERVENTIONAL
2018-06-01
2022-09-12
Brief Summary
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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.
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Detailed Description
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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 with myopia -1.00 to -6.00D at the time of enrollment (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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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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
Atropine
Daily 0.01% atropine eyedrops
Placebo Group
Placebo eyedrops administered 1 drop to each eye daily in each eye for 24 months, followed by 6 months off placebo eyedrops
Placebo Eyedrops
Daily placebo eyedrops
Interventions
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Atropine
Daily 0.01% atropine eyedrops
Placebo Eyedrops
Daily placebo eyedrops
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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.
5 Years
12 Years
ALL
No
Sponsors
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Pediatric Eye Disease Investigator Group
NETWORK
National Eye Institute (NEI)
NIH
Jaeb Center for Health Research
OTHER
Responsible Party
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Principal Investigators
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Michael X Repka, MD, MBA
Role: STUDY_CHAIR
Wilmer Eye Institute
Katherine K Weise, OD, MBA
Role: STUDY_CHAIR
University of Alabama Birmingham Pediatric Eye Care, Birmingham Health Care
Locations
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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
Countries
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References
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Repka MX, Weise KK, Chandler DL, Wu R, Melia BM, Manny RE, Kehler LAF, Jordan CO, Raghuram A, Summers AI, Lee KA, Petersen DB, Erzurum SA, Pang Y, Lenhart PD, Ticho BH, Beck RW, Kraker RT, Holmes JM, Cotter SA; Pediatric Eye Disease Investigator Group. Low-Dose 0.01% Atropine Eye Drops vs Placebo for Myopia Control: A Randomized Clinical Trial. JAMA Ophthalmol. 2023 Aug 1;141(8):756-765. doi: 10.1001/jamaophthalmol.2023.2855.
Weise KK, Repka MX, Zhu Y, Manny RE, Raghuram A, Chandler DL, Summers AI, Lee KA, Kehler LAF, Pang Y, Allen MS, Anderson HA, Erzurum SA, Golden RP, Koutnik CA, Kuo AF, Lenhart PD, Mokka PL, Petersen DB, Ticho BH, Wiecek EK, Yin H, Beaulieu WT, Kraker RT, Holmes JM, Cotter SA; Pediatric Eye Disease Investigator Group. Baseline factors associated with myopia progression and axial elongation over 30 months in children 5 to 12 years of age. Optom Vis Sci. 2024 Oct 1;101(10):619-626. doi: 10.1097/OPX.0000000000002187.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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MTS1
Identifier Type: -
Identifier Source: org_study_id
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