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Low-Dose Atropine for Treatment of Myopia (MTS1)

Primary Purpose

Myopia

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Atropine
Placebo Eyedrops
Sponsored by
Jaeb Center for Health Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myopia focused on measuring Myopia, atropine

Eligibility Criteria

5 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Sites / Locations

  • University of Alabama at Birmingham
  • The Emory Eye Center Dept of Ophthalmology
  • St Luke's Hospital
  • Ticho Eye Associates
  • Illinois College of Optometry
  • Boston Children's Hospital Waltham
  • Pediatric Ophthalmology Associates, Inc.
  • Eye Care Associates, Inc.
  • Dean A. McGee Eye Institute, University of Oklahoma
  • Casey Eye Institute
  • Vanderbilt University Medical Center - Vanderbilt Eye Institute
  • University of Houston College of Optometry
  • Rocky Mountain Eye Care Associates

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Atropine Group

Placebo Group

Arm Description

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 eyedrops administered 1 drop to each eye daily in each eye for 24 months, followed by 6 months off placebo eyedrops

Outcomes

Primary Outcome Measures

Treatment Group Comparison of Change in Spherical Equivalent Refractive Error.
The primary analysis will be a treatment group comparison of change from baseline to 24-months in spherical equivalent refractive error (SER), as measured by a masked examiner using cycloplegic autorefraction (on-treatment comparison). The mean of the three readings from autorefraction in each eye will be calculated and then the mean of both eyes for each participant will be used for the analysis. The treatment group difference (atropine - placebo) and a 95% confidence interval will be calculated based on the model estimates at 24 months.

Secondary Outcome Measures

Treatment Group Comparison of Change From Baseline to 30 Months in Spherical Equivalent
Treatment group comparison of change from baseline to 30 months in spherical equivalent in each eye as measured by a masked examiner using cycloplegic autorefraction (off-treatment comparison). Calculated based on the model estimates at 24 months.

Full Information

First Posted
November 2, 2017
Last Updated
August 22, 2023
Sponsor
Jaeb Center for Health Research
Collaborators
Pediatric Eye Disease Investigator Group, National Eye Institute (NEI)
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1. Study Identification

Unique Protocol Identification Number
NCT03334253
Brief Title
Low-Dose Atropine for Treatment of Myopia
Acronym
MTS1
Official Title
Low-Dose Atropine for Treatment of Myopia (Myopia Treatment Study)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
June 1, 2018 (Actual)
Primary Completion Date
April 15, 2022 (Actual)
Study Completion Date
September 12, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jaeb Center for Health Research
Collaborators
Pediatric Eye Disease Investigator Group, National Eye Institute (NEI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed Description
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 with myopia -1.00 to -6.00D at the time of enrollment (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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia
Keywords
Myopia, atropine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
Cycloplegic autorefraction, axial length, and additional biometry will be measured by a masked examiner at all follow-up visits using the same instrumentation on the participant throughout the study. Masking will be accomplished by having site personnel administer cyclopentolate to both eyes of each participant and wait 30 minutes before he/she sees the masked examiner. The masked examiner may be a technician or an investigator and must be certified to complete these measurements. Parents, patients, and investigators are also masked to treatment.
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Atropine Group
Arm Type
Experimental
Arm Description
0.01% atropine eyedrops administered 1 drop to each eye daily in each eye for 24 months, followed by 6 months off atropine eyedrops
Arm Title
Placebo Group
Arm Type
Placebo Comparator
Arm Description
Placebo eyedrops administered 1 drop to each eye daily in each eye for 24 months, followed by 6 months off placebo eyedrops
Intervention Type
Drug
Intervention Name(s)
Atropine
Other Intervention Name(s)
Low-Dose Atropine
Intervention Description
Daily 0.01% atropine eyedrops
Intervention Type
Other
Intervention Name(s)
Placebo Eyedrops
Intervention Description
Daily placebo eyedrops
Primary Outcome Measure Information:
Title
Treatment Group Comparison of Change in Spherical Equivalent Refractive Error.
Description
The primary analysis will be a treatment group comparison of change from baseline to 24-months in spherical equivalent refractive error (SER), as measured by a masked examiner using cycloplegic autorefraction (on-treatment comparison). The mean of the three readings from autorefraction in each eye will be calculated and then the mean of both eyes for each participant will be used for the analysis. The treatment group difference (atropine - placebo) and a 95% confidence interval will be calculated based on the model estimates at 24 months.
Time Frame
At 24 months
Secondary Outcome Measure Information:
Title
Treatment Group Comparison of Change From Baseline to 30 Months in Spherical Equivalent
Description
Treatment group comparison of change from baseline to 30 months in spherical equivalent in each eye as measured by a masked examiner using cycloplegic autorefraction (off-treatment comparison). Calculated based on the model estimates at 24 months.
Time Frame
At 30 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael X Repka, MD, MBA
Organizational Affiliation
Wilmer Eye Institute
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Katherine K Weise, OD, MBA
Organizational Affiliation
University of Alabama Birmingham Pediatric Eye Care, Birmingham Health Care
Official's Role
Study Chair
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
The Emory Eye Center Dept of Ophthalmology
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
St Luke's Hospital
City
Boise
State/Province
Idaho
ZIP/Postal Code
83702
Country
United States
Facility Name
Ticho Eye Associates
City
Chicago Ridge
State/Province
Illinois
ZIP/Postal Code
60415
Country
United States
Facility Name
Illinois College of Optometry
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60616
Country
United States
Facility Name
Boston Children's Hospital Waltham
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02453
Country
United States
Facility Name
Pediatric Ophthalmology Associates, Inc.
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205
Country
United States
Facility Name
Eye Care Associates, Inc.
City
Poland
State/Province
Ohio
ZIP/Postal Code
44514
Country
United States
Facility Name
Dean A. McGee Eye Institute, University of Oklahoma
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Casey Eye Institute
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Vanderbilt University Medical Center - Vanderbilt Eye Institute
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
University of Houston College of Optometry
City
Houston
State/Province
Texas
ZIP/Postal Code
77204
Country
United States
Facility Name
Rocky Mountain Eye Care Associates
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
In accordance with the NIH data sharing policy, a de-identified database is placed in the public domain on the PEDIG public website after the completion of each protocol and publication of the primary manuscript.
IPD Sharing Time Frame
After completion of the protocol and publication of the primary manuscript, the data will be made available for the duration of the grant and any future grants.
IPD Sharing Access Criteria
Users accessing the data must enter an email address.
Citations:
PubMed Identifier
37440213
Citation
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.
Results Reference
result

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Low-Dose Atropine for Treatment of Myopia

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