Low-Dose Atropine for Treatment of Myopia (MTS1)
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| ClinicalTrials.gov Identifier: NCT03334253 |
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Recruitment Status :
Completed
First Posted : November 7, 2017
Results First Posted : May 11, 2023
Last Update Posted : May 11, 2023
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Myopia | Drug: Atropine Other: Placebo Eyedrops | Phase 3 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 200 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention 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: | Triple (Participant, Investigator, Outcomes 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. |
| Primary Purpose: | Treatment |
| Official Title: | Low-Dose Atropine for Treatment of Myopia (Myopia Treatment Study) |
| Actual Study Start Date : | June 1, 2018 |
| Actual Primary Completion Date : | April 15, 2022 |
| Actual Study Completion Date : | September 12, 2022 |
| Arm | Intervention/treatment |
|---|---|
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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
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Drug: Atropine
Daily 0.01% atropine eyedrops
Other Name: Low-Dose Atropine |
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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
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Other: Placebo Eyedrops
Daily placebo eyedrops |
- Treatment Group Comparison of Change in Spherical Equivalent Refractive Error. [ Time Frame: At 24 months ]
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.
- Treatment Group Comparison of Change From Baseline to 30 Months in Spherical Equivalent [ Time Frame: At 30 months ]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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 5 Years to 12 Years (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age 5 years to <13 years at time of enrollment. Children within 4 weeks of their 13th birthday are not eligible.
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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.
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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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03334253
| United States, Alabama | |
| University of Alabama at Birmingham | |
| Birmingham, Alabama, United States, 35294 | |
| United States, Georgia | |
| The Emory Eye Center Dept of Ophthalmology | |
| Atlanta, Georgia, United States, 30322 | |
| United States, Idaho | |
| St Luke's Hospital | |
| Boise, Idaho, United States, 83702 | |
| United States, Illinois | |
| Ticho Eye Associates | |
| Chicago Ridge, Illinois, United States, 60415 | |
| Illinois College of Optometry | |
| Chicago, Illinois, United States, 60616 | |
| United States, Massachusetts | |
| Boston Children's Hospital Waltham | |
| Boston, Massachusetts, United States, 02453 | |
| United States, Ohio | |
| Pediatric Ophthalmology Associates, Inc. | |
| Columbus, Ohio, United States, 43205 | |
| Eye Care Associates, Inc. | |
| Poland, Ohio, United States, 44514 | |
| United States, Oklahoma | |
| Dean A. McGee Eye Institute, University of Oklahoma | |
| Oklahoma City, Oklahoma, United States, 73104 | |
| United States, Oregon | |
| Casey Eye Institute | |
| Portland, Oregon, United States, 97239 | |
| United States, Tennessee | |
| Vanderbilt University Medical Center - Vanderbilt Eye Institute | |
| Nashville, Tennessee, United States, 37232 | |
| United States, Texas | |
| University of Houston College of Optometry | |
| Houston, Texas, United States, 77204 | |
| United States, Utah | |
| Rocky Mountain Eye Care Associates | |
| Salt Lake City, Utah, United States, 84107 | |
| Study Chair: | Michael X Repka, MD, MBA | Wilmer Eye Institute | |
| Study Chair: | Katherine K Weise, OD, MBA | University of Alabama Birmingham Pediatric Eye Care, Birmingham Health Care |
Documents provided by Jaeb Center for Health Research:
| Responsible Party: | Jaeb Center for Health Research |
| ClinicalTrials.gov Identifier: | NCT03334253 |
| Other Study ID Numbers: |
MTS1 2U10EY011751 ( U.S. NIH Grant/Contract ) |
| First Posted: | November 7, 2017 Key Record Dates |
| Results First Posted: | May 11, 2023 |
| Last Update Posted: | May 11, 2023 |
| Last Verified: | April 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| 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. |
| Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) |
| 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. |
| Access Criteria: | Users accessing the data must enter an email address. |
| 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 |
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Myopia atropine |
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Myopia Refractive Errors Eye Diseases Atropine Ophthalmic Solutions Adjuvants, Anesthesia Anti-Arrhythmia Agents Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs |
Anti-Asthmatic Agents Respiratory System Agents Mydriatics Parasympatholytics Muscarinic Antagonists Cholinergic Antagonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmaceutical Solutions |