Low-Dose Atropine for Treatment of Myopia

Jaeb Center for Health Research200 enrolled

Overview

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.

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 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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Eligibility

Sex: ALLMin age: 5 YearsMax age: 12 Years

Medical Language ↔ Plain English

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.

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

...and 3 more locations

Outcomes

Primary Outcomes

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.

Time frame: At 24 months

Primary Outcome Measure Stratified by Sex

NIH-required analysis. Primary outcome measure (stratified by sex): 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

Primary Outcome Measure Stratified by Race

NIH-required analysis. Primary outcome measure (stratified by race): 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: by 24 months

Primary Outcome Measure Stratified by Ethnicity

NIH-required analysis. Primary outcome measure (stratified by ethnicity): 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

Primary Outcome: Mean Change in Spherical Equivalent Refractive Error at 24 Months

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.

Time frame: 24 months

Secondary Outcomes

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.

Time frame: At 30 months