Purpose

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.

Condition

Eligibility

Eligible Ages
Between 5 Years and 12 Years
Eligible Genders
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.
  • 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.

Study Design

Phase
Phase 3
Study Type
Interventional
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.
Primary Purpose
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.

Arm Groups

ArmDescriptionAssigned Intervention
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
  • Drug: Atropine
    Daily 0.01% atropine eyedrops
    Other names:
    • Low-Dose Atropine
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
  • Other: Placebo Eyedrops
    Daily placebo eyedrops

Recruiting Locations

University of Alabama at Birmingham
Birmingham, Alabama 35294
Contact:
Katherine Weise, OD, MBA
205-934-6739
kweise@uab.edu

More Details

NCT ID
NCT03334253
Status
Recruiting
Sponsor
Jaeb Center for Health Research

Study Contact

Raymond Kraker, MSPH
813-975-8690
rkraker@jaeb.org

Detailed Description

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.