Low-Dose Atropine for Treatment of Myopia
Condition: Myopia
MeSH terms: Myopia
Intervention: Atropine; Placebo Eyedrops
Intervention description: Daily 0.01% atropine eyedrops; Daily placebo eyedrops
Intervention MeSH terms: Atropine; Ophthalmic Solutions
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
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.
Enrollment: 200.0
Sex: All
Minimum age: 5 Years
Maximum age: 12 Years
Healthy volunteers: No
Keywords: Myopia; atropine

Summary:

      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.
    

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.