The Effects of Low Concentration Atropine on Pupil Size and Accommodation
Condition: Myopia
MeSH terms: Myopia
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine whether less frequent dosing of atropine drops may
      be as effective as daily dosing for the treatment of progressive myopia.
    

Detailed description: 
      Myopia has become an epidemic in developed countries, particularly in Asian countries and in
      the United States. Myopia, or near-sightedness, is a result of uncontrolled axial elongation
      of the eye. Besides needing optical correction in order to see clearly, myopia can result in
      many sight-threatening complications, such as retinal thinning, retinal holes and tears,
      retinal detachment, and vascular proliferation. Atropine drops have been used in clinical
      practice for over 100 years at varying concentrations and different dosing regimens. The
      proposed small study seeks to establish evidence-based treatment (dosing) guidelines for the
      use of low dose atropine for myopia control.

      The specific objectives of this study are:

        1. To assess the effects of 0.01% atropine on pupil dilation and accommodation as a measure
           of active drug levels in the eye when dosed twice per week compared to daily

        2. To assess the subjective effects of 0.01% atropine on the subjects' vision

      The study will involve one 60-minute screening session, twenty 15-minute testing sessions,
      and one 8-hour testing session, for a total of 14 hours over five to six weeks. Following the
      screening exam (information will be collected on the screening form), the subject will be
      randomly assigned to treat their non-dominant eye with:

        1. 0.01% daily dosing for two weeks followed by a 1-week washout then 0.01% twice per week
           for two weeks

        2. 0.01% twice per week dosing for two weeks, followed by a 1-week washout, then 0.01%
           daily for two weeks.

      Test sessions (expected to be no more than 15 mins in length) will be held daily during the
      testing period and scheduled at the subject's convenience. Session measurements will include
      best-corrected visual acuity, subjective amplitude of accommodation, objective amplitude of
      accommodation, and pupil size, as described previously (see screening section 7b). An
      anterior segment slit lamp biomicroscopy exam will also be performed to ensure good ocular
      health. The subject will also be asked to fill out a brief symptom questionnaire (attached)
      while they are present for the test session. Information will be recorded on the data
      collection sheet for this portion of the testing.

      Additionally, measurements of pupil size and accommodation will be taken prior to the
      instillation of a single dose of 0.01% atropine, and then at 1min, 5 min, 30 min, 1hr, 2hr,
      4hr, and 8hr post-instillation.
    

Intervention name(s): Atropine
Intervention type(s): Drug
Intervention description(s): Dosing frequency comparison, using atropine sulfate 1% solution diluted to 0.01% and 0.05% by Leiter's Compounding Pharmacy
Other intervention name(s): atropine sulfate ophthalmic solution
Intervention MeSH terms: Atropine; Ophthalmic Solutions
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Other