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Childhood Atropine for Myopia Progression (CHAMPStudy

 

Berkeley is excited to be a site in the Childhood Atropine for Myopia Progression (CHAMPStudy. This is an industry-sponsored, multi-center, double-blind, 3-arm randomized controlled trial testing the safety and efficacy of 0.01% atropine sulfate and 0.02% atropine sulfate against a placebo (vehicle) control. The clinicaltrials.gov listing for the study is linked here.
 
We have listed some important details below (study website linked here). If you think that you may qualify or would like to find out more information, please reach out! We can be reached at champstudy.This email address is being protected from spambots. You need JavaScript enabled to view it. or leave us a voicemail at (510)883-3190.


Study
 Information

 
Duration 
48 months (4 years). Participants will spend 36 months on one of three possible treatments (0.01% atropine, 0.02% atropine, or vehicle control), then they are re-randomized to another treatment in the final year. Those who were on placebo for the first three years are guaranteed to be placed in a treatment arm for the final year of the study.
 
Randomization
Participants will be randomly assigned to a treatment group or a placebo treatment. The doctors and the patients are masked to the treatment assignment.
 
Eligibility
We are looking to recruit subjects primarily in the age range of 6-10 years of age (although participants over the age of 3 are permitted as long as they are able to cooperate fully for the required study testing).
 
Inclusion Criteria
  • Myopia between -0.50D and -6.00D (SER) in both eyes
  • Astigmatism less than 1.75DC
  • Anisometropia less than 1.50D
Exclusion Criteria
  • Any current (or any history of) amblyopia or strabismus
  • History of any disease or syndrome that predisposes the participant to high myopia (e.g. Stickler Syndrome, ROP)
  • Any abnormal ocular refractive anatomy (e.g. keratoconus)
  • Any serious systemic illness
  • Chronic use (defined as more than three times per week) of any topical ophthalmic drug other than the study medication.
  • Any current (or history of) myopia control treatment (e.g. orthokeratology, multifocal lenses, atropine, bifocal spectacle lenses). Single vision soft contact lenses and single vision spectacle lenses are the only acceptable forms of refractive correction for the duration of the trial.
Benefits
The greatest benefit to participants is being able to assist in our understanding of myopia management and influence the future of pediatric eye care. To show our appreciation for participating in this important research, all study-related eye care visits will be paid for by the sponsor, and participants will also receive an annual reimbursement for glasses or contact lenses.
 
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