Spectacles or Atropine for Myopia Control

A RCT of Spectacles With Aspherical Lenslets or 0.05% Atropine for Myopia Control

Recruiting Phase 3 Interventional Study
Myopia
Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
5 – 11
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
348 (estimated)
Sponsor
Jaeb Center for Health Research · Other
Who this trial is looking for

This trial is looking for children aged 5 to 11 years who have myopia, which is nearsightedness. Participants will use either special glasses or eye drops each night for treatment and will be monitored for 2 years.

Are You a Good Fit for This Trial?
Rules you out Down syndromeCerebral palsyAmblyopiaNystagmus

You may be able to join if

  • I am between 5 and 11 years old.
  • I have myopia between 0.75D and 6.00D.
  • I have normal vision in both eyes for my age.
  • I wear spectacles for most of my waking hours.
  • I have a birth weight over 1500 grams.
  • I understand the study procedures and agree to join.
  • I can come back for follow-up visits.
  • I am willing to stop wearing contact lenses during the study.

You may not be able to join if

  • I have used any treatment for myopia in the past.
  • I have worn contact lenses for more than 7 days in the past year.
  • I have allergies to atropine or shellfish.
  • I have any significant eye problems.
  • I have had any eye surgery before.
  • I have certain medical conditions affecting eye health.
  • I am pregnant, breastfeeding, or plan to become pregnant soon.
  • I have a family member involved in this study.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial
To date, randomized trials of low-concentration atropine eyedrops and specially designed spectacle lenses to slow the progression of myopia are limited in number and results are inconsistent in non-Asian children. Although results of some recent randomized clinical trials outside the US are promising, additional studies in children are needed to test the safety and efficacy of low-concentration a…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Age 5 years to \<12 years at time of enrollment. Children within 4 weeks of their 12th birthday are not eligible. 2. Refractive error meeting the following by cycloplegic autorefraction: * Myopia of 0.75D to 6.00D SER and at least 0.75D in both principal meridians of each…
Contacts

Raymond T Kraker, MSPH

813-975-8690

rkraker@jaeb.org

CONTACT

Courtney L Conner

813-975-8690

cconner@jaeb.org

CONTACT