Comparing low and high doses of Atropine for treating progressive myopia in children
Investigator Led, Double-masked, Multicenter, Randomized Clinical Trial for the Comparison of Atropine 0.5% Versus Atropine 0.05% Eye Drops for the Prevention of Myopia Progression in Dutch Children
This study is testing whether low-dose Atropine eye drops can slow down worsening eyesight in children with progressive myopia better than high-dose Atropine.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 550 (estimated) |
| Ages | 6 Years to 11 Years |
| Sex | All |
| Sponsor | Erasmus Medical Center Academic / other |
| Locations | 20 sites (Almere Stad and 19 other locations) |
| Trial ID | NCT05667454 on ClinicalTrials.gov |
What this trial studies
This interventional study aims to evaluate the effectiveness of Atropine 0.05% compared to Atropine 0.5% in slowing the progression of axial length in children aged 6 to 11 years with progressive myopia. Over a period of three years, participants will use Atropine eye drops, followed by a two-year observational phase to assess safety, adherence, and reasons for nonresponse. The study addresses the increasing prevalence of high myopia and its associated risks, focusing on pharmacological interventions to prevent excessive eye growth in childhood.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 6 to 11 years with a history of progressive myopia and specific refractive error measurements.
Not a fit: Patients with allergies to atropine, history of amblyopia or strabismus, or other significant ocular or systemic disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a safer and effective treatment option for children with progressive myopia, potentially reducing the risk of severe vision complications later in life.
How similar studies have performed: While many ongoing trials are comparing various low doses of Atropine to placebo, this study's direct comparison of the highest low dose to the lowest high dose is a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Children aged 6 to ≤ 11 years with bilateral myopia * Onset of myopia ≥ 4 years of age * History of progression * SER of at least -1.00D and no greater than -6.00D in each eye measured using cycloplegic auto refraction * Intraocular pressure \< 21 mm Hg in each eye * Distance vision correctable to at least 0.1 Log MAR (logarithm of the minimum angle of resolution) in each eye Exclusion Criteria: * Allergy to atropine or other excipients of the eye drops * History of amblyopia or strabismus * History of retinal dystrophy or systemic disorder * Abnormal ocular biometry aside from axial length * History of glaucoma * Chronic use of topical or systemic antimuscarinic/anticholinergic medications in the 21 days prior to screening, and/or anticipated need for chronic use over the duration of the study (i.e., more than 7 consecutive days in 1 month or more than a total of 30 days in 1 year). * Chronic use (more than 3 days a week) of topical ophthalmological medication (prescribed or over the counter) other than the assigned study medication. The use of artificial tears is allowed but not in the 1 hour before or after the administration of the study medication. * The anticipated need to use chronic ophthalmic or systemic oral corticosteroids during the study. (i.e., \< 2 weeks) * Prior myopia treatments. * Employees of the study center and their family members.
Where this trial is running
Almere Stad and 19 other locations
- Flevoziekenhuis — Almere Stad, Netherlands (Recruiting)
- OLVG, locatie Oost — Amsterdam, Netherlands (Recruiting)
- Ophthalmologistenpraktijk Delfland — Delft, Netherlands (Recruiting)
- Reinier de Graaf Gasthuis — Delft, Netherlands (Recruiting)
- Deventer Ziekenhuis — Deventer, Netherlands (Recruiting)
- Albert Schweitzer ziekenhuis — Dordrecht, Netherlands (Recruiting)
- Bergman Clinics - Ede — Ede, Netherlands (Recruiting)
- Admiraal de Ruyter Ziekenhuis — Goes, Netherlands (Recruiting)
- Frisius MC — Heerenveen, Netherlands (Recruiting)
- Oogcentrum Noordholland — Heerhugowaard, Netherlands (Recruiting)
- Leiden University Medical Center — Leiden, Netherlands (Recruiting)
- Bergman Clinics - Lelystad — Lelystad, Netherlands (Recruiting)
- Maastricht UMC+ — Maastricht, Netherlands (Recruiting)
- St. Antonius — Nieuwegein, Netherlands (Recruiting)
- Radboudumc — Nijmegen, Netherlands (Recruiting)
- Erasmus Medical Center — Rotterdam, Netherlands (Recruiting)
- Haga Ziekenhuis — The Hague, Netherlands (Recruiting)
- Oogkliniek Den Haag — The Hague, Netherlands (Recruiting)
- Ziekenhuis Rivierenland Tiel — Tiel, Netherlands (Recruiting)
- Elisabeth-TweeSteden Ziekenhuis — Tilburg, Netherlands (Recruiting)
Study contacts
- Principal investigator: C.C.W. Klaver, Prof. Dr. — Emc
- Study coordinator: Jan Roelof Polling, Dr.
- Email: j.polling@erasmusmc.nl
- Phone: +31628449254
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.