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Low-dose Atropine for Myopia Control in Children

NCT03865160 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 302

Last updated 2025-03-06

No results posted yet for this study

Summary

Myopia (nearsightedness) is the most common eye disorder. Only second to age, it is the main risk factor for major degenerative eye diseases such as glaucoma, macular degeneration or retinal detachment. Their risk increases with the degree of myopia. Hence, prevention of myopia and slowing its progression is of high relevance. Almost all clinical studies, including two large randomised clinical trials (RCT) were performed in Asia with Asian study participants. The results indicate that atropine eye drops can attenuate myopic progression in children, even in low concentrations thus minimizing unwanted side effects. However, the cumulative evidence is yet not strong enough to recommend their unrestricted use, especially in a Non-Asian population. We therefore intend to set up an adequately powered RCT comparing atropine 0.02% eye drops with placebo to validate previous findings and to test whether this therapeutic concept holds its promise in a European population.

Conditions

  • Myopia, Progressive

Interventions

DRUG

Atropine eye drops, 0.01%

One drop of the above mentioned drug will be installed into each eye daily at bedtime.

DRUG

Atropine eye drops, 0.02%

One drop of the above mentioned drug will be installed into each eye daily at bedtime.

DRUG

Placebo (NaCl 0.9%) eye drops

One drop of the above mentioned drug will be installed into each eye daily at bedtime.

Sponsors & Collaborators

  • University Eye Hospital, Freiburg

    lead OTHER

Principal Investigators

  • Wolf Lagrèze, Prof. · Eye Center, Medical Center, University Hospital Freiburg

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
8 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-19
Primary Completion
2025-11-30
Completion
2027-11-30

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03865160 on ClinicalTrials.gov