N/A
Completed N=71
Topical Application of Low-concentration (0.01%) Atropine on the Human Eye With Fast and Slow Myopia Progression Rate
Source: ClinicalTrials.gov NCT03374306 ↗Enrolled (actual)
71
Serious AEs
0.0%
Results posted
Oct 2024
Primary outcomePrimary: Annualized Changes in Refractive Error (SER) — -0.70; -0.66 Dioptre/year
Summary
Our project is a 24-month longitudinal randomized controlled trial that aims to investigate the myopia development after topical application of 0.01% atropine in children with either fast or slow myopia progression classified according to their initial electro-retinal responses. This will help elucidate the effectiveness of using low concentration atropine for myopia control in children with different myopia progression rates.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Annualized Changes in Refractive Error (SER) |
-0.70; -0.66 | — |
| SECONDARY Annualized Change in Axial Length |
0.3; 0.32 | — |
Eligibility Criteria
Inclusion Criteria
- Age between 7 and 10 years
- Good general health and no family history of ocular diseases
- No current or history of epilepsy or asthma
- Myopia : -0.50 to -1.00 D (inclusive, both eyes)
- Astigmatism : ≤ 0.50 D
- No hyperopia, amblyopia or strabismus
- No reported ocular eye diseases or disorders
- No drug allergy
Data sourced from ClinicalTrials.gov (NCT03374306). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.