N/A N=71 Randomized Double-blind Prevention

Topical Application of Low-concentration (0.01%) Atropine on the Human Eye With Fast and Slow Myopia Progression Rate

Myopia

Bottom Line

View on ClinicalTrials.gov: NCT03374306 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Oct 2024

Primary outcome: Primary: Annualized Changes in Refractive Error (SER) — -0.70; -0.66 Dioptre/year

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Atropine (0.01%) (Drug); Artificial tear (Drug)
Age: Pediatric · 7+ yrs
Sex: All
Sponsor: The Hong Kong Polytechnic University
Primary completion: Dec 2019

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	—

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.

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

View full record on ClinicalTrials.gov →

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.