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

Not Applicable

Completed

• Conditions: Myopia
• Interventions: Drug: Artificial tear; Drug: Atropine (0.01%)

• Registration Number: NCT03374306
• Lead Sponsor: The Hong Kong Polytechnic University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-12-11
• Study First Submitted QC: 2017-12-11
• Study First Posted: 2017-12-15
• Study Start: 2018-02-01
• Primary Completion: 2019-12-31
• Study Completion: 2020-08-31
• Results First Submitted: 2023-02-27
• Status Verified: 2024-10
• Results First Submitted QC: 2024-10-10
• Last Update Submitted: 2024-10-10
• Results First Posted: 2024-10-16
• Last Update Posted: 2024-10-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 71

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Artifical tear	Artificial tear	Group receiving placebo for 18 months
Atropine 0.01%	Atropine (0.01%)	Group receiving atropine treatment for 18 months

Primary Outcome Measures

Name	Time	Method
Annualized Changes in Refractive Error (SER)	18 months	Annualized changes in refractive error (SER) after receiving the 0.01 atropine or artificial tears up to 18 months

Secondary Outcome Measures

Name	Time	Method
Annualized Change in Axial Length	18 months	Annualized change in axial length after receiving the 0.01 atropine or artificial tears up to 18 months

Trial Locations

Locations (1)

School of Optometry, Hong Kong Polytechnic University; 🇭🇰 Hong Kong, Hong Kong