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NCT03374306 Clinical Trial

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

Myopia Clinical Trial

Official title:
Treatment Effect of Topical Application of Low-concentration (0.01%) Atropine on the Human Eye With Fast and Slow Myopia Progression Rate as Classified by Electro-retinal Responses

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03374306
Other study ID # HongKongPU_Optometry1
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2018
Est. completion date August 31, 2020

Study information
Verified date August 2021
Source The Hong Kong Polytechnic University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 56
Est. completion date August 31, 2020
Est. primary completion date December 31, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 7 Years to 10 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Atropine (0.01%)
tropical application
• Artificial tear
tropical application

Locations
Country Name City State
Hong Kong School of Optometry, Hong Kong Polytechnic University Hong Kong

Sponsors (2)
Lead Sponsor Collaborator
The Hong Kong Polytechnic University The University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome
Type Measure Description Time frame Safety issue
Primary Refractive errors Refractive errors up to 18 months
Secondary Axial length Size of the eyeball up to 18 months
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