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

NCT ID: NCT03374306

Last Updated: 2024-10-16

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

71 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-01

Study Completion Date

2020-08-31

Brief Summary

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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

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Conditions

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Myopia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized clinical trial
Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators
Double-blinded

Study Groups

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Atropine 0.01%

Group receiving atropine treatment for 18 months

Group Type EXPERIMENTAL

Atropine (0.01%)

Intervention Type DRUG

tropical application

Artifical tear

Group receiving placebo for 18 months

Group Type PLACEBO_COMPARATOR

Artificial tear

Intervention Type DRUG

tropical application

Interventions

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Atropine (0.01%)

tropical application

Intervention Type DRUG

Artificial tear

tropical application

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

7 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The University of Hong Kong

OTHER

Sponsor Role collaborator

The Hong Kong Polytechnic University

OTHER

Sponsor Role lead

Responsible Party

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Henry HL Chan, PhD

Association Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Henry HL CHAN, PhD

Role: PRINCIPAL_INVESTIGATOR

The Hong Kong Polytechnic University

Locations

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School of Optometry, Hong Kong Polytechnic University

Hong Kong, , Hong Kong

Site Status

Countries

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Hong Kong

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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HongKongPU_Optometry1

Identifier Type: -

Identifier Source: org_study_id

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