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

NCT03374306 | Completed Results

• 1 other identifier: HongKongPU_Optometry1
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

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.

Conditions

Myopia

Keywords

Myopia; Myopia control; Atropine; Electroretinogram; Multifocal Electroretinogram

Outcome Measures

Primary Outcomes (1)

• Annualized Changes in Refractive Error (SER)

  Annualized changes in refractive error (SER) after receiving the 0.01 atropine or artificial tears up to 18 months

  18 months

Secondary Outcomes (1)

• Annualized Change in Axial Length

  18 months

Study Arms (2)

Atropine 0.01%

EXPERIMENTAL

Group receiving atropine treatment for 18 months

Drug: Atropine (0.01%)

Artifical tear

PLACEBO COMPARATOR

Group receiving placebo for 18 months

Drug: Artificial tear

Interventions

Atropine (0.01%) DRUG

tropical application

Atropine 0.01%

Artificial tear DRUG

tropical application

Artifical tear

Eligibility Criteria

• Age: 7 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead
• The University of Hong Kong: collaborator

Study Sites (1)

School of Optometry, Hong Kong Polytechnic University

Hong Kong, 00000, Hong Kong

Location

MeSH Terms

Conditions

Myopia

Interventions

Atropine; Lubricant Eye Drops

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Intervention Hierarchy (Ancestors)

Atropine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Belladonna Alkaloids; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring; Ophthalmic Solutions; Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Lubricants; Specialty Uses of Chemicals

Results Point of Contact

• Title: Prof. Henry Chan
• Organization: HK Polytechnic University

henryhl.chan@polyu.edu.hk

+85227667937

Study Officials

• Henry HL CHAN, PhD

  The Hong Kong Polytechnic University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double-blinded
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Association Professor

Model Details: Randomized clinical trial

Study Record Dates

• First Submitted: December 11, 2017
• First Posted: December 15, 2017
• Study Start: February 1, 2018
• Primary Completion: December 31, 2019
• Study Completion: August 31, 2020
• Last Updated: October 16, 2024
• Results First Posted: October 16, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)