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

• Sponsor: The Hong Kong Polytechnic University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03374306
• Collaborator: The University of Hong Kong (Other)
• Enrollment: 56
• Location: 1
• Arms: 2
• Actual Duration (Months): 32
• Patients Per Site Per Month: 1.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Myopia	Drug: Atropine (0.01%); Drug: Artificial tear	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 56 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Randomized clinical trialRandomized clinical trial
• Masking: Double (Participant, Investigator)
• Masking Description: Double-blinded
• Primary Purpose: Prevention
• 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
• Actual Study Start Date: Jan 1, 2018
• Actual Primary Completion Date: Dec 31, 2019
• Actual Study Completion Date: Aug 31, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Atropine 0.01% Group receiving atropine treatment for 18 months	Drug: Atropine (0.01%); tropical application
Placebo Comparator: Artifical tear Group receiving placebo for 18 months	Drug: Artificial tear; tropical application

Outcome Measures

Primary Outcome Measures

1. Refractive errors [up to 18 months]

   Refractive errors

Secondary Outcome Measures

1. Axial length [up to 18 months]

   Size of the eyeball

Eligibility Criteria

Criteria

• Ages Eligible for Study: 7 Years to 10 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	School of Optometry, Hong Kong Polytechnic University	Hong Kong		Hong Kong	00000

Sponsors and Collaborators

• The Hong Kong Polytechnic University
• The University of Hong Kong

Investigators

• Principal Investigator: Henry HL CHAN, PhD, The Hong Kong Polytechnic University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Henry HL Chan, PhD, Association Professor, The Hong Kong Polytechnic University
• ClinicalTrials.gov Identifier: NCT03374306
• Other Study ID Numbers: HongKongPU_Optometry1
• First Posted: Dec 15, 2017
• Last Update Posted: Aug 26, 2021
• Last Verified: Aug 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Henry HL Chan, PhD, Association Professor, The Hong Kong Polytechnic University: Myopia; Myopia control; Atropine; Electroretinogram; Multifocal Electroretinogram
• Additional relevant MeSH terms: Myopia; Atropine; Lubricant Eye Drops

Study Results

No Results Posted as of Aug 26, 2021