Pharmacological and Non-pharmacological Treatment Effects on Children With Different Predicted Myopia Progression Rate

Pharmacological (0.05% Atropine) and Non-pharmacological (Defocused Incorporated Multiple Segments Lens) Treatment Effects on the Children With Different Predicted Myopia Progression Rate Measured by Modified Multifocal Electroretinogram

The goal of this clinical trial is to compare pharmacological and non-pharmacological treatment effects on the children with different predicted myopia progression rate measured by modified multifocal electroretinogram. The main questions it aims to answer are:

• the effectiveness of using 0.05% atropine and prescribing DIMS lens for myopia control in children with different myopia progression rates
• the contribution of L/M cones in juvenile myopia progression and changes of retinal activities under atropine and DIMS treatment.

Participants will have baseline and follow-up eye examinations and given either pharmacological treatment with 0.05% atropine or non-pharmacological treatment with DIMS lens for myopia control.

Researchers will compare the changes of refractive errors and axial length after different types of interventions and investigate the relations between the parameters of mfERG responses and the thicknesses of retinal layers and choroid.

Study Overview

• Status: Recruiting
• Conditions: Myopia
• Intervention / Treatment: Drug: Atropine 0.05%; Device: DIMS lens

Detailed Description

This proposed study is a 24-month longitudinal randomized trial that aims to investigate myopia development after either topical application of 0.05% atropine or prescription of DIMS lens in children with various predicted myopia progression rates by their initial retinal responses obtained by multifocal ERG. This will help elucidate the effectiveness of using 0.05% atropine and prescribing DIMS lens for myopia control in children with different myopia progression rates. The retinal electrophysiological investigation will help determine the contribution of L/M cones in juvenile myopia progression and changes of retinal activities under atropine and DIMS treatment.

80 subjects in either gender aged 7 to 9 years will be recruited in this study. They should have spherical equivalent refractive error between -0.5D and -4D in both eyes with best-corrected visual acuity of logMAR 0.00 or better. All should have normal eye health and without systemic diseases or epilepsy. They have not received any myopia control previously. Eligible subjects will have a baseline eye examination and have the first 6-month period monitoring the refractive and ocular changes compared with the baseline control data. After these 6 months, subjects will be classified into either fast or slow myopia progression group in accordance with the results of electrophysiology results and then will further be randomly allocated either intervention group: pharmacological treatment group (daily topical 0.05% atropine) or control group: non-pharmacological treatment group (daily wear of Defocused Incorporated Multiple Segments - DIMS lenses), for 18 months study period with 6-month interval regular follow up.

The primary outcomes are the changes of refractive errors and axial length after different types of interventions and the secondary outcomes are the relations between the parameters of mfERG responses and the thicknesses of retinal layers and choroid.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Henry HL Chan, PhD; Phone Number: 85227667937; Email: henryhl.chan@polyu.edu.hk
• Study Contact Backup: Name: Kaiyip Choi, PhD; Phone Number: 85234002934; Email: kaiyip.choi@polyu.edu.hk

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong, 00000
    • Recruiting
    • School of Optometry, Hong Kong Polytechnic University
    • Contact: Henry HL Chan, PhD; Phone Number: 85227667937; Email: henryhl.chan@polyu.edu.hk
    • Contact: Kaiyip Choi, PhD; Phone Number: 85234002934; Email: kaiyip.choi@polyu.edu.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• be aged between 7 and 9 years
• have no reported eye disorder and no family history of eye disease
• be able to participate in this study for 24 months
• not have any current or history of epilepsy
• not have any current or history of asthma
• have refractive error between 0.50 D and 4.00 D and less than 1.50D of astigmatism with best corrected visual acuity of LogMAR 0.0 or better
• have no detected eye diseases or disorders after eye examination, except myopia

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Atropine 0.05%; Group receiving atropine treatment for 18 months after 6 months of monitoring without intervention	Drug: Atropine 0.05%; Topical application
Experimental: DIMS lens; Group receiving DIMS lens treatment for 18 months after 6 months of monitoring without intervention	Device: DIMS lens; Spectacle wear

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjective refraction	Refractive error (in Diopter)	up to 24 months
Axial length	Length of eyeball	up to 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
mfERG responses	Parameters of mfERG responses	up to 24 months
Retinal and choroidal thickness	Thicknesses of retinal layers and choroid	up to 24 months

Collaborators and Investigators

• Sponsor: The Hong Kong Polytechnic University
• Collaborators: The University of Hong Kong
• Investigators: Principal Investigator: Henry HL CHAN, PhD, The Hong Kong Polytechnic University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: February 21, 2024
• First Submitted That Met QC Criteria: February 21, 2024
• First Posted (Actual): February 28, 2024

Study Record Updates

• Last Update Posted (Estimated): September 17, 2025
• Last Update Submitted That Met QC Criteria: September 11, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Retina; Myopia; Electroretinogram; Atropine; Optical defocus
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Parasympatholytics; Autonomic Agents; Peripheral Nervous System Agents; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Adjuvants, Anesthesia; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Mydriatics; Atropine
• Other Study ID Numbers: HongKongPU_Optometry4

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No