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

NCT06282848 | Recruiting

• 1 other identifier: HongKongPU_Optometry4
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Myopia

Keywords

Myopia; Atropine; Optical defocus; Electroretinogram; Retina

Outcome Measures

Primary Outcomes (2)

• Subjective refraction

  Refractive error (in Diopter)

  up to 24 months

• Axial length

  Length of eyeball

  up to 24 months

Secondary Outcomes (2)

• mfERG responses

  up to 24 months

• Retinal and choroidal thickness

  up to 24 months

Study Arms (2)

Atropine 0.05%

ACTIVE COMPARATOR

Group receiving atropine treatment for 18 months after 6 months of monitoring without intervention

Drug: Atropine 0.05%

DIMS lens

EXPERIMENTAL

Group receiving DIMS lens treatment for 18 months after 6 months of monitoring without intervention

Device: DIMS lens

Interventions

Atropine 0.05% DRUG

Topical application

Atropine 0.05%

DIMS lens DEVICE

Spectacle wear

DIMS lens

Eligibility Criteria

• Age: 7 Years - 9 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

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

RECRUITING

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Officials

• Henry HL CHAN, PhD

  The Hong Kong Polytechnic University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Henry HL CHAN, PhD

CONTACT

85227667937; henryhl.chan@polyu.edu.hk

Kaiyip CHOI, PhD

CONTACT

85234002934; kaiyip.choi@polyu.edu.hk

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: Professor

Model Details: Randomized clinical trial

Study Record Dates

• First Submitted: February 21, 2024
• First Posted: February 28, 2024
• Study Start: January 1, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: September 17, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)