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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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06282848
Enrollment
80
Registered
2024-02-28
Start date
2024-01-01
Completion date
2026-12-31
Last updated
2025-09-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myopia

Keywords

Myopia, Atropine, Optical defocus, Electroretinogram, Retina

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.

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.

Interventions

DRUGAtropine 0.05%

Topical application

DEVICEDIMS lens

Spectacle wear

Sponsors

The University of Hong Kong
CollaboratorOTHER
The Hong Kong Polytechnic University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)

Masking description

Double-blinded

Intervention model description

Randomized clinical trial

Eligibility

Sex/Gender
ALL
Age
7 Years to 9 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Subjective refractionup to 24 monthsRefractive error (in Diopter)
Axial lengthup to 24 monthsLength of eyeball

Secondary

MeasureTime frameDescription
mfERG responsesup to 24 monthsParameters of mfERG responses
Retinal and choroidal thicknessup to 24 monthsThicknesses of retinal layers and choroid

Countries

Hong Kong

Contacts

Primary ContactHenry HL CHAN, PhD
henryhl.chan@polyu.edu.hk85227667937
Backup ContactKaiyip CHOI, PhD
kaiyip.choi@polyu.edu.hk85234002934

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026