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

Myopia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06282848
• Other study ID #: HongKongPU_Optometry4
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2024
• Est. completion date: December 2026

Study information

• Verified date: March 2024
• Source: The Hong Kong Polytechnic University
• Contact: Henry HL CHAN, PhD
• Phone: 85227667937
• Email: henryhl.chan[@]polyu.edu.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 2026
• Est. primary completion date: December 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 7 Years to 9 Years

Eligibility

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

Related Conditions & MeSH terms

• Myopia

Intervention

Drug:
• Atropine 0.05%
Topical application

Device:
• DIMS lens
Spectacle wear

Locations

Country	Name	City	State
Hong Kong	School of Optometry, Hong Kong Polytechnic University	Hong Kong

Sponsors (2)

Lead Sponsor	Collaborator
The Hong Kong Polytechnic University	The University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Subjective refraction	Refractive error (in Diopter)	up to 24 months
Primary	Axial length	Length of eyeball	up to 24 months
Secondary	mfERG responses	Parameters of mfERG responses	up to 24 months
Secondary	Retinal and choroidal thickness	Thicknesses of retinal layers and choroid	up to 24 months