Clinical trial NCT06282848: Pharmacological and Non-pharmacological Treatment Effects on Children With Different Predicted Myopia Progression Rate
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Myopia
Keywords: Myopia
Atropine
Optical defocus
Electroretinogram
Retina
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
Collaborators: name: The University of Hong Kong
First posted: 2024-02-28
Enrollment: 80
Sex: ALL
Minimum age (years): 7
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized clinical trial
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Subjective refraction
timeFrame: up to 24 months
measure: Axial length
timeFrame: up to 24 months
Secondary outcomes:
measure: mfERG responses
timeFrame: up to 24 months
measure: Retinal and choroidal thickness
timeFrame: up to 24 months
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: School of Optometry, Hong Kong Polytechnic University
Study officials:
affiliation: The Hong Kong Polytechnic University
name: Henry HL CHAN, PhD
role: PRINCIPAL_INVESTIGATOR
References: