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临床试验/NCT06282848
NCT06282848招募中不适用

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 Hong Kong Polytechnic University1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2024年1月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
招募中
入组人数
80
试验地点
1
主要终点
Axial length

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Investigator)

盲法说明

Double-blinded

入排标准

年龄范围
7 Years 至 9 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 未提供

研究组 & 干预措施

Atropine 0.05%

Active Comparator

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

干预措施: Atropine 0.05% (Drug)

DIMS lens

Experimental

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

干预措施: DIMS lens (Device)

结局指标

主要结局

Axial length

时间窗: up to 24 months

Length of eyeball

Subjective refraction

时间窗: up to 24 months

Refractive error (in Diopter)

次要结局

  • mfERG responses(up to 24 months)
  • Retinal and choroidal thickness(up to 24 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Henry HL Chan, PhD

Professor

The Hong Kong Polytechnic University

研究点 (1)

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