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临床试验/NCT05559567
NCT05559567Enrolling By Invitation不适用

Axial Length With Adult Onset Myopia

Art Optical Contact Lens, Inc.2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2023年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
100
试验地点
2
主要终点
Axial Length progression

研究概览

简要总结

Purpose: To determine axial length progression and its relationship with myopia onset and progression in adults.

详细描述

Objectives

  1. Determine axial length progression over a two year period of at least 100 subjects/students aged 21 or over (subjects may come from multiple sites). Subjects are to be chosen from optometric education programs beginning in the student's first year.
  2. Determine correlation of axial length changes to refractive changes over the two year period.
  3. Obtain results of orthokeratology and its effect on axial length and refractive changes.

Methods

  1. Measurements of axial length with optical biometry will be taken at yearly intervals for three years and recorded on a spreadsheet (see attached) for future data analysis. Effort will be made to perform measurements at approximately same date each year.
  2. Refractive error will be measured using a consistent method such as an autorefractor at yearly intervals for three years and recorded on same spreadsheet as axial length for future data analysis. Effort will be made to perform measurements at approximately same date each year.
  3. Subjects that are fit into orthokeratology will be fit with the MOONLENS design (provided by Art Optical at no charge) per normal fitting protocol and followed up with normal protocol Axial length will be measured pre-fitting and at least every year for the three year period. Topography will be captured at pre-fitting and post fitting per normal protocol with images taken at least once per year for three year period. Refraction will also be conducted at least once per year. Axial length and refraction data are to be recorded on same spreadsheet as above and topography saved to a separate folder for future analysis.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
21 Years 至 35 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 1st year optometry student
  • Refractive error - spherical Component: +2.00D to -5.00D; astigmatic Component: up to -1.50D; non-presbyopic
  • Not currently using any treatment for myopia control, including Orthokeratology lenses, soft multifocal lenses, MiSight lenses, pharmacological interventions, or spectacles for myopia control
  • No significant anterior or posterior segment disease

排除标准

  • Non-graduate student
  • Refractive error outside of: +2.00D to -5.00D; astigmatic Component: up to -1.50D; presbyopic
  • Any participants using treatment for myopia control, including Orthokeratology lenses, soft multifocal lenses, MiSight lenses, pharmacological interventions, or spectacles for myopia control
  • Significant anterior or posterior segment disease
  • Significant systemic disease that may affect refractive error (i.e. diabetes)

结局指标

主要结局

Axial Length progression

时间窗: Two years

The change in the length of the eye from the anterior cornea to the retina over time

Effect of Orthokeratology on axial length changes

时间窗: Two years

Compare the average axial length changes of subjects wearing orthokeratology lenses to those who do not

次要结局

未报告次要终点

研究者

发起方
Art Optical Contact Lens, Inc.
申办方类型
Industry
责任方
Sponsor

研究点 (2)

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