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
- 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.
- Determine correlation of axial length changes to refractive changes over the two year period.
- Obtain results of orthokeratology and its effect on axial length and refractive changes.
Methods
- 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.
- 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.
- 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
- 是
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
研究点 (2)
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