NCT01695161Unknown不适用
Corneal-Compensated Intraocular Pressure, Corneal Hysteresis and Corneal Resistance Factor Measurements Performed With the Ocular Response Analyzer and Their Correlation to Conventional Goldmann Applanation Tonometry.
Johannes Gutenberg University Mainz1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2012年9月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- agreement between ccIOP and GAT in MPS, Fabry and healthy controls
研究概览
简要总结
The aim of the present study is to compare intraocular pressure (IOP) values assessed with Ocular Response Analyzer to the classical gold standard of IOP measurement, to Goldmann applanation tonometry by mucopolysacchyridosis-, Fabry-patients and healthy controls. We want to investigate biomechanical characteristics of the cornea and their influence on the IOP-measurements.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •MPS I, II, IV, VI patients with at least grade 3 of corneal clouding (Couprie et al.)
- •Fabry patients with cornea verticillata > grade 1
- •Age ≥ 12 years
- •Patient is able to comply with the study procedure
- •Patient has consented to be in the trial
- •Ability to fixate a target
排除标准
- •History of corneal transplantation or refractive surgery
- •Corneal pathologies other than MPS-associated corneal opacity
- •Corneal, conjunctival or intraocular inflammation
结局指标
主要结局
agreement between ccIOP and GAT in MPS, Fabry and healthy controls
时间窗: Sep 2013 (anticipated)
Evaluation of agreement between ccIOP and GAT in MPS, Fabry and healthy controls
次要结局
未报告次要终点
研究者
Susanne Pitz
MD
Johannes Gutenberg University Mainz
研究点 (1)
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