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临床试验/NCT02117323
NCT02117323已完成不适用

Observational Study on Corneal Opacities in Children

Oregon Health and Science University1 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2011年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
54
试验地点
1
主要终点
Number of suitable subjects

研究概览

简要总结

A prospective observational study on corneal opacities in infants and children (1 month to 18 years old) will be conducted at CHLA. Most of these cases will be due to congenital corneal opacity (e.g. Peter's anomaly, mucopolysacharidoses) or scarring due to infectious keratitis. Sixty (60) subjects will be recruited. The children will be examined under anesthesia with a portable slit-lamp and OCT. An iVue OCT system (Optovue) attached to an operating microscope-style mount at CHLA will be used for the intraoperative scans. Both cross-sectional and 3-D OCT scans will be performed to assess opacity depth, pachymetry map, endothelial defects, and any abnormal adhesion between the cornea, iris and lens. The anterior chamber angle will also be imaged with cross-sectional OCT to assess angle depth, trabecular meshwork, Schwalbe's line, and possible peripheral iridocorneal adhesion or posterior embryotoxon. OCT of the crystalline lens will be obtained to assess the presence of cataract. Slit-lamp photography will be obtained, and gonioscopy will be performed if indicated. Corneal diameter will be measured with a caliper, and intraocular pressure will be measured with a tonopen (Reichert).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
1 Month 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Infants and children (1 month to 18 years of age) with corneal opacity requiring a thorough eye examination.

排除标准

  • Inability to give informed consent.
  • Inability to maintain stable fixation for OCT imaging.
  • Inability to commit to required visits to complete the study.

结局指标

主要结局

Number of suitable subjects

时间窗: 5 years

The primary goal of the study will be to identify subjects suitable for the trial with OCT-guided LALAK. The determination will be based on analysis of clinical history \& OCT corneal images as well as the subjects' willingness to participate in the study.

次要结局

未报告次要终点

研究者

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

David Huang

David Huang, MD, PhD, Weeks Professor of Ophthalmology, Oregon Health and Science University

Oregon Health and Science University

研究点 (1)

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