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临床试验/NCT02265133
NCT02265133已完成不适用

Corneal Sensitivity and Nerve Fiber Morphology in Patients With Sleep Apnea Syndrome

University of Texas Southwestern Medical Center2 个研究点 分布在 1 个国家目标入组 130 人开始时间: 2015年7月17日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
130
试验地点
2
主要终点
Corneal Sensitivity

研究概览

简要总结

This study is a prospective, single center clinical trial to assess corneal sensitivity and nerve fiber morphology in patients with sleep apnea compared to normal controls. Healthy volunteers with no history of ocular or uncontrollable systemic disease will be encouraged to participate in the study. After execution and review of the consenting procedures, a detailed history will be taken and a slit lamp examination performed, verifying ocular health. This consists of an examination of both eyes including assessments of ocular lids, lashes, cornea and conjunctival evaluation. Corneal touch thresholds will be tested with a Cochet-Bonnet aesthesiometer, a standard non-invasive measure of corneal sensitivity. Corneal nerves will be imaged using a modified HRT in vivo confocal microscope. The in vivo confocal microscope allows for high resolution imaging of the nerve plexus under the corneal epithelium. This corneal nerve plexus is responsible for corneal sensitively and changes or loss have been established as an early, sensitive indicator of corneal neuropathy. The investigators anticipate that this study will require approximately 30 patients for each group and will last approximately 12 months for recruitment and completion of subject visit phases. There is only one clinical visit designed for this project, unscheduled visits may be scheduled in case of an adverse event.

Patient recruitment will be complete at the one-year time point. At the 14 month time point, all data points will have been collected and assessment of the outcome measure (corneal sensitivity in sleep apnea patients versus control patients) will be complete.

详细描述

Screening Assessment: Following the execution of informed consent, subjects will be carefully screened for ocular signs and symptoms, consistent with the protocol inclusion and exclusion criteria. This includes review of ocular and medical history including use of concomitant & ocular medications and surgeries performed in the past. Researchers will also collect age, ethnicity, demographics, ophthalmic notes and eye exam history. Upon completion of the screening exam, subjects will be deemed eligible based on study criteria the testing procedures will be performed by the investigators.

Testing procedures: The visit will include:

Slit Lamp Microscopy:

An ocular examination of the external (lids, lashes) along with internal (cornea, lens, retina) structures of the eye can be performed with the aid of a slit lamp. This instruments uses lenses and an external light source that can be refracted at different angles and intensities to assess ocular structures for diagnostic purposes.

Corneal sensitivity measurement:

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
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Healthy, non-smoking volunteers.
  • Patients with a diagnosis of sleep apnea.
  • Non-contact lens wearers of any gender and race, ages 18 and up.
  • Minority representation will be proactively encouraged.
  • Patients that are willing to review, understand, and sign the written Informed Consent.
  • Written authorization for use or release of health and research study information.
  • Patients that are willing and able to cooperate with the Investigator and follow all instructions.

排除标准

  • Use of ocular drops including over the counter (OTC) dry eye drops.
  • Previous history of corneal surgery.
  • Previous history of ocular trauma.
  • History of Diabetes Mellitus.
  • Current active or previous history of Herpes virus keratitis.
  • Current or former Contact lens wear.
  • Chronic history of dry eye disease.

结局指标

主要结局

Corneal Sensitivity

时间窗: 1-Day

To investigate whether diminished corneal sensitivity contributes to corneal problems commonly reported in patients with sleep apnea. Specifically, this study will correlate changes in corneal touch thresholds with corneal nerve fiber morphology using in vivo confocal microscopy.

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

Danielle Robertson

Associate Professor of Medicine

University of Texas Southwestern Medical Center

研究点 (2)

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