Corneal Sensitivity in Patients With Sleep Apnea Syndrome
Completed
Conditions studied: Sleep Apnea
In brief
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.
Key facts
- Study ID
- NCT02265133
- Run by
- University of Texas Southwestern Medical Center
- People needed
- 130
- Starts
- 2015-07-17
- Expected to finish
- 2024-08-20
- Last updated by the study team
- 2024-08-21
Who can join
Age: 18 and older, up to 90. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Parkland Hospital — Dallas, Texas, United States
- Aston Ambulatory Care Center — Dallas, Texas, United States
Full record on ClinicalTrials.gov
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