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NCT02265133 · ClinicalTrials.gov registry record
Corneal Sensitivity in Patients With Sleep Apnea Syndrome
A clinical trial, sponsored by University of Texas Southwestern Medical Center.
- Completed
- Registry status
- 130
- Enrollment target
NCT02265133: Completed study, sponsored by University of Texas Southwestern Medical Center.
NCT02265133 is a clinical trial that has completed, run by University of Texas Southwestern Medical Center. The registered enrollment target is 130 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02265133 has completed, sponsored by University of Texas Southwestern Medical Center.
- COMPLETED
- Registry status
- 130 participants
- Enrollment target
Study Summary
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.
Primary Outcome
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.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 130 participants |
| Start Date | 2015-07-17 |
| Est. Completion | 2024-08-20 |
What the finished NCT02265133 record still lists
NCT02265133 is an observational study that tracks outcomes without assigning an intervention. The registered 130 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT02265133 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02265133 about?
NCT02265133 is a clinical study titled "Corneal Sensitivity in Patients With Sleep Apnea Syndrome". 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....
What is the current status of trial NCT02265133?
This trial is currently completed. The enrollment target is 130 participants. The study started on 2015-07-17. Estimated completion is 2024-08-20.
Who is sponsoring clinical trial NCT02265133?
This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.
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