common.study.topics.clinical

Corneal Sensitivity in Patients with Sleep Apnea Syndrome

common.study.values.description

“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. 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.

common.study.values.location

participant.ui.study.affiliations-map.online-study.header-virtual

participant.ui.study.affiliations-map.online-study.text

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common.study.values.methods

No pharmaceutical medication involved common.study.methods.has-drugs-no
Patients and healthy individuals accepted common.study.methods.is-healthy-no

common.study.methods.no-methods

participant.views.study.view.additional

participant.views.study.view.scientific-title

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

common.study.values.clinical-trial-id

NCT02265133

participant.views.study.view.id

Xe09Ga