Corneal Sensitivity in Patients With Sleep Apnea Syndrome
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Sleep Apnea
- Type
- Observational
- Design
- Observational Model: Case-ControlTime Perspective: Prospective
Participation Requirements
- Age
- Between 18 years and 90 years
- Gender
- Both males and females
Description
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 an...
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: Corneal touch sensitivity will be determined using a Cochet-Bonnet aesthesiometer mounted on a standard slit lamp biomicroscope. The Cochet-Bonnet aesthesiometer is routinely used for clinical research purposes to investigate corneal touch thresholds. For sensitivity measurements, a 0.12 mm diameter nylon thread will be slowly brought forward to briefly touch the cornea perpendicularly and then quickly withdrawn. On each occasion, the patient will be asked to respond whenever a stimulus is felt. Thread length is used to quantitatively assess sensitivity. The longest thread length is used first (6 cm), as this provides the lowest stimulus intensity. If the subject is unable to detect the touch stimulus, the thread will be systematically shortened in length by 0.5 cm steps until the stimulus is felt. The criterion for the sensitivity threshold will be the filament length which gives a 50% positive response from four stimulus applications. In Vivo Confocal Microscope Corneal nerves will be imaged using a modified in vivo confocal microscope which is routinely used in our clinics (HRT Rostock corneal module, Heidelberg Engineering). The HRT In Vivo Confocal microscope was modified by adding a motor to automate the focus. This does not alter the integrity, the application, the intent or the light source of the instrument. Corneas will be anesthetized with a topical anesthetic, proparacaine, prior to scanning. The confocal microscope will briefly touch the patient's eye and the images saved for further analysis.
Tracking Information
- NCT #
- NCT02265133
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Danielle Robertson, O.D, PhD UTSW Medical Center at Dallas