QST for Corneal Nerve Function (NCT05758753) | Clinical Trial Compass
SuspendedNot Applicable
QST for Corneal Nerve Function
Stopped: PI is leaving institution. USF will likely resume study activity but TMC is no longer conitinuing study activity.
United States108 participantsStarted 2023-05-16
Plain-language summary
This study is designed to learn more about the impact different types of stimuli, such as heat, cold and vibration, can have on ocular pain response. This is called quantitative sensory testing (QST). Most procedures being performed in this study, except the QST, are standard of care which means they are performed during the participant's routine eye examination.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Clinical findings of Stage I NK
✓. Decreased nerve density by IVCM
✓. Decreased corneal sensation
✓. Clinical findings of Stage II NK
✓. Decreased nerve density by IVCM
✓. Decreased corneal sensation
✓. Symptoms of DED at least 3 months
✓. Presence of at least one of the following DED signs; tear film break-up time lower than 7, ocular surface staining more than +1 based on NIH scale
Exclusion criteria
✕. History of diabetes
✕. History of ocular surgery, corneal infection, or corneal injury within the last 3 months
✕. Systemic regular anti-inflammatory and/or steroid and/or immune-modulatory therapy in the last 3 months
What they're measuring
1
Thermal stimulus response to QST on site of trigeminal nerve first branch, as assessed by cold detection threshold (CDT) and hot detection threshold (HDT)
Timeframe: From visit 1 up to 4 weeks
2
Mechanical stimulus response to QST on site of trigeminal nerve first branch, as assessed by vibration detection threshold (VDT)
Timeframe: From visit 1 up to 4 weeks
3
Differences in thermal stimulus pain threshold across the 4 study arms
Timeframe: From visit 1 up to 4 weeks
4
Differences in mechanical stimulus pain threshold across the 4 study arms