NCT05758753

QST for Corneal Nerve Function

The Efficacy of Quantitative Sensory Test (QST) in Assessing Corneal Nerve Functions in Patients With Ocular Surface Diseases

• Status: Suspended
• Phase: N/A
• Study type: Interventional
• Enrollment: 108 (estimated)
• Sponsor: Tufts Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed description

Quantitative Sensory Test (QST) is a non-invasive neurophysiological method that refers to a group of procedures that assess the perceptual responses to systematically applied and quantifiable sensory stimuli for the purpose of characterizing somatosensory function or dysfunction. In this study, we propose to evaluate corneal nerve functions in patients with corneal nerve abnormalities by QST and correlate the nerve functions with symptoms, clinical signs and nerve morphology detected by In-Vivo Confocal Microscopy (IVCM). Identification of corneal nerve functions and correlations with other findings may help us to understand underlying pathological mechanisms of the disease and may guide us toward new treatment targets. We hypothesize that, QST may provide us detailed information about corneal nerve function alterations and may correlate with morphological nerve changes detected by IVCM.

Conditions

• Corneal Disease
• Neuropathy
• Dry Eye Disease
• Neurotrophic Keratitis

Interventions

Type	Name	Description
DEVICE	Quantitative Sensory Test	Quantitative Sensory Test (Medoc Ltd, Israel), QST is a non-invasive neurophysiological method that refers to a group of procedures that assess the perceptual responses to systematically applied and quantifiable sensory stimuli (modalities including heat, cold and vibration) for the purpose of characterizing somatosensory function or dysfunction. For this test, subjects will be seated comfortably on a chair in a quiet room, or laying supine in a horizontal examination chair, with ambient temperature of 24-25◦ C. Medial upper eyelid; just below the supraorbital notch, nasolacrimal sac area; 4-5 mm medial to nasal cantus, and non-dominant forearm will be used as test sites. Patients will be instructed in detail of the nature of the test and the need to react attentively and promptly to change in temperatures.

Timeline

• Start date: 2023-05-16
• Primary completion: 2026-10-31
• Completion: 2027-06-30
• First posted: 2023-03-07
• Last updated: 2026-01-08

Locations

1 site across 1 country: United States