QST for Corneal Nerve Function

Last updated: January 6, 2026
Sponsor: Tufts Medical Center
Overall Status: Suspended

Phase

N/A

Condition

Eye Disorders/infections

Dry Eyes

Sjogren's Syndrome

Treatment

Quantitative Sensory Test

Clinical Study ID

NCT05758753
STUDY00002510
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Group 1: Stage I Neurotrophic Keratopathy (NK)

  1. Clinical findings of Stage I NK

  2. Decreased nerve density by IVCM

  3. Decreased corneal sensation

Group 2: Stage II NK

  1. Clinical findings of Stage II NK

  2. Decreased nerve density by IVCM

  3. Decreased corneal sensation

Group 3: Dry Eye Disease (DED)

  1. Symptoms of DED at least 3 months

  2. Presence of at least one of the following DED signs; tear film break-up time lowerthan 7, ocular surface staining more than +1 based on NIH scale

  3. Normal or mildly effected corneal sensation

Group 4: Healthy Individuals

  1. Absence of any ocular surface symptoms

  2. Absence of ocular surface findings

  3. Transparent and clear cornea

  4. Normal corneal sensation

Group 5: NCP

  1. Presence of neuropathic symptoms AND

  2. Symptoms out of proportion to clinical findings AND

  3. Nerve abnormalities detected by in vivo confocal microscopy

Exclusion

Exclusion Criteria:

  1. History of diabetes

  2. History of ocular surgery, corneal infection, or corneal injury within the last 3months

  3. Systemic regular anti-inflammatory and/or steroid and/or immune-modulatory therapyin the last 3 months

  4. Active ocular allergies

  5. Any major psychiatric illness including bipolar, psychosis, obsessive-compulsivedisorder and major depression

  6. Pregnancy

  7. History of surgery within the last 3 months

  8. History of , sarcoidosis, GVHD or collagen vascular disease

  9. Allergic to benzalkonium chloride "BAK" (an eye-drop preservative)

  10. Concurrent enrollment in other studies that in the opinion of the investigator willinterfere with the results of this study

  11. Non-English speakers

Study Design

Total Participants: 108
Treatment Group(s): 1
Primary Treatment: Quantitative Sensory Test
Phase:
Study Start date:
May 16, 2023
Estimated Completion Date:
June 30, 2027

Study 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.

Connect with a study center

  • Tufts Medical Center

    Boston 4930956, Massachusetts 6254926 02111
    United States

    Site Not Available

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