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Search / Trial NCT05758753

QST for Corneal Nerve Function

Launched by TUFTS MEDICAL CENTER · Feb 24, 2023

Trial Information

Current as of June 26, 2025

Enrolling by invitation

Keywords

Quantitative Sensory Test

ClinConnect Summary

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 oth...

Gender

ALL

Eligibility criteria

  • 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 lower than 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 Criteria:
  • 1. History of diabetes
  • 2. History of ocular surgery, corneal infection, or corneal injury within the last 3 months
  • 3. Systemic regular anti-inflammatory and/or steroid and/or immune-modulatory therapy in the last 3 months
  • 4. Active ocular allergies
  • 5. Any major psychiatric illness including bipolar, psychosis, obsessive-compulsive disorder 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 will interfere with the results of this study
  • 11. Non-English speakers

About Tufts Medical Center

Tufts Medical Center is a leading academic medical institution located in Boston, Massachusetts, renowned for its commitment to advancing healthcare through innovative research and clinical trials. As a sponsor of clinical trials, Tufts Medical Center leverages its expertise in diverse medical disciplines to develop and test new therapies, enhance patient care, and contribute to the scientific community. With a focus on collaboration and rigorous methodologies, the center aims to translate research findings into practical applications that improve health outcomes for patients locally and globally. Its dedication to excellence is reflected in its partnerships with academic institutions, industry leaders, and healthcare organizations.

Locations

Boston, Massachusetts, United States

Patients applied

0 patients applied

Trial Officials

Pedram Hamrah, MD

Principal Investigator

Tufts Medical Center

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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