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Prospective Study to Validate the Imaging Biomarker for NCP (R33)

NCT05653921 · Status: SUSPENDED · Type: OBSERVATIONAL · Enrollment: 438

Last updated 2026-01-07

No results posted yet for this study

Summary

The aim of this study is establish the reliability and clinical utility of microneuromas as identified via in vivo confocal microscopy as the diagnostic biomarker for NCP.

Conditions

  • Dry Eye Syndromes
  • Corneal Disease

Interventions

OTHER

In vivo confocal microscopy (IVCM)

In vivo confocal microscopy (IVCM) allows for visualization of the corneal structures at the cellular level, allowing for assessment of corneal nerves. With a magnification of 800 times, it makes it possible to detect and quantify changes in the epithelial layers and sub-basal nerve plexus.

Sponsors & Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)

    collaborator NIH

  • Tufts Medical Center

    lead OTHER

Principal Investigators

  • Pedram Hamrah, MD · Tufts Medical Center

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-12-16
Primary Completion
2026-07-31
Completion
2026-10-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05653921 on ClinicalTrials.gov