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R33

Prospective study to validate the imaging biomarker for neuropathic corneal pain

medical-cross
Dry eyes
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All genders
person-wave 18+
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Overview

Principal Investigator: Pedram Hamrah, MD

This study is designed to test a potential biomarker to identify NCP patients. A biomarker is a characteristic that is unique to NCP patients and will help to identify them from DED patients so that correct treatment can be provided to them.

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Study details

Inclusion Criteria
  • Dry Eye Disease (DED) Group: complaint of ocular surface discomfort or dry eye disease; symptoms lasting at least 3 months; presence of 2 markers (Anesthetized Schirmer's score <10mm; corneal staining of >3/15; or Tear breakup time <10 seconds)
  • Neuropathic Corneal Pain (NCP) Group: complaint of ocular surface discomfort or dry eye disease; symptoms lasting at least 3 months; presence of 2 markers (Anesthetized Schirmer's score >10mm; corneal staining of 10 seconds)
  • Control Group: No symptoms of ocular surface discomfort or dry eye disease; All in the following of both eyes:Anesthetized Schirmer's score >10mm; corneal staining of 10 seconds); the same sex and within 5 years of age of a patient in the NCP group
Exclusion Criteria
  • Pregnant or nursing
  • Irregular corneal disease
  • Ocular surgery or infection in the past 3 months
Study Requirements

DED, NCP, and control group participants will have a standard of care visit and the In-vivo confocal microscopy (IVCM). A set number of participants will also be asked to complete a follow-up IVCM at a separate, research-only, visit. 

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