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R33

Title Prospective study to validate the imaging biomarker for neuropathic corneal pain
Therapeutic Area Dry Eye
Principal Investigator Pedram Hamrah, MD
Min Age 18 Years
Gender Any
Contact Ophthalmology Coordinator
617-636-5489
neecresearch@tuftsmedicalcenter.org
More Information https://clinicaltrials.gov/ct2/show/NCT05653921

Overview

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.

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.