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

Last updated: April 18, 2025
Sponsor: Tufts Medical Center
Overall Status: Active - Recruiting

Phase

N/A

Condition

Eye Disease

Treatment

In vivo confocal microscopy (IVCM)

Clinical Study ID

NCT05653921
STUDY00003018
4R33NS113341-02
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

All Subjects:

  1. 18 years of age or older

  2. Ability to consent

  3. Best corrected visual acuity of 20/40 or better in each eye

Dry Eye Disease Group:

  1. Chief complaint is ocular surface discomfort or dry eye disease, but subject reportsno ocular pain on OPAS questionnaire

  2. Symptoms lasting at least 3 months

  3. Presence of at least two of the following within the same eye:

  4. Anesthetized Schirmer score =/< 10mm

  5. Corneal staining of >3/15 based on NEI scale

  6. Tear break up time < 10 seconds

Neuropathic Corneal Pain Group:

  1. Chief complain is ocular surface discomfort or dry eye disease

  2. Symptoms lasting at least 3 months

  3. All of the following in both eyes:

  4. Corneal staining of less than or equal to 3/15 based on NEI scale

  5. Tear break up time =/> 10 seconds

  6. Must have at least 25% peripheral pain

  7. Subject reported discomfort prior to drop response testing of at least 3 out of 10

Control Group:

  1. No symptoms of ocular surface discomfort or dry eye disease

  2. All of the following in both eyes

  3. Anesthetized Schirmer score > 10 mm

  4. Corneal staining of less than or equal to 3/15 based on NEI scale

  5. Tear break up time > 10 seconds

  6. The same sex and within 5 years of age of a patient within the NCP group.

Exclusion

Exclusion Criteria:

  1. Pregnant or nursing

  2. Irregular corneal disease

  3. Ocular surgery in the past 3 months

  4. Ocular infection in the past 3 months

  5. Active ocular allergies

  6. Participation in a study that could potentially impact the IVCM in the opinion ofthe investigator

  7. Current use of corneal nerve regeneration therapy that has been on-going for 3months or more.

  8. For NCP group only, patients for whom their pain and symptoms can be attributed toother causes in the opinion of the investigator

Study Design

Total Participants: 438
Treatment Group(s): 1
Primary Treatment: In vivo confocal microscopy (IVCM)
Phase:
Study Start date:
December 16, 2022
Estimated Completion Date:
July 14, 2025

Study Description

Dry Eye Disease (DED) is a multifactorial disease of the ocular surface characterized by a loss of homeostasis of the tear film, and accompanied by ocular symptoms, in which tear film instability and hyperosmolarity, ocular surface inflammation and damage, and neurosensory abnormalities.

Neuropathic corneal pain (NCP), an ocular and severe type of neuropathic pain describes patients with symptoms of ocular discomfort out of proportion with clinical signs. The lack of clinical signs observed by standard ophthalmic examination has resulted in underdiagnosis of NCP or misdiagnosis as dry eye disease. Thus, having a biomarker for NCP is critical to identify and treat these patients. No biomarker or clinical signs exists to identify NCP patients.

Investigating corneal neurosensory abnormalities could help to diagnose NCP and potentially differentiate these patients from those with DED. In vivo confocal microscopy (IVCM) allows for real-time optical biopsies at a quasi-histological level, allowing for assessment of corneal nerves. IVCM non-invasive diagnostic imaging across NCP, DED, and healthy individuals will be analyzed to validate corneal microneuromas as a biomarker for NCP.

Connect with a study center

  • Tufts Medical Center

    Boston, Massachusetts 02111
    United States

    Active - Recruiting

  • Scheie Eye Institute, University of Pennsylvania

    Philadelphia, Pennsylvania 19104
    United States

    Active - Recruiting

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