SUSPENDED

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

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Conditions

Dry Eye SyndromesCorneal Disease

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Prospective Study to Validate the Imaging Biomarker for Neuropathic Corneal Pain.

Quick Facts

Study Start:2022-12-16
Study Completion:2025-10-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:SUSPENDED

Study ID

NCT05653921

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. 18 years of age or older
  2. 2. Ability to consent
  3. 3. Best corrected visual acuity of 20/40 or better in each eye
  4. 1. Chief complaint is ocular surface discomfort or dry eye disease, but subject reports no ocular pain on OPAS questionnaire
  5. 2. Symptoms lasting at least 3 months
  6. 3. Presence of at least two of the following within the same eye:
  7. 1. Anesthetized Schirmer score =/\< 10mm
  8. 2. Corneal staining of \>3/15 based on NEI scale
  9. 3. Tear break up time \< 10 seconds
  10. 1. Chief complain is ocular surface discomfort or dry eye disease
  11. 2. Symptoms lasting at least 3 months
  12. 3. All of the following in both eyes:
  13. 1. Corneal staining of less than or equal to 3/15 based on NEI scale
  14. 2. Tear break up time =/\> 10 seconds
  15. 4. Must have at least 25% peripheral pain
  16. 5. Subject reported discomfort prior to drop response testing of at least 3 out of 10
  17. 1. No symptoms of ocular surface discomfort or dry eye disease
  18. 2. All of the following in both eyes
  19. 1. Anesthetized Schirmer score \> 10 mm
  20. 2. Corneal staining of less than or equal to 3/15 based on NEI scale
  21. 3. Tear break up time \> 10 seconds
  22. 3. The same sex and within 5 years of age of a patient within the NCP group.
  1. 1. Pregnant or nursing
  2. 2. Irregular corneal disease
  3. 3. Ocular surgery in the past 3 months
  4. 4. Ocular infection in the past 3 months
  5. 5. Active ocular allergies
  6. 6. Participation in a study that could potentially impact the IVCM in the opinion of the investigator
  7. 7. Current use of corneal nerve regeneration therapy that has been on-going for 3 months or more.
  8. 8. For NCP group only, patients for whom their pain and symptoms can be attributed to other causes in the opinion of the investigator

Contacts and Locations

Principal Investigator

Pedram Hamrah, MD
PRINCIPAL_INVESTIGATOR
Tufts Medical Center

Study Locations (Sites)

Tufts Medical Center
Boston, Massachusetts, 02111
United States
Scheie Eye Institute, University of Pennsylvania
Philadelphia, Pennsylvania, 19104
United States

Collaborators and Investigators

Sponsor: Tufts Medical Center

  • Pedram Hamrah, MD, PRINCIPAL_INVESTIGATOR, Tufts Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-12-16
Study Completion Date2025-10-31

Study Record Updates

Study Start Date2022-12-16
Study Completion Date2025-10-31

Terms related to this study

Additional Relevant MeSH Terms

  • Dry Eye Syndromes
  • Corneal Disease