RECRUITING

OCT Evaluation of Neurotrophic Ulcer Following Treatment With Oxervate

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

Neurotrophic keratitis (NK) is a condition where the cornea, or clear outer covering of the eye, has reduced sensation due to a variety of reasons. In more advanced cases of NK, the cornea can develop an area of thinning called an ulcer. The purpose of this research is to find out if Oxervate (cenegermin-bkbj 0.002%) an FDA-approved treatment for neurotrophic corneal ulcers leads to an increase in thickness of the corneal stroma (middle layer of the cornea) during and after treatment of a neurotrophic ulcer. Corneal thickness will be measured using optical coherence tomography (OCT), a non-contact imaging device used routinely in ophthalmology examinations. Corneal sensation will also be measured during and after treatment with a device called a Cochet-Bonnet esthesiometer to see if the treatment increases corneal sensation.

Official Title

Evaluation of Changes in Corneal Stromal Thickness Using Anterior Segment OCT Following Treatment of Neurotrophic Ulcers With Oxervate

Quick Facts

Study Start:2020-10-01
Study Completion:2024-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04573647

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. * Neurotrophic keratitis with stage 3 neurotrophic ulcer (stromal thinning)
  2. * Decreased corneal sensation relative to fellow eye determined qualitatively using wisp of cotton-tipped applicator to compare sensation in each eye without anesthesia.
  1. * Impending corneal perforation (descemetocele)
  2. * Unable to physically complete diagnostic testing (cannot position head into slit lamp or OCT)
  3. * Unable to commit to 6 month follow up prior to initiating study
  4. * Unable to self-administer study drug following explanation and demonstration by PI and study coordinator
  5. * Active infectious infiltrate clinically worsening by history or clinical appearance
  6. * Pregnancy; patients must agree to use an acceptable form of birth control during study participation.

Contacts and Locations

Study Contact

Brad Kligman, MD
CONTACT
516-627-0033
bkligman@sightmd.com

Principal Investigator

Brad Kligman, MD
PRINCIPAL_INVESTIGATOR
Sight Medical Doctors PLLC

Study Locations (Sites)

SightMD
Manhasset, New York, 11030
United States

Collaborators and Investigators

Sponsor: Sight Medical Doctors PLLC

  • Brad Kligman, MD, PRINCIPAL_INVESTIGATOR, Sight Medical Doctors PLLC

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 Date2020-10-01
Study Completion Date2024-12-31

Study Record Updates

Study Start Date2020-10-01
Study Completion Date2024-12-31

Terms related to this study

Keywords Provided by Researchers

  • Neurotrophic Ulcer
  • Neurotrophic Keratoconjunctivitis
  • Optical Coherence Tomography
  • OCT

Additional Relevant MeSH Terms

  • Neurotrophic Ulcer
  • Neurotrophic Keratitis
  • Neurotrophic Corneal Ulcer
  • Neurotrophic Keratoconjunctivitis