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The Prevalence of Hypoesthesia Related Keratitis in Ocular Graft Vs. Host Disease (GVHD) Patients

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ClinicalTrials.gov Identifier: NCT04700657
Recruitment Status : Recruiting
First Posted : January 8, 2021
Last Update Posted : September 5, 2021
Sponsor:
Information provided by (Responsible Party):
Shaohui Liu, Indiana University

Study Description
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Brief Summary:
The Investigators hypothesize that the recalcitrant nature of ocular GVHD may be related to corneal nerve damage and corneal hypoesthesia. The investigators aim to study the prevalence of corneal hypoesthesia in GVHD patients and its correlation with ocular surface changes.

Condition or disease
Ocular GVHD

Detailed Description:

Rationale: Graft-versus-host disease(GVHD) is a common complication of allogeneic bone marrow or hematopoietic stem cell transplantation (HSCT). It affects multiple systems, including skin, gastrointestinal system, liver, lung, and oral cavity, as well as eyes, which contributes to decreased quality of life and increased mortality. About 10% of patients with acute GVHD and 60-90% of those with chronic GVHD develop ocular complications. Dry eye is the most common manifestation of ocular GVHD. The pathogenesis remains unclear. The conjunctival tissue and cornea are the main immunological targets in GVHD. Patients often have punctate hypothesize that the recalcitrant nature of ocular GVHD may be related to corneal nerve damage and sensation changes.

There are a few confocal microscopy studies on corneal nerve changes in GVHD, including increased tortuosity and reduced reflectivity of sub-basal nerves. However, there were very few studies on clinical correlations of those microscopic changes with corneal sensation and ocular surface health. In addition, confocal microscopes are not widely available in clinical practice. It also requires the special expertise of technicians and physicians to obtain and explain the images. It is therefore not feasible to routinely perform confocal microscopy for corneal innervation study.

The investigators plan to study the corneal sensation changes and their correlation with ocular surface staining, tear film breakdown and meibomian gland dysfunction in GVHD patients. The study will shed light on an important aspect of corneal innervation damage in GVHD and may lead to new treatment modalities for those patients, noting that topical recombinant human nerve growth factor cenegermin was recently FDA approved for neurotrophic keratopathy. The investigators intend to identify the ocular characteristics of GVHD patients that may potentially benefit from cenegermin treatment.

Study Design
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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Investigation of the Prevalence of Hypoesthesia Related Neurotrophic Keratitis in Patients With Ocular Graft Versus Host Disease
Actual Study Start Date : December 17, 2020
Estimated Primary Completion Date : May 2023
Estimated Study Completion Date : August 2023

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
15 patients affected by ocular GVHD
15 age-matched normal volunteers.


Outcome Measures
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Primary Outcome Measures :
  1. Corneal Hypoesthesia [ Time Frame: Baseline clinic visit ]
    Corneal Sensation in GVHD compared to healthy age matched controls as measured with Cochet Bonet esthesiometer.


Secondary Outcome Measures :
  1. dry eye questionnaire, dry eye signs, meibomian gland dysfunction [ Time Frame: Baseline clinic visit ]
    1. correlation between corneal hypoesthesia and OSDI questionaire (scale 0-100 points, where higher is worse symptoms)
    2. correlation between corneal hypoesthesia and measure of tear break up time (seconds, where less is worse)
    3. correlation between corneal hypoesthesia and bulbar redness (scale 0-4 where higher is worse)
    4. correlation between corneal hypoesthesia and tear meniscus height (measured in mm where less than 0.2mm is worse)
    5. correlation between corneal hypoesthesia and meibomiography using oculus keratograph ( lower is better)
    6. correlation between corneal hypoesthesia and fluorescein staining at slit lamp (NEI scale 0-15 where higher is worse)
    7. correlation between corneal hypoesthesia and lissamine green staining (NEI scale 0-8 where higher is worse)
    8. correlation between corneal hypoesthesia and schirmer test without anesthesia (measured in mm at 5 minutes where fewer mm of wetting is worse)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
30 eyes from 15 patients affected by ocular GVHD, and 30 healthy control eyes from 15 age-matched normal volunteers.
Criteria

Inclusion Criteria:

  • Chronic GVHD is diagnosed based on the history of allogeneic HSCT (Hematopoietic stem cell transplant) and the presence of systemic GVHD in organs other than the eye. In the ocular GVHD group, dry eye symptoms start after the development of systemic GVHD. If post-HSCT dry eye precedes GVHD clinical signs in other organs, the investigators will use the 2013 diagnostic criteria by International chronic ocular GVHD consensus group.
  • The investigators will recruit patients for the study. The investigators plan to include ocular GVHD patients that are of age 18 years or older who have typical symptoms of dry eye with an Ocular Surface Disease Index (OSDI) score greater than 13 and corneal fluorescein staining (CFS) score of 3 or more (National Eye Institute [NEI] grading scale, 0-15). Normal age-matched volunteer group will include people whose OSDI less or equal to 13 and CFS score less than 3.

The patients will continue their current systemic and ocular medications, which may include one or combination of preservative free artificial tears, restasis or xiidra, serum tears, ointment, or scleral contact lens.

Exclusion Criteria:

  • patients with a history of herpetic simplex or zoster keratitis, ocular or neurologic surgery (including laser or refractive surgical procedure) within 3 months before enrollment, trauma, diabetes with signs of peripheral neuropathy.
  • patients with active corneal thinning or infection.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04700657


Contacts
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Contact: Linda Morgan 317-274-2745 lismorga@iupui.edu
Contact: Michele Spriggs 317-274-2745 mmmcpher@iupui.edu

Locations
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United States, Indiana
Glick Eye Institute - Indiana University Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Linda Morgan    317-274-2745    lismorga@iupui.edu   
Contact: Michele Spriggs    317-274-2745    mmmcpher@iupui.edu   
Sponsors and Collaborators
Indiana University
More Information
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Responsible Party: Shaohui Liu, Principal Investigator, Indiana University
ClinicalTrials.gov Identifier: NCT04700657    
Other Study ID Numbers: 2004207079
First Posted: January 8, 2021    Key Record Dates
Last Update Posted: September 5, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hypesthesia
Keratitis
Corneal Diseases
Eye Diseases
 Somatosensory Disorders
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases