Status:
RECRUITING
The Prevalence of Hypoesthesia Related Keratitis in Ocular Graft Vs. Host Disease (GVHD) Patients
Lead Sponsor:
Indiana University
Conditions:
Ocular GVHD
Eligibility:
All Genders
18+ years
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 hypo...
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, gastrointe...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 17 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04700657
Start Date
December 17 2020
End Date
December 1 2027
Last Update
October 23 2025
Active Locations (1)
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1
Glick Eye Institute - Indiana University
Indianapolis, Indiana, United States, 46202