Investigation of the Prevalence of Hypoesthesia Related Neurotrophic Keratitis in Patients with Ocular Graft Versus Host Disease

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
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• 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.

Locations
United States
Indiana
Glick Eye Institute - Indiana University
RECRUITING
Indianapolis
Contact Information
Primary
Linda Morgan
lismorga@iupui.edu
317-274-2745
Backup
Michele Spriggs
mmmcpher@iupui.edu
317-274-2745
Time Frame
Start Date: 2020-12-17
Estimated Completion Date: 2026-12
Participants
Target number of participants: 30
Treatments
15 patients affected by ocular GVHD
15 age-matched normal volunteers.
Sponsors
Leads: Indiana University

This content was sourced from clinicaltrials.gov