Ocular GVHDDiagnostics and screeningHealthy volunteersDiagnostic test
What this study is
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.
What's being tested
- corneal sensation test
Intervention · DIAGNOSTIC TEST
Thorough ocular surface study including corneal sensation test in the GVHD group, comparing to the normal control group
Study details
- Official title
- Investigation of the Prevalence of Hypoesthesia Related Neurotrophic Keratitis in Patients With Ocular Graft Versus Host Disease
- Sponsor
- Indiana University
- Conditions
- Ocular GVHD
- Enrolling
- 30 people
- Starts
- 2020-12-17
- Est. completion
- 2028-06
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers AcceptedYou may qualify if
- 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.
You can't join if
- 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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1
Study locations (1)
1 openGlick Eye Institute - Indiana University
Indianapolis, Indiana, United States
- Linda Morgan · Contact317-274-2745lismorga@iupui.edu
- Michele Spriggs · Contact317-274-2745mmmcpher@iupui.edu
Recruiting
Study team
Sponsor
Indiana University
Study ID 2004207079
Have questions? The contacts above can answer them before you apply.
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.