Examining corneal sensation in patients with ocular graft-versus-host disease
Official title: Investigation of the Prevalence of Hypoesthesia Related Neurotrophic Keratitis in Patients With Ocular Graft Versus Host Disease
Run by Indiana University · NCT04700657 · Data updated 2026-11-12
This study is trying to see if patients with ocular graft-versus-host disease have reduced corneal sensation and how it relates to their dry eye symptoms and eye surface health.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | Indiana University Academic / other |
| Locations | 1 site (Indianapolis, Indiana) |
| Status | Recruiting |
| Started | December 17, 2020 |
| Main results expected | June 2028 |
| Study ends | June 2028 |
| Registry record updated | August 12, 2026 |
| Trial ID | NCT04700657 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults aged 18 and older diagnosed with chronic ocular GVHD who exhibit significant dry eye symptoms.
✕Probably not a fit
Patients whose dry eye symptoms preceded the development of systemic GVHD or those without ocular GVHD may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to investigate the prevalence of corneal hypoesthesia in patients suffering from ocular graft-versus-host disease (GVHD) and its relationship with ocular surface changes. The researchers will assess corneal sensation through specific tests and correlate these findings with ocular surface staining, tear film stability, and meibomian gland function. The study focuses on patients diagnosed with chronic GVHD who exhibit dry eye symptoms following their systemic GVHD diagnosis. By understanding the connection between corneal nerve damage and ocular symptoms, the study seeks to provide insights into the management of ocular complications in GVHD patients.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and management of ocular complications in GVHD patients, enhancing their quality of life.
How similar studies have gone: While there have been some confocal microscopy studies on corneal nerve changes in GVHD, this study's approach to correlating corneal sensation with ocular surface health is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
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Glick Eye Institute - Indiana University
Indianapolis, Indiana, United States Recruiting
Study contacts
- Study coordinator: Linda Morgan
- Email: lismorga@iupui.edu
- Phone: 317-274-2745
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.