Examining corneal sensation in patients with ocular graft-versus-host disease

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

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
• Enrollment: 30 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Indiana University (Academic / other)
• Locations: 1 site (Indianapolis, Indiana)
• Trial ID: NCT04700657 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older diagnosed with chronic ocular GVHD who exhibit significant dry eye symptoms.

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.

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 performed: 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.

Eligibility 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 this trial is running

Indianapolis, Indiana

• Glick Eye Institute - Indiana University — Indianapolis, Indiana, United States (Recruiting)

Study contacts

• Study coordinator: Linda Morgan

Conditions Ocular GVHD