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Ocular GVHD and Corneal Sensation Study

This study is looking at why some people with ocular Graft-versus-Host Disease (GVHD) have persistent eye problems. Researchers believe that damage to the nerves in the clear front part of the eye (cornea) and reduced sensation (hypoesthesia) might be a reason. This study will use a corneal sensation test to measure nerve function in about 30 people with ocular GVHD. The goal is to see how common corneal hypoesthesia is in these patients and if it's connected to other changes on the eye's surface. You may be eligible if you are 18 or older and have chronic GVHD affecting organs other than your eyes, with dry eye symptoms starting after your systemic GVHD developed.

Study design
This is an observational study, meaning researchers will observe and collect information without providing new treatments. It plans to include about 30 participants.
What's involved
You would undergo a thorough eye surface examination, including a corneal sensation test, during a single clinic visit.
Compensation
Not stated in the trial record.
Follow-up
Your corneal hypoesthesia will be measured at a single baseline clinic visit.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04700657

The Prevalence of Hypoesthesia Related Keratitis in Ocular Graft Vs. Host Disease (GVHD) Patients

Recruiting
Not specifiedAges 18+Observational
Indiana University
~30 participants
Updated 2026-08-12 on ClinicalTrials.gov
What's tested:corneal sensation test

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Corneal Hypoesthesia
Measured over Baseline clinic visit

Conditions

Ocular GVHD

Explore related trials

Graft Versus Host Disease

Where it's being run

1 sites across 1 states
Indiana1

Who to contact

Linda Morgan
[email protected]
317-274-2745
Email the study team

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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.

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.

What this trial measures

  • Corneal HypoesthesiaBaseline clinic visit

    Corneal Sensation in GVHD compared to healthy age matched controls as measured with Cochet Bonet esthesiometer.