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

NCT04700657 | Recruiting

• 1 other identifier: 2004207079
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ocular GVHD

Outcome Measures

Primary Outcomes (1)

• Corneal Hypoesthesia

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

  Baseline clinic visit

Secondary Outcomes (1)

• dry eye questionnaire, dry eye signs, meibomian gland dysfunction

  Baseline clinic visit

Study Arms (2)

15 patients affected by ocular GVHD

Diagnostic Test: corneal sensation test

15 age-matched normal volunteers.

Diagnostic Test: corneal sensation test

Interventions

corneal sensation test DIAGNOSTIC_TEST

Thorough ocular surface study including corneal sensation test in the GVHD group, comparing to the normal control group

15 age-matched normal volunteers.; 15 patients affected by ocular GVHD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

30 eyes from 15 patients affected by ocular GVHD, and 30 healthy control eyes from 15 age-matched normal volunteers.

You 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 may not qualify 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.

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

Glick Eye Institute - Indiana University

Indianapolis, Indiana, 46202, United States

RECRUITING

Central Study Contacts

Linda Morgan

CONTACT

317-274-2745; lismorga@iupui.edu

Michele Spriggs

CONTACT

317-274-2745; mmmcpher@iupui.edu

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 23, 2020
• First Posted: January 8, 2021
• Study Start: December 17, 2020
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: October 23, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)