Recruiting

Observational Study

Sponsor:

Indiana University

Code:

NCT04700657

Conditions

Ocular GVHD

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

corneal sensation test

Study Details

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

Study ID

NCT04700657

Start date

Dec 17, 2020

Status verified date

Jul, 2026

Completion date

Jun, 2028

Anticipated

Primary completion date

Jun, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

30 participants

Anticipated

Interventions and Outcome Measures

Arms

15 patients affected by ocular GVHD

15 age-matched normal volunteers.

Interventions

corneal sensation test

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

Primary outcome measure

  • Corneal Hypoesthesia [ Time Frame: Baseline clinic visit ]

Central Contacts and Locations

Central contacts

Linda Morgan

317-274-2745lismorga@iupui.edu

Michele Spriggs

317-274-2745mmmcpher@iupui.edu

Locations

Glick Eye Institute - Indiana University

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

Linda Morgan

317-274-2745lismorga@iupui.edu

Michele Spriggs

317-274-2745mmmcpher@iupui.edu

More Information

Sponsor

Indiana University

Last update posted

Aug 12, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-13. This information was provided to ClinicalTrials.gov by Indiana University on 2026-08-12. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.