Actively Recruiting

Age: 18Years +
All Genders
Healthy Volunteers
NCT04700657

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

Led by Indiana University · Updated on 2025-10-23

30

Participants Needed

1

Research Sites

362 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 years or older
  • Diagnosis of chronic GVHD based on history of allogeneic HSCT and systemic GVHD in organs other than the eye
  • In ocular GVHD patients, dry eye symptoms started after systemic GVHD development; if dry eye started earlier, diagnosis based on 2013 International chronic ocular GVHD criteria
  • Ocular GVHD patients must have typical dry eye symptoms with Ocular Surface Disease Index (OSDI) score greater than 13
  • Corneal fluorescein staining (CFS) score of 3 or more on the National Eye Institute (NEI) grading scale (0-15)
  • Normal control group includes age-matched volunteers with OSDI score 13 or less and CFS score less than 3
  • Patients may continue current systemic and ocular medications such as preservative-free artificial tears, Restasis, Xiidra, serum tears, ointment, or scleral contact lens
Not Eligible

You will not qualify if you...

  • History of herpetic simplex or zoster keratitis
  • History of ocular or neurologic surgery (including laser or refractive surgery) within 3 months before enrollment
  • History of eye trauma
  • Diabetes with signs of peripheral neuropathy
  • Active corneal thinning or infection

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Glick Eye Institute - Indiana University

Indianapolis, Indiana, United States, 46202

Actively Recruiting

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Research Team

L

Linda Morgan

CONTACT

M

Michele Spriggs

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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