NCT04700657 The Prevalence of Hypoesthesia Related Keratitis in Ocular Graft Vs. Host Disease (GVHD) Patients
| NCT ID | NCT04700657 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Indiana University |
| Condition | Ocular GVHD |
| Study Type | OBSERVATIONAL |
| Enrollment | 30 participants |
| Start Date | 2020-12-17 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 30 participants in total. It began in 2020-12-17 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04700657 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Ocular GVHD. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04700657 currently recruiting?
Yes, NCT04700657 is actively recruiting participants. Contact the research team at lismorga@iupui.edu for enrollment information.
Where is the NCT04700657 trial being conducted?
This trial is being conducted at Indianapolis, United States.
Who is sponsoring the NCT04700657 clinical trial?
NCT04700657 is sponsored by Indiana University. The trial plans to enroll 30 participants.