Ocular GVHD Clinical Trial
Official title:
Investigation of the Prevalence of Hypoesthesia Related Neurotrophic Keratitis in Patients With Ocular Graft Versus Host Disease
NCT number | NCT04700657 |
Other study ID # | 2004207079 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | December 17, 2020 |
Est. completion date | December 2024 |
Verified date | August 2023 |
Source | Indiana University |
Contact | Linda Morgan |
Phone | 317-274-2745 |
lismorga[@]iupui.edu | |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Recruiting |
Enrollment | 30 |
Est. completion date | December 2024 |
Est. primary completion date | December 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Glick Eye Institute - Indiana University | Indianapolis | Indiana |
Lead Sponsor | Collaborator |
---|---|
Indiana University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Corneal Hypoesthesia | Corneal Sensation in GVHD compared to healthy age matched controls as measured with Cochet Bonet esthesiometer. | Baseline clinic visit | |
Secondary | dry eye questionnaire, dry eye signs, meibomian gland dysfunction | correlation between corneal hypoesthesia and OSDI questionaire (scale 0-100 points, where higher is worse symptoms)
correlation between corneal hypoesthesia and measure of tear break up time (seconds, where less is worse) correlation between corneal hypoesthesia and bulbar redness (scale 0-4 where higher is worse) correlation between corneal hypoesthesia and tear meniscus height (measured in mm where less than 0.2mm is worse) correlation between corneal hypoesthesia and meibomiography using oculus keratograph ( lower is better) correlation between corneal hypoesthesia and fluorescein staining at slit lamp (NEI scale 0-15 where higher is worse) correlation between corneal hypoesthesia and lissamine green staining (NEI scale 0-8 where higher is worse) correlation between corneal hypoesthesia and schirmer test without anesthesia (measured in mm at 5 minutes where fewer mm of wetting is worse) |
Baseline clinic visit |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT01977781 -
Safety and Efficacy of Topical Tacrolimus 0.05% in the Treatment of Ocular Graft-Versus-Host Disease
|
Phase 1 |