Dry Eye Disease, oGVHD
Conditions
Brief summary
Evaluate and study the immunologic changes to the ocular surface in cancer patients.
Detailed description
This is a longitudinal natural history study to evaluate and study the immunologic changes to the ocular surface in cancer patients. Two groups of subjects will be recruited for the study: 1) Pre-bone marrow transplant cancer patients. They will be evaluated every 3 months for 2 years.2) Normal control patients. They will be evaluated every 6 months for the duration of the study. During each study visit, in addition to standard of care exams, certain biological specimens ( ocular surface wash, mucocellular material, corneal filaments, or impression cytology of conjunctiva, blood, or serum) will be collected.
Interventions
DIAGNOSTIC_TESTThe standard care exam and biological specimens' collection
During each visit, in addition to standard of care exams, certain biological specimens ( ocular surface wash, mucocellular material, corneal filaments or impression cytology of conjunctiva, blood or serum) will be collected.
Sponsors
University of Maryland, Baltimore
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Adult patients (≥ 18 years of age) who visit the Eye clinic either in the UMGCCC within the UMD Hospital or the UMD Faculty Physicians Ophthalmology Practice at the UMD Professional Building or satellite locations for initial visits or established visits. * The patient must be able to understand and sign and date the informed consent form approved by the IRB.
Exclusion criteria
* Vulnerable populations: neonates, children, prisoners, institutionalized individuals. * Inability or refusal to provide informed consent. * History of ocular surgery (except refractive surgery or cataract surgery)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The effect of ocular Graft-vs-Host Disease on the eye | Up to 4 years | Number of patients who have eye surface changes with Graft-vs-Host Disease during the study |
| 1. Risk factors and markers for developing eye diseases | Up to 4 years | Number of patients with the risks and markers who have developed the eye diseases during the study |
| 2. The mechanisms of eye damage | Up to 4 years | Number of patients who have eye damage during the study |
| The drug acting targets | Up to 4 years | Number of patients who have eye diseases with eye surface changes after the treatment during the study. |
Countries
United States
Contacts
CONTACTSarah B Sunshine, MD
CONTACTPatricia Lesho
PRINCIPAL_INVESTIGATORSarah Sunshine, MD
University of Maryland, Baltimore
Outcome results
None listed