TFOS DEWS II Definition and Classification Report.
Jennifer P Craig, Kelly K Nichols, Esen K Akpek...
https://pubmed.ncbi.nlm.nih.gov/28736335Actively Recruiting
Age: 18Years +
All Genders
Healthy Volunteers
ID04946721
Identifying Novel Treatment Targets and Biomarkers for Ocular Surface Disease in Patients With Ocular Graft vs Host Disease a Biobank Study
Led by University of Maryland, Baltimore · Updated on 2026-02-03
150
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the immunologic changes on the surface of the eye in cancer patients, focusing especially on those with ocular graft-versus-host disease (oGVHD). This observational, natural history study aims to understand risk factors, mechanisms of eye damage, drug targets, and effects of oGVHD on the eye over a period of up to four years. Two groups will participate: cancer patients scheduled for bone marrow transplant, who will be evaluated every three months for two years, and healthy control patients without eye disease or cancer history, who will be evaluated every six months. During each visit, standard eye exams will be performed alongside collection of biological specimens such as ocular surface wash, mucocellular material, corneal filaments, impression cytology of conjunctiva, blood, or serum. Participants will attend periodic study visits for clinical exams and specimen collection while receiving their usual care. Researchers will assess various factors including eye disease risk, mechanisms of eye damage, and ocular effects of graft-versus-host disease. The study involves repeated evaluations and biological sampling to track changes over time, with a maximum follow-up of four years.
CONDITIONS
Brief Title
2177GCCC:ID'Ing tx Targets and Biomarkers for Ocular Surface Disease in Pt w/ oGVHD
Who Can Participate
Age: 18Years +
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- 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.
You will not qualify if you...
- Vulnerable populations: neonates, children, prisoners, institutionalized individuals.
- Inability or refusal to provide informed consent.
- History of ocular surgery (except refractive surgery or cataract surgery).
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Long-term Monitoring
Duration - Up to 4 years
Participants are observed over time with regular evaluations and biological specimen collections to study immunologic changes to the ocular surface.
Every 3 months for up to 2 years for pre-bone marrow transplant patients; every 6 months for normal control patients
Trial Site Locations
Total: 1 location
1
Geenebaum Cancer Center, University of Maryland Medical Center
Baltimore, Maryland, United States, 21201
Actively Recruiting
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Research Team
S
Sarah B Sunshine, MD
P
Patricia Lesho
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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Published Research Related To This Trial
TFOS DEWS II pathophysiology report.
Anthony J Bron, Cintia S de Paiva, Sunil K Chauhan...
https://pubmed.ncbi.nlm.nih.gov/28736340Ocular surface extracellular DNA and nuclease activity imbalance: a new paradigm for inflammation in dry eye disease.
Snehal Sonawane, Vishakha Khanolkar, Abed Namavari...
https://pubmed.ncbi.nlm.nih.gov/23169882New insight into dry eye inflammation.
Alison M McDermott
https://pubmed.ncbi.nlm.nih.gov/23248237Neutrophil extracellular traps kill bacteria.
Volker Brinkmann, Ulrike Reichard, Christian Goosmann...
https://pubmed.ncbi.nlm.nih.gov/15001782Neutrophil extracellular traps as a new paradigm in innate immunity: friend or foe?
Paul R Cooper, Lisa J Palmer, Iain L C Chapple
https://pubmed.ncbi.nlm.nih.gov/23931060Tear fluid extracellular DNA: diagnostic and therapeutic implications in dry eye disease.
Sapna Tibrewal, Joy Sarkar, Sarmad H Jassim...
https://pubmed.ncbi.nlm.nih.gov/24255046Dry eye after haematopoietic stem cell transplantation.
Y Ogawa, S Okamoto, M Wakui...
https://pubmed.ncbi.nlm.nih.gov/10502571National Institutes of Health Consensus Development Project on Criteria for Clinical Trials in Chronic Graft-versus-Host Disease: I. The 2014 Diagnosis and Staging Working Group report.
Madan H Jagasia, Hildegard T Greinix, Mukta Arora...
https://pubmed.ncbi.nlm.nih.gov/25529383Ocular graft-versus-host disease after hematopoietic cell transplantation: Expert review from the Late Effects and Quality of Life Working Committee of the CIBMTR and Transplant Complications Working Party of the EBMT.
Yoshihiro Inamoto, Nuria Valdés-Sanz, Yoko Ogawa...
https://pubmed.ncbi.nlm.nih.gov/30531954