Recruiting

Ocular Surface Disease

Sponsor:

University of Maryland, Baltimore

Code:

NCT04946721

Conditions

Dry Eye Disease

oGVHD

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

The standard care exam and biological specimens' collection

Study Details

Brief summary:

Evaluate and study the immunologic changes to the ocular surface in cancer patients.

Conditions

Dry Eye Disease

oGVHD

Study ID

NCT04946721

Start date

Apr 27, 2022

Status verified date

Jan, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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)

Study Design

Enrollment

150 participants

Anticipated

Interventions and Outcome Measures

Arms

1.BMT Patients (Study)

Patients prior to receiving a bone marrow transplant will be recruited during their initial intake prior to their BM transplant through the PI's regularly scheduled appointment with these patients.

2.Controls

Patients with no history of eye disease or cancer history

Interventions

The 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.

Primary outcome measure

  • 1. Risk factors and markers for developing eye diseases [ Time Frame: Up to 4 years ]
  • 2. The mechanisms of eye damage [ Time Frame: Up to 4 years ]
  • The drug acting targets [ Time Frame: Up to 4 years ]
  • The effect of ocular Graft-vs-Host Disease on the eye [ Time Frame: Up to 4 years ]

Central Contacts and Locations

Central contacts

Sarah B Sunshine, MD

667-214-1292ssunshine@som.umaryland.edu

Patricia Lesho

410-328-2577plesho@umm.edu

Locations

Geenebaum Cancer Center, University of Maryland Medical Center

Recruiting

Baltimore, Maryland, United States, 21201

Contacts

Patricia Lesho

410-328-2577plesho@umm.edu

More Information

Sponsor

University of Maryland, Baltimore

Last update posted

Feb 3, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-03. This information was provided to ClinicalTrials.gov by University of Maryland, Baltimore on 2026-02-03. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.