Recruiting

Observational Study

Sponsor:

University of Maryland, Baltimore

Code:

NCT06874283

Conditions

Graft Versus Host Disease in Eye

Ocular Complications

Inflammatory Dry Eye Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Eye exam

Study Details

Brief summary:

The purpose of this study is to collect data on patients seen at University of Maryland after undergoing cancer therapy. Previous medications, ocular history, medical history, clinical evaluations, surgical procedures and outcomes will be gathered on the patients who consent to participate. Potential subjects will be enrolled from the clinical practice of the investigator at the time of their eye examination visit. A standard of care exam will be performed pertinent to the reason for the visit. In addition to the standard of care exam, certain biological specimens (ocular surface wash, mucocellular material, corneal filaments, impression cytology, and/or blood) will be collected, stored, and analyzed to obtain immunologic, cellular, or molecular mechanistic insights into disease pathogenesis.

Conditions

Graft Versus Host Disease in Eye

Ocular Complications

Inflammatory Dry Eye Disease

Study ID

NCT06874283

Start date

May 13, 2025

Status verified date

Mar, 2026

Completion date

Apr, 2031

Anticipated

Primary completion date

Apr, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria for the Cancer Therapy Group:

  • Adult patients (greater than 18 years of age)
  • Deny a history of eye diseases (excluding cataract, glaucoma, mild dry eye disease, or history of cataract or refractive surgery)
  • Patients who have a history of allogenic HSCT with all stem cell sources including bone marrow, PBSC, cord AND/OR patients with a history of prior cancer therapy including BMT, chemotherapy, and immunotherapy
  • Patients will be recruited after their HSCT or cancer therapy at their ophthalmology appointment
  • Patients can be included with a history of prior cancer therapy including chemotherapy, BMT, immunotherapy. Prior cancer therapy must be identified and documented.
  • The patient must be able to understand and sign and date the informed consent form approved by the IRB.

Inclusion Criteria for the Control Group:

  • No history of cancer or cancer therapy in the past
  • Adult patients (greater than 18 years of age)
  • Deny a history of eye diseases (excluding cataract, glaucoma, mild dry eye disease, or history of cataract or refractive surgery)
  • The patient must be able to understand and sign and date the informed consent form approved by the IRB.

Exclusion Criteria for the Cancer Therapy Group:

  • Vulnerable populations: neonates, children, prisoners, institutionalized individuals
  • Inability or refusal to provide informed consent.
  • History of ocular surgery or ocular disease (except refractive or cataract surgery, mild dry eye disease, or glaucoma).

Exclusion Criteria for the Control Group:

  • Vulnerable populations: neonates, children, prisoners, institutionalized individuals
  • Inability or refusal to provide informed consent.
  • History of ocular surgery or ocular disease (except refractive or cataract surgery, mild dry eye disease, or glaucoma).
  • History of cancer or cancer therapy including chemotherapy, immunotherapy, BMT.

Study Design

Enrollment

150 participants

Anticipated

Interventions and Outcome Measures

Arms

Cancer Therapy

The intervention administered will be the eye exam and research protocols (e.g. tear collection, impression cytology, and blood collection)

Control

The intervention administered will be the standard of care procedures of the eye exam.

Interventions

Eye exam

Previous medications, ocular history, medical history, clinical evaluations, surgical procedures and outcomes will be gathered on the patients who consent to participate. A standard of care exam will be performed to the reason for the visit. In addition to the standard of care exam, those in the Cancer Therapy arm will have certain biological samples (tear collection, impression cytology, and/or blood) collected, stored, and analyzed so we may obtain immunologic, cellular, or molecular mechanistic insights into disease pathogenesis.

Primary outcome measure

  • International Chronic Ocular Graft Versus Host Disease Severity Score [ Time Frame: At the time of intervention (eye exam), between on average 3 months to 5 years post-transplant, but this can also extend up to 10 years post-transplant. The expected average will be 3 years post-transplant. ]

Central Contacts and Locations

Central contacts

Sarah Sunshine, MD

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

Locations

Stoler Outpatient Cancer Center at the University of Maryland

Recruiting

Baltimore, Maryland, United States, 21201

Contacts

Sarah Sunshine, MD

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

More Information

Sponsor

University of Maryland, Baltimore

Last update posted

Mar 5, 2026

Last verified

Mar, 2026

Keywords

  • ocular graft versus host disease
  • allogenic stem cell transplant
  • blood cancer
  • ocular complications
  • inflammatory dry eye disease
  • ocular surface disease

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Maryland, Baltimore on 2026-03-05.