Ocular Complications From Cancer Therapy - Patient Registry and Biobank

Conditions

• Graft Versus Host Disease in Eye
• Inflammatory Dry Eye Disease
• Ocular Complications

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Accepted

Interventions

• Eye exam — PROCEDURE
  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.

Study Details

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.

Key Dates

Start date

May 13, 2025

Status verified

Mar 2026

Primary completion

Apr 30, 2031

Completion

Apr 30, 2031

Study Design

Enrollment

150 participants (estimated)

Arms

• Arm: Cancer Therapy
  The intervention administered will be the eye exam and research protocols (e.g. tear collection, impression cytology, and blood collection)
• Arm: Control
  The intervention administered will be the standard of care procedures of the eye exam.

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

• Sarah Sunshine, MD
  667-214-1292
  [email protected]

Locations (1)

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