Ocular Complications from Cancer Therapy - Patient Registry and Biobank

This study is creating a registry and biobank to understand eye problems that can happen after cancer treatment. Researchers will collect information and samples from people who have had cancer therapy, including those who received an allogeneic hematopoietic stem cell transplant (HSCT) or other cancer treatments. The goal is to learn more about conditions like Graft Versus Host Disease (GVHD) in the eye and inflammatory dry eye disease. You would have an eye exam, and researchers would gather your medical history, including past medications and eye conditions. The main goal is to use a scoring system to measure the severity of chronic ocular GVHD, with measurements taken at the time of your eye exam, typically between 3 months and 10 years after transplant. This is an observational study, meaning you won't receive a new treatment, but your information will help researchers understand these eye complications better.

Study design: This is an observational study that plans to enroll 150 adult participants. It is not randomized or blinded.
What's involved: You would participate by having an eye exam, during which your medical and ocular history would be collected. Biological samples like eye washes or blood may also be collected.
Compensation: Not stated in the trial record.
Follow-up: The primary endpoint, the International Chronic Ocular Graft Versus Host Disease Severity Score, will be measured at the time of your eye exam, which can be up to 10 years post-transplant.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

Ocular Complications From Cancer Therapy - Patient Registry and Biobank

Recruiting

Not specifiedAges 18+Observational

University of Maryland, Baltimore

~150 participants

Updated 2026-03-05 on ClinicalTrials.gov

What's tested:Eye exam

At a glance

Recruiting sites

1 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

International Chronic Ocular Graft Versus Host Disease Severity Score

Measured over 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.

Conditions

Graft Versus Host Disease in Eye

Ocular Complications

Inflammatory Dry Eye Disease

Where it's being run

1 sites across 1 states

Maryland1

Who to contact

Sarah Sunshine, MD

[email protected]

667-214-1292

Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.

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

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).

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.

What this trial measures

International Chronic Ocular Graft Versus Host Disease Severity ScoreAt 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.
The International Chronic oGVHD severity score (Ogawa, Y. et al. International Chronic Ocular Graft-vs-Host-Disease (GVHD) Consensus Group: Proposed Diagnostic Criteria for Chronic GVHD (Part I). Sci Rep 3, 3419 (2013). https://doi.org/10.1038/srep03419) is the standard of care for diagnosing and monitoring ocular GvHD. Briefly, this is calculated based on the sum of the patient's Schirmer's severity score (range of 0-3), OSDI severity score (range of 0-3), corneal fluorescein staining severity score (range of 0-3), and conjunctival injection severity score (range of 0-2). This sum ranges from 0 to 11. To diagnose whether a patient has no oGVHD, probable oGVHD, or definite oGVHD, there are two separate scales depending on whether the patient has systemic GVHD or not. Based on the sum of the characteristics, one can diagnose whether or not the patient has oGVHD. Patients are categorized into None, Probable or Definite and the criteria is different based on their systemic GvHD status.

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