Iris Tumor Clinical Trial
Official title:
Observational Study of Iris Tumors
This is an observational study using OCT angiography to assist with tumor characterization in melanotic and amelanotic iris lesions. OCT angiography data from healthy eyes will be compared to eyes with various types of iris tumors.
| Status | Recruiting |
| Enrollment | 100 |
| Est. completion date | December 2025 |
| Est. primary completion date | December 2025 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria for tumor group: - Eyes with diagnosis of melanotic or amelanotic iris tumors Inclusion Criteria for healthy control group: - Eyes without iris defects or lesions Exclusion Criteria (both groups): - Inability to give informed consent - Inability to maintain stable fixation for OCT imaging - Inability to commit to required study visits - Eyes with concurrent retinal diseases, glaucoma, or conditions that in the opinion of the investigators might affect iris circulation - Mature cataracts if found to limit visual potential to worse than 20/40 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Oregon Health & Science University | Portland | Oregon |
| Lead Sponsor | Collaborator |
|---|---|
| Oregon Health and Science University | National Eye Institute (NEI) |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Tumor Thickness in Benign vs Malignant Iris Lesions | OCT/OCTA will be used to compare tumor thickness measurements against the conventional Ultrasonic Biomicroscopy (UBM) device. Tumor thickness will be measured in millimeters, and growth of 0.5 mm or greater will be used to differentiate malignant from benign lesions. | 6 months | |
| Secondary | Tumor Area in Benign vs Malignant Iris Lesions | Tumor area will be measured by OCT/OCTA in mm2 and compared against conventional UBM measurements. | 6 months | |
| Secondary | Tumor Volume in Benign vs Malignant Iris Lesions | Tumor volume will be measured by OCT/OCTA in mm3 and compared against conventional UBM measurements. | 6 months | |
| Secondary | Effect of Radiation Treatment on Tumor and Surrounding Ocular Structures | Vessel density and tortuosity will both be measured in % occupied by flow pixels on OCT/OCTA. | 6 months after treatment |