Observational Study of Iris Tumors

Oregon Health and Science University100 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

100

Conditions

Iris Tumor

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Oregon Health & Science University

Portland, Oregon, United States

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: 6 months

Secondary Outcomes

Tumor Area in Benign vs Malignant Iris Lesions

Tumor area will be measured by OCT/OCTA in mm2 and compared against conventional UBM measurements.

Time frame: 6 months

Tumor Volume in Benign vs Malignant Iris Lesions

Tumor volume will be measured by OCT/OCTA in mm3 and compared against conventional UBM measurements.

Time frame: 6 months

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.

Time frame: 6 months after treatment

Central Contacts

Denzil Romfh, OD

CONTACT

503-494-4351 romfhd@ohsu.edu

Humberto Martinez, COT

CONTACT

503-494-7712 martinhu@ohsu.edu

Data from ClinicalTrials.gov

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