Observational Study of Iris Tumors

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StatusRecruiting

Keywords

neoplasms

Abstract

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.

Dates

Last Verified:	01/31/2020
First Submitted:	11/28/2018
Estimated Enrollment Submitted:	01/15/2019
First Posted:	01/17/2019
Last Update Submitted:	02/02/2020
Last Update Posted:	02/04/2020
Actual Study Start Date:	06/19/2018
Estimated Primary Completion Date:	11/30/2023
Estimated Study Completion Date:	11/30/2023

Condition or disease

Iris Tumor

Phase

Arm Groups

Arm	Intervention/treatment
Iris Tumors This group will consist of 50 adults age 18 or older who have been diagnosed with either melanotic or amelanotic iris tumors. Iris tumor diagnosis will be confirmed by biopsy when possible or based upon clinical features (if patient declines biopsy or if not medically indicated) according to standard-of-care guidelines.
Healthy Controls This group will consist of 50 adults age 18 and older who have healthy eyes.

Eligibility Criteria

Ages Eligible for Study	18 Years To 18 Years
Sexes Eligible for Study	All
Sampling method	Non-Probability Sample
Accepts Healthy Volunteers	Yes
Criteria	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

Outcome

Primary Outcome Measures

1. Tumor Thickness in Benign vs Malignant Iris Lesions [6 months]

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.

Secondary Outcome Measures

1. Tumor Area in Benign vs Malignant Iris Lesions [6 months]

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

2. Tumor Volume in Benign vs Malignant Iris Lesions [6 months]

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

3. Effect of Radiation Treatment on Tumor and Surrounding Ocular Structures [6 months after treatment]

Vessel density and tortuosity will both be measured in % occupied by flow pixels on OCT/OCTA.