Observational Study of Iris Tumors

Recruiting

• Conditions: Iris Tumor

• Registration Number: NCT03809585
• Lead Sponsor: Oregon Health and Science University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-06-20
• Study First Submitted: 2018-11-29
• Study First Submitted QC: 2019-01-16
• Study First Posted: 2019-01-18
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-08
• Last Update Posted: 2024-02-12
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
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.
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.

Trial Locations

Locations (1)

Oregon Health & Science University; 🇺🇸 Portland, Oregon, United States