Observational Study of Iris Tumors
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|ClinicalTrials.gov Identifier: NCT03809585|
Recruitment Status : Active, not recruiting
First Posted : January 18, 2019
Last Update Posted : January 18, 2019
|Condition or disease|
|Study Type :||Observational|
|Estimated Enrollment :||100 participants|
|Official Title:||Observational Study of Iris Tumors|
|Actual Study Start Date :||June 20, 2018|
|Estimated Primary Completion Date :||December 2023|
|Estimated Study Completion Date :||December 2023|
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.
This group will consist of 50 adults age 18 and older who have healthy eyes.
- Tumor Thickness in Benign vs Malignant Iris Lesions [ Time Frame: 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.
- Tumor Area in Benign vs Malignant Iris Lesions [ Time Frame: 6 months ]Tumor area will be measured by OCT/OCTA in mm2 and compared against conventional UBM measurements.
- Tumor Volume in Benign vs Malignant Iris Lesions [ Time Frame: 6 months ]Tumor volume will be measured by OCT/OCTA in mm3 and compared against conventional UBM measurements.
- Effect of Radiation Treatment on Tumor and Surrounding Ocular Structures [ Time Frame: 6 months after treatment ]Vessel density and tortuosity will both be measured in % occupied by flow pixels on OCT/OCTA.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03809585
|United States, Oregon|
|Oregon Health & Science University|
|Portland, Oregon, United States, 97239|
|Principal Investigator:||David Huang, MD, PhD||Oregon Health and Science University|