Observational Study of Iris Tumors

February 8, 2024 updated by: David Huang, Oregon Health and Science University
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 Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Oregon
      • Portland, Oregon, United States, 97239
        • Recruiting
        • Oregon Health & Science University
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Adults age 18 or older with either healthy eyes or iris tumors

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months
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.
6 months
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.
6 months after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oregon Health and Science University

Collaborators

National Eye Institute (NEI)

Investigators

  • Principal Investigator: David Huang, MD, PhD, Oregon Health and Science University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 20, 2018

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

November 29, 2018

First Submitted That Met QC Criteria

January 16, 2019

First Posted (Actual)

January 18, 2019

Study Record Updates

Last Update Posted (Actual)

February 12, 2024

Last Update Submitted That Met QC Criteria

February 8, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6612-IRIS
  • R01EY028755 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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