Observational Study of Iris Tumors

Oregon Health & Science University (OHSU)

Status: Enrolling

Conditions: Iris Tumor

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT03809585

6612-IRIS

R01EY028755 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

100 participants in 2 patient groups

Iris Tumors

Description:

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

Description:

This group will consist of 50 adults age 18 and older who have healthy eyes.