Skip to main content
OpenTrials
Recruiting

NCT Number: NCT03809585

Observational Study of Iris Tumors

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Iris Tumor Eye Diseases Eye Neoplasms Iris Diseases Iris Neoplasms Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases Uveal Diseases Uveal Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Denzil Romfh, OD

CONTACT

[email protected]

503-494-4351

Humberto Martinez, COT

CONTACT

[email protected]

503-494-7712

Sponsors and collaborators

Lead sponsor

Oregon Health and Science University

Other

Collaborators

  • National Eye Institute (NEI)

Registry information

Important dates

Study start
2018
Primary completion
2026
Study completion
2027
First posted
Jan 18, 2019
Registry last updated
Sep 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.