Recruiting

Observational Study

Sponsor:

Oregon Health and Science University

Code:

NCT03809585

Conditions

Iris Tumor

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Study Details

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.

Conditions

Iris Tumor

Study ID

NCT03809585

Start date

Jun 20, 2018

Status verified date

Sep, 2025

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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 Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Primary outcome measure

  • Tumor Thickness in Benign vs Malignant Iris Lesions [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Denzil Romfh, OD

503-494-4351romfhd@ohsu.edu

Humberto Martinez, COT

503-494-7712martinhu@ohsu.edu

Locations

Oregon Health & Science University

Recruiting

Portland, Oregon, United States, 97239

Contacts

Denzil Romfh, OD

503-494-4351romfhd@ohsu.edu

Humberto Martinez, COT

503-494-7712martinhu@ohsu.edu

More Information

Sponsor

Oregon Health and Science University

Last update posted

Sep 9, 2025

Last verified

Sep, 2025

Keywords

  • Iris
  • Tumor
  • Melanoma
  • Optical Coherence Tomography (OCT)
  • Angiography

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Oregon Health and Science University on 2025-09-09.