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RecruitingNCT03809585Updated Sep 9, 2025

Observational Study of Iris Tumors

An observational study in Iris Tumor, sponsored by Oregon Health and Science University. Recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-09.

Sponsored by Oregon Health and Science University · Observational

From the registry’s dates

  • Started Jun 2018; still recruiting 8 years 3 months later.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
100
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Iris Tumor

Keywords

  • Iris
  • Tumor
  • Melanoma
  • Optical Coherence Tomography (OCT)
  • Angiography
03

In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's planned enrollment of 100 is below the median of 204 across 1,683 observational studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

Oregon Health and Science University is the lead sponsor of 676 studies on the registry; 136 are open to participants now.

Of its 49 completed or terminated interventional studies of FDA-regulated products, 36 (73%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

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

Eligibility 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
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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.

06

What researchers measure

Primary outcomes

  1. Tumor Thickness in Benign vs Malignant Iris Lesions

    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.

    Time frame: 6 months

Secondary outcomes

  1. Tumor Area in Benign vs Malignant Iris Lesions

    Tumor area will be measured by OCT/OCTA in mm2 and compared against conventional UBM measurements.

    Time frame: 6 months

  2. Tumor Volume in Benign vs Malignant Iris Lesions

    Tumor volume will be measured by OCT/OCTA in mm3 and compared against conventional UBM measurements.

    Time frame: 6 months

  3. Effect of Radiation Treatment on Tumor and Surrounding Ocular Structures

    Vessel density and tortuosity will both be measured in % occupied by flow pixels on OCT/OCTA.

    Time frame: 6 months after treatment

07

Study locations

1 of 1 sites recruiting
  • Oregon Health & Science University
    Portland, Oregon 97239, United States
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 9, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03809585
Lead sponsor
Oregon Health and Science University
Collaborators
National Eye Institute (NEI)
Responsible party
David Huang (Peterson Professor of Ophthalmology & Professor of Biomedical Engineering, Oregon Health and Science University) — Principal investigator
First posted
Jan 18, 2019
Start date
Jun 20, 2018
Primary completion
Dec 2026 (estimated)
Completion
Dec 2027 (estimated)
Last update
Sep 9, 2025

Study contacts

Denzil Romfh, OD
Contact
romfhd@ohsu.edu
503-494-4351
Humberto Martinez, COT
Contact
martinhu@ohsu.edu
503-494-7712
David Huang, MD, PhD
principal investigator · Oregon Health and Science University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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