Observational Study of Iris Tumors

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03809585

Enrollment

100

Registered

2019-01-18

Start date

2018-06-20

Completion date

2027-12-31

Last updated

2025-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Iris Tumor

Keywords

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

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Tumor Thickness in Benign vs Malignant Iris Lesions	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

Measure	Time frame	Description
Tumor Area in Benign vs Malignant Iris Lesions	6 months	Tumor area will be measured by OCT/OCTA in mm2 and compared against conventional UBM measurements.
Tumor Volume in Benign vs Malignant Iris Lesions	6 months	Tumor volume will be measured by OCT/OCTA in mm3 and compared against conventional UBM measurements.
Effect of Radiation Treatment on Tumor and Surrounding Ocular Structures	6 months after treatment	Vessel density and tortuosity will both be measured in % occupied by flow pixels on OCT/OCTA.

Countries

United States

Contacts

Primary ContactDenzil Romfh, OD

romfhd@ohsu.edu503-494-4351

Backup ContactHumberto Martinez, COT

martinhu@ohsu.edu503-494-7712

Outcome results