Observational Study of Iris Tumors

NCT ID: NCT03809585

Last Updated: 2025-09-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-06-20

Study Completion Date

2027-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Iris Tumor

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

No interventions assigned to this group

Healthy Controls

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

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Eyes with diagnosis of melanotic or amelanotic iris tumors


* Eyes without iris defects or lesions

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Eye Institute (NEI)

NIH

Sponsor Role collaborator

Oregon Health and Science University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

David Huang

Peterson Professor of Ophthalmology & Professor of Biomedical Engineering

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

David Huang, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Oregon Health and Science University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Oregon Health & Science University

Portland, Oregon, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Denzil Romfh, OD

Role: CONTACT

503-494-4351

Humberto Martinez, COT

Role: CONTACT

503-494-7712

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Denzil Romfh, OD

Role: primary

503-494-4351

Humberto Martinez, COT

Role: backup

503-494-7712

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

R01EY028755

Identifier Type: NIH

Identifier Source: secondary_id

View Link

6612-IRIS

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

OCT in Fuchs' Dystrophy
NCT04258787 RECRUITING
Retinal Investigation Using Optos OCT Device
NCT06846151 NOT_YET_RECRUITING NA