Iris TumorNCT03809585
Observational Study of Iris Tumors
An observational study of Iris Tumor, run by Oregon Health and Science University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Iris Tumor
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jun 2018to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults age 18 or older with either healthy eyes or iris tumors
Who may be able to join
- Eyes with diagnosis of melanotic or amelanotic iris tumors
- Eyes without iris defects or lesions
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Oregon Health & Science University
Portland, Oregon, 97239
Denzil Romfh, OD, 503-494-4351, romfhd@ohsu.edu
Humberto Martinez, COT, 503-494-7712, martinhu@ohsu.edu
About this study
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
- Keywords
- Iris, Tumor, Melanoma, Optical Coherence Tomography (OCT), Angiography
- Medical subject headings
- Iris Neoplasms, Neoplasms, Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (3)
Tumor Area in Benign vs Malignant Iris Lesions
Tumor area will be measured by OCT/OCTA in mm2 and compared against conventional UBM measurements.
Measured: 6 months
Tumor Volume in Benign vs Malignant Iris Lesions
Tumor volume will be measured by OCT/OCTA in mm3 and compared against conventional UBM measurements.
Measured: 6 months
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.
Measured: 6 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2019
- Study start20 Jun 2018
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iris TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Collaborators
- National Eye Institute (NEI)
- Responsible party
- Principal investigator, David Huang, Oregon Health and Science University
- Investigators
- David Huang, MD, PhD, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03809585
- Sponsor's protocol ID
- 6612-IRIS
- Other IDs
- R01EY028755
- Status last verified
- Sep 2025
- First submitted
- 29 Nov 2018
- Last updated
- 9 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study of Iris Tumors
- ClinicalTrials.gov ID
- NCT03809585
- Acronym / sponsor ID
- 6612-IRIS
- Conditions
- Iris Tumor
- Keywords
- Iris, Tumor, Melanoma, Optical Coherence Tomography (OCT), Angiography
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Collaborators
- National Eye Institute (NEI)
- Study start
- 20 Jun 2018 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 18 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults age 18 or older with either healthy eyes or iris tumors
Key inclusion criteria (2 listed)
- Eyes with diagnosis of melanotic or amelanotic iris tumors
- Eyes without iris defects or lesions
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
3 secondary outcomes
Tumor Area in Benign vs Malignant Iris Lesions
Time frame: 6 months
Tumor Volume in Benign vs Malignant Iris Lesions
Time frame: 6 months
Effect of Radiation Treatment on Tumor and Surrounding Ocular Structures
Time frame: 6 months after treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
David Huang, MD, PhD principal investigator
Oregon Health and Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Iris Tumor, run by Oregon Health and Science University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Denzil Romfh, OD (503-494-4351, romfhd@ohsu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tumor Thickness in Benign vs Malignant Iris Lesions (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2025.