Observational Study of Iris Tumors

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Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	Yes
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT03809585
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Oregon Health and Science University
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	David Huang, MD, PhD
Principal Investigator Affiliation	Oregon Health and Science University
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other, NIH
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Iris Tumor

Arms & Interventions

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.

Interventions

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Oregon Health & Science University, Portland 5746545, Oregon 5744337

Status

Recruiting

Address

Oregon Health & Science University

Portland 5746545, Oregon 5744337, 97239

Site Contact

Denzil Romfh, OD

[email protected]

503-494-4351