Recruiting NCT03809585
Observational Study of Iris Tumors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Iris Tumor. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Primary outcome measures
- Tumor Thickness in Benign vs Malignant Iris Lesions [Time frame: 6 months]
Secondary outcome measures (3)
- 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]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Case-control
Study locations
United States · 1 center
- Oregon Health & Science University — Portland
Identifiers
NCT: NCT03809585 · 6612-IRIS · R01EY028755