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Observational Study of Iris Tumors

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ClinicalTrials.gov Identifier: NCT03809585
Recruitment Status : Recruiting
First Posted : January 18, 2019
Last Update Posted : March 26, 2021
Sponsor:
Collaborator:
National Eye Institute (NEI)
Information provided by (Responsible Party):
David Huang, Oregon Health and Science University

Study Description
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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.

Condition or disease
Iris Tumor

Study Design
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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Observational Study of Iris Tumors
Actual Study Start Date : June 20, 2018
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Tumor Area in Benign vs Malignant Iris Lesions [ Time Frame: 6 months ]
    Tumor area will be measured by OCT/OCTA in mm2 and compared against conventional UBM measurements.

  2. Tumor Volume in Benign vs Malignant Iris Lesions [ Time Frame: 6 months ]
    Tumor volume will be measured by OCT/OCTA in mm3 and compared against conventional UBM measurements.

  3. Effect of Radiation Treatment on Tumor and Surrounding Ocular Structures [ Time Frame: 6 months after treatment ]
    Vessel density and tortuosity will both be measured in % occupied by flow pixels on OCT/OCTA.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Adults age 18 or older with either healthy eyes or iris tumors
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03809585


Contacts
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Contact: Denzil Romfh, OD 503-494-4351 romfhd@ohsu.edu
Contact: Humberto Martinez, COT 503-494-7712 martinhu@ohsu.edu

Locations
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United States, Oregon
Oregon Health & Science University Recruiting
Portland, Oregon, United States, 97239
Contact: Denzil Romfh, OD    503-494-4351    romfhd@ohsu.edu   
Contact: Humberto Martinez, COT    503-494-7712    martinhu@ohsu.edu   
Sponsors and Collaborators
Oregon Health and Science University
National Eye Institute (NEI)
Investigators
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Principal Investigator: David Huang, MD, PhD Oregon Health and Science University
More Information
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Responsible Party: David Huang, Peterson Professor of Ophthalmology & Professor of Biomedical Engineering, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT03809585    
Other Study ID Numbers: 6612-IRIS
R01EY028755 ( U.S. NIH Grant/Contract )
First Posted: January 18, 2019    Key Record Dates
Last Update Posted: March 26, 2021
Last Verified: March 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by David Huang, Oregon Health and Science University:
Iris
Tumor
Melanoma
Optical Coherence Tomography (OCT)
Angiography
Additional relevant MeSH terms:
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Iris Neoplasms
Neoplasms
Uveal Neoplasms
Eye Neoplasms
 Neoplasms by Site
Eye Diseases
Iris Diseases
Uveal Diseases