OCT in Rare Chorioretinal Diseases

NCT02141308 | Recruiting

• 1 other identifier: IRB00010511
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate the total blood flow in the retina and choroid (structures in the back of the eye) by Doppler optical coherence tomography (OCT) and OCT angiography. Angiography is mapping of the blood vessels. The purpose of measuring blood flow in the retina and choroid is to 1.) determine if rare diseases in these structures causes a change in blood flow compared to healthy eyes and 2.) find out if areas of changed blood flow line up with areas of damage that appear on conventional testing.

Conditions

Retinal Artery Occlusions; Polypoidal Choroidal Vasculopathy; Retinal Arterial Macroaneurysm; Juxtafoveal Telangiecasia; Central Serous Chorioretinopathy

Keywords

Retina; Optical coherence tomography; Imaging

Outcome Measures

Primary Outcomes (1)

• Total Retinal and Choroidal Blood Flow

  Determination whether disease affecting the retina and/or choroid shows a change in blood flow that differs from healthy eyes. Total retinal/choroidal blood flow will be measured in uL/min.

  One year

Study Arms (1)

Rare Chorioretinal Disease

Up to 150 patients diagnosed with a rare retinal or choroidal disease will be considered and evaluated for enrollment in this study.

Eligibility Criteria

• Age: 7 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Individuals 18 years of age and older presenting to the Retina Service within the Department of Ophthalmology at the Casey Eye Institute of Oregon Health \& Science University with signs and symptoms of rare choroidal or retinal diseases will be evaluated for enrollment into this study.

You may not qualify if:

• Inability to give informed consent.
• Inability to complete study tests within a 30 day period
• Significant renal disease, defined as a history of chornic renal failure requiring dialysis or kidney transplant.
• A condition that, in the opinion of the investigator, would preclude participation in the study (e.g. unstable medical status including blood pressure, cardiovascular disease, and glycemic control).
• Blood pressure \> 180/110 (systolic above 180 OR diastolic above 110). If blood pressure is brought below 180/110 by anti-hypertensive treatment, subject can become eligible.
• Women of child-bearing potential: pregnant or lactating or intending to become pregnant within the next 12 months due to unknown safety of fluorescein angiography.
• Study-Eye Criteria:
• a. Diagnosis of retinal or choroidal disease
• Inability to maintain stable fixation for OCT imaging.
• An ocular condition is present that, in the opinion of the investigator, might affect or alter visual acuity during the course of the study (i.e. cataract)
• Substantial cataract that, in the opinion of the investigator, is likely to decrease visual acuity by 3 lines or more (i.e. cataract would be reducing acuity to 20/40 or worse if the eye was otherwise normal).
• Media opacity or otherwise that would prevent either fixation or ability to obtain adequate images as determined by the examiner.

Sponsors & Collaborators

• Oregon Health and Science University: lead

Study Sites (1)

Casey Eye Institute, Oregon Health & Science University

Portland, Oregon, 97239-3098, United States

RECRUITING

MeSH Terms

Conditions

Retinal Artery Occlusion; Polypoidal Choroidal Vasculopathy; Retinal Arterial Macroaneurysm; Central Serous Chorioretinopathy

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Choroidal Neovascularization; Choroid Diseases; Uveal Diseases; Neovascularization, Pathologic; Metaplasia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hypertensive Retinopathy; Aneurysm; Hypertension

Study Officials

• Thomas Hwang, MD

  Oregon Health & Science Univeristy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kevin Lathrop

CONTACT

503-494-8024; lathropk@ohsu.edu

Denny Romfh, OD

CONTACT

503-494-4351; romfhd@ohsu.edu

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Thomas Hwang, MD, Professor of Ophthalmology, Retina & Vitreous Diseases Division

Study Record Dates

• First Submitted: May 15, 2014
• First Posted: May 19, 2014
• Study Start: May 1, 2014
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 12, 2024

Record last verified: 2024-02

Locations

US (1)