OCT in Rare Chorioretinal Diseases

NCT ID: NCT02141308

Last Updated: 2024-02-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-05-31

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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Optical coherence tomography (OCT) is an imaging technology that can perform non-contact cross-sectional imaging of retinal and choroidal tissue structure in real time by measuring the intensity of reflected light. Tomographic images are generated by scanning the optical probe beam across the tissue structure of interest. OCT has become one of the most widely used imaging technologies by ophthalmologists. Its advantages include being a non-contact imaging modality, having micron-level resolution, producing a digital image that can be viewed electronically, and providing a reproducible quantitative measurement. New functional OCT including Doppler OCT and OCT angiography may allow an assessment of retinal blood flow and do away with the need for the more invasive fluorescein angiography (FA) test.

Thus, if the diagnostic data provided by functional OCT are at least equivalent or superior to those achieved by FA, patients and healthcare providers could realize a substantial benefit in utilizing this technology in the evaluation of retinal vascular disease. Even in the scenario in which an FA is not usually clinically indicated, OCT angiography may provide information over that of standard OCT and clinical examination and history, that might help clinicians better understand the etiology of the disease, and may even help inform treatment response.

Conditions

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

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

Exclusion

1. Inability to give informed consent.
2. Inability to complete study tests within a 30 day period
3. Significant renal disease, defined as a history of chornic renal failure requiring dialysis or kidney transplant.
4. 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).
5. 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.
6. 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:

Inclusion

a. Diagnosis of retinal or choroidal disease

Exclusion

1. Inability to maintain stable fixation for OCT imaging.
2. 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)
3. 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).
4. Media opacity or otherwise that would prevent either fixation or ability to obtain adequate images as determined by the examiner.
Minimum Eligible Age

7 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Oregon Health and Science University

OTHER

Sponsor Role lead

Responsible Party

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David Huang

Thomas Hwang, MD, Professor of Ophthalmology, Retina & Vitreous Diseases Division

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Thomas Hwang, MD

Role: PRINCIPAL_INVESTIGATOR

Oregon Health & Science Univeristy

Locations

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Casey Eye Institute, Oregon Health & Science University

Portland, Oregon, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Kevin Lathrop

Role: CONTACT

503-494-8024

Denny Romfh, OD

Role: CONTACT

503-494-4351

Facility Contacts

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Kevin Lathrop

Role: primary

503-494-8024

Denny Romfh, OD

Role: backup

503-494-4351

Other Identifiers

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IRB00010511

Identifier Type: -

Identifier Source: org_study_id

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