Clinical trial NCT02141308: OCT in Rare Chorioretinal Diseases
Official title: Evaluation of the Utility of OCT Angiography in Assessing Vascular Perfusion in Rare Retinal and Choroidal Diseases
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Retinal Artery Occlusions
Polypoidal Choroidal Vasculopathy
Retinal Arterial Macroaneurysm
Juxtafoveal Telangiecasia
Central Serous Chorioretinopathy
Keywords: Retina
Optical coherence tomography
Imaging
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
First posted: 2014-05-19
Enrollment: 150
Sex: ALL
Minimum age (years): 7
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

Detailed description: 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.

Eligibility criteria: Subject-Level Criteria:

Inclusion a. Diagnosis of retinal or choroidal disease

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.

Primary outcomes:
measure: Total Retinal and Choroidal Blood Flow
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Portland
country: United States
facility: Casey Eye Institute, Oregon Health & Science University
state: Oregon
Study officials:
affiliation: Oregon Health & Science Univeristy
name: Thomas Hwang, MD
role: PRINCIPAL_INVESTIGATOR
References: