OCT in Rare Chorioretinal Diseases

Central Serous Chorioretinopathy Clinical Trial

Official title:

Evaluation of the Utility of OCT Angiography in Assessing Vascular Perfusion in Rare Retinal and Choroidal Diseases

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02141308
• Other study ID #: IRB00010511
• Status: Recruiting
• Start date: May 2014
• Est. completion date: December 2026

Study information

• Verified date: February 2024
• Source: Oregon Health and Science University
• Contact: Kevin Lathrop
• Phone: 503-494-8024
• Email: lathropk[@]ohsu.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 2026
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
United States	Casey Eye Institute, Oregon Health & Science University	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Oregon Health and Science University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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