Recruiting

OCT

Sponsor:

Oregon Health and Science University

Code:

NCT02141308

Conditions

Retinal Artery Occlusions

Polypoidal Choroidal Vasculopathy

Retinal Arterial Macroaneurysm

Juxtafoveal Telangiecasia

Central Serous Chorioretinopathy

Eligibility Criteria

Sex: All

Age: 7 - 70+

Healthy Volunteers: Not accepted

Study Details

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

Study ID

NCT02141308

Start date

May, 2014

Status verified date

Feb, 2024

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 7 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

150 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Primary outcome measure

  • Total Retinal and Choroidal Blood Flow [ Time Frame: One year ]

Central Contacts and Locations

Central contacts

Locations

Casey Eye Institute, Oregon Health & Science University

Recruiting

Portland, Oregon, United States, 97239-3098

Contacts

More Information

Sponsor

Oregon Health and Science University

Last update posted

Feb 12, 2024

Last verified

Feb, 2024

Keywords

  • Retina
  • Optical coherence tomography
  • Imaging

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Oregon Health and Science University on 2024-02-12.