OCT in Rare Chorioretinal Diseases

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Brief Title

OCT in Rare Chorioretinal Diseases

Official Title

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

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.
    


Study Type

Observational


Primary Outcome

Total Retinal and Choroidal Blood Flow


Condition

Retinal Artery Occlusions


Study Arms / Comparison Groups

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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

150

Start Date

May 2014

Completion Date

December 2022

Primary Completion Date

December 2022

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.
      

Gender

All

Ages

7 Years - 100 Years

Accepts Healthy Volunteers

No

Contacts

Phoebe Lin, MD, PhD, 503-494-8024, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT02141308

Organization ID

IRB00010511


Responsible Party

Principal Investigator

Study Sponsor

Oregon Health and Science University


Study Sponsor

Phoebe Lin, MD, PhD, Principal Investigator, Oregon Health & Science Univeristy


Verification Date

July 2021