ClinicalTrials.gg
RecruitingNCT02141308Updated Feb 12, 2024

OCT in Rare Chorioretinal Diseases

An observational study in Retinal Artery Occlusions, Polypoidal Choroidal Vasculopathy and Retinal Arterial Macroaneurysm, sponsored by Oregon Health and Science University. Recruiting at 1 site in United States. Open to participants aged 7 Years to 100 Years. Per ClinicalTrials.gov, last updated 2024-02-12.

Sponsored by Oregon Health and Science University · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2025, 11 months ago, but the record still lists the study as recruiting.
  • Started May 2014; still recruiting 12 years 6 months later.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
150
Ages
7 Years to 100 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

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

Keywords

  • Retina
  • Optical coherence tomography
  • Imaging
03

In context

Retinal Artery Occlusion

31 studies on the registry are indexed under Retinal Artery Occlusion; 7 are open to participants now.

This study's planned enrollment of 150 is below the median of 388 across 14 observational studies indexed under Retinal Artery Occlusion.

Browse Retinal Artery Occlusion studies →

Lead sponsor

Oregon Health and Science University is the lead sponsor of 696 studies on the registry; 131 are open to participants now.

Of its 52 completed or terminated interventional studies of FDA-regulated products, 39 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
7 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No
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.

Eligibility criteria

Subject-Level Criteria:

Inclusion a. Diagnosis of retinal or choroidal disease

Exclusion

  1. Inability to give .
  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 : 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.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
150 participants (estimated)

Groups and cohorts

  • 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: One year

07

Study locations

1 of 1 sites recruiting
  • Casey Eye Institute, Oregon Health & Science University
    Portland, Oregon 97239-3098, United States
    Recruiting
    • Kevin Lathrop · Contactlathropk@ohsu.edu · 503-494-8024
    • Denny Romfh, OD · Contactromfhd@ohsu.edu · 503-494-4351
    • John Campbell, MD, MPH · Sub investigator
    • Andreas Lauer, MD · Sub investigator
    • Christina Flaxel, MD · Sub investigator
    • Michael Klein, MD · Sub investigator
    • Steven Bailey, MD · Sub investigator
    • Eric Suhler, MD · Sub investigator
    • David Huang, MD, PhD · Sub investigator
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 12, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02141308
Responsible party
David Huang (Thomas Hwang, MD, Professor of Ophthalmology, Retina & Vitreous Diseases Division, Oregon Health and Science University) — Principal investigator
First posted
May 19, 2014
Start date
May 2014
Primary completion
Dec 2025 (estimated)
Completion
Dec 2026 (estimated)
Last update
Feb 12, 2024

Study contacts

Kevin Lathrop
Contact
lathropk@ohsu.edu
503-494-8024
Denny Romfh, OD
Contact
romfhd@ohsu.edu
503-494-4351
Thomas Hwang, MD
principal investigator · Oregon Health & Science Univeristy
View the source record on ClinicalTrials.gov ↗

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