Retinal Artery OcclusionsNCT02141308
OCT in Rare Chorioretinal Diseases
An observational study of Retinal Artery Occlusions and Polypoidal Choroidal Vasculopathy, run by Oregon Health and Science University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 7 to 100 years
- Conditions the study is for
- Retinal Artery Occlusions, Polypoidal Choroidal Vasculopathy, Retinal Arterial Macroaneurysm
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- May 2014to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- Diagnosis of retinal or choroidal disease
Who cannot join
- Inability to give informed consent.
- Inability to complete study tests within a 30 day period
- Significant renal disease, defined as a history of chornic renal failure requiring dialysis or kidney transplant.
- 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).
- 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.
- 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.
Show all 11Show fewer
- Study-Eye Criteria:
- Inability to maintain stable fixation for OCT imaging.
- 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)
- 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).
- Media opacity or otherwise that would prevent either fixation or ability to obtain adequate images as determined by the examiner.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Casey Eye Institute, Oregon Health & Science University
Portland, Oregon, 97239-3098
Kevin Lathrop, 503-494-8024, lathropk@ohsu.edu
Denny Romfh, OD, 503-494-4351, romfhd@ohsu.edu
About this study
Official title: Evaluation of the Utility of OCT Angiography in Assessing Vascular Perfusion in Rare Retinal and Choroidal Diseases
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.
- Conditions
- Retinal Artery Occlusions, Polypoidal Choroidal Vasculopathy, Retinal Arterial Macroaneurysm, Juxtafoveal Telangiecasia, Central Serous Chorioretinopathy
- Keywords
- Retina, Optical coherence tomography, Imaging
- Medical subject headings
- Retinal Artery Occlusion, Polypoidal Choroidal Vasculopathy, Retinal Arterial Macroaneurysm, Central Serous Chorioretinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2014 (estimated)
- Study startMay 2014
- Primary completionDec 2025 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retinal Artery OcclusionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Huang, Oregon Health and Science University
- Investigators
- Thomas Hwang, MD, Principal investigator, Oregon Health & Science Univeristy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02141308
- Sponsor's protocol ID
- IRB00010511
- Status last verified
- Feb 2024
- First submitted
- 15 May 2014
- Last updated
- 12 Feb 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Utility of OCT Angiography in Assessing Vascular Perfusion in Rare Retinal and Choroidal Diseases
- ClinicalTrials.gov ID
- NCT02141308
- Acronym / sponsor ID
- IRB00010511
- Conditions
- Retinal Artery Occlusions, Polypoidal Choroidal Vasculopathy, Retinal Arterial Macroaneurysm, Juxtafoveal Telangiecasia, Central Serous Chorioretinopathy
- Keywords
- Retina, Optical coherence tomography, Imaging
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- May 2014 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 19 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 7 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Diagnosis of retinal or choroidal disease
Key exclusion criteria (11 listed)
- Inability to give informed consent.
- Inability to complete study tests within a 30 day period
- Significant renal disease, defined as a history of chornic renal failure requiring dialysis or kidney transplant.
- 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).
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Total Retinal and Choroidal Blood Flow
Time frame: One year
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2024.
Related trials for Retinal Artery Occlusions
Not yet recruitingPhase 4
Emerging Indications for Hyperbaric Oxygen Treatment
Post-COVID-19 Condition, Ulcerative Colitis
Recruiting
New Non-invasive Modalities for Assessing Retinal Structure and Function
Ischemic Optic Neuropathy, Branch Retinal Artery Occlusion
RecruitingObservational study
Phenotypic and Etiological Characterization of Susac Syndrome
Susac Syndrome
RecruitingObservational study
Long-term Clinical Outcomes After Retinal Artery Occlusion
Retinal Artery Occlusion
Recruiting
Microneedle Intra-Arterial Injection for Retinal Artery Occlusion
Central Retinal Artery Occlusion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Thomas Hwang, MD principal investigator
Oregon Health & Science Univeristy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Retinal Artery Occlusions and Polypoidal Choroidal Vasculopathy, run by Oregon Health and Science University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kevin Lathrop (503-494-8024, lathropk@ohsu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Retinal and Choroidal Blood Flow (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2024.