Retinal Vein OcclusionsNCT01992575
OCT in Retinal Vein Occlusions
An observational study of Retinal Vein Occlusions, run by Oregon Health and Science University at 1 site in United States.
Trial summary
Retinal blood vessel disease encompasses a wide variety of vision-threatening conditions. Of these conditions, retinal vein occlusions are the most common. Vision loss can occur as a result of macular ischemia (loss of blood flow to the macula) or macular edema (fluid build-up at the macula). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Retinal Vein Occlusions
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to 21 Aug 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study will measure blood vessel pattern/flow changes in up to 35 patients with retinal vein occlusions.
Who may be able to join
- Diagnosis of branch or central retinal vein occlusion
Who cannot join
- Inability to give informed consent
- Inability to complete study tests within a 30 day period from date of enrollment
- Significant renal disease, defined as a history of chronic renal failure requiring dialysis or kidney transplant
- A prior history of reaction to fluorescein or other dyes.
- 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.
Show all 15Show fewer
- Systemic anti-VEGF or pro-VEGF treatment within 4 months prior to treatment.
- 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.
- Prior PRP or focal laser that would alter the macular perfusion and retino-vascular features.
- Inability to maintain fixation for OCT imaging.
- Other ocular condition is present such that, in the opinion of the investigator, may alter the retinal perfusion.
- An ocular condition is present that, in the opinion of the investigator, might affect or alter visual acuity during the course of the study (e.g., 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.
- History of major ocular surgeries (including vitrectomy, cataract extraction, scleral buckle, any intraocular surgery, etc.) within 4 months prior to enrollment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Utility of OCT Angiography in Assessing Vascular Perfusion in Retinal Vein Occlusions
Retinal blood vessel disease encompasses a wide variety of vision-threatening conditions. Of these conditions, retinal vein occlusions are the most common. Vision loss can occur as a result of macular ischemia (loss of blood flow to the macula) or macular edema (fluid build-up at the macula).
OCT is an imaging technology that can perform non-contact cross-sectional imaging of retinal and choroidal tissue structures in real time. It is similar to ultrasound imaging, except that OCT measures the intensity of reflected light rather than sound waves.
The purpose of this study is to see if non-invasive OCT technology can changes due to retinal vein occlusions as well as the more invasive fluorescein angiography, which requires an injection of dye into the vein of an arm of a patient. The study will also compare the mapping of blood vessels (angiography) and loss of blood flow (ischemia) by fluorescein angiography and OCT. These studies will be evaluated to see how they relate to vision loss.
- Conditions
- Retinal Vein Occlusions
- Keywords
- Retinal vein occlusion, OCT, Optical coherence tomography, Imaging
- Medical subject headings
- Retinal Vein Occlusion
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 |
|---|---|---|
| Retinal Vein Occlusion Group | Up to 35 patients diagnosed with retinal vein occlusions 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.
Blood flow patterns and ischemia in retinal vein occlusions
To determine if identifying early changes in blood vessel patterns and ischemia will aid in early diagnosis and treatment of retinal vein occlusions
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2013 (estimated)
- Study startJan 2014
- Primary completion21 Aug 2018
- Study completion21 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retinal Vein 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
- 4 participants (actual)
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
- Phoebe Lin, MD, PhD, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01992575
- Sponsor's protocol ID
- OHSU IRB#00010138
- Status last verified
- Feb 2024
- First submitted
- 19 Nov 2013
- 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 Retinal Vein Occlusions
- ClinicalTrials.gov ID
- NCT01992575
- Acronym / sponsor ID
- OHSU IRB#00010138
- Conditions
- Retinal Vein Occlusions
- Keywords
- Retinal vein occlusion, OCT, Optical coherence tomography, Imaging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- 21 Aug 2018 (actual)
- Study completion
- 21 Aug 2018 (actual)
- First posted
- 25 Nov 2013 (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.
Retinal blood vessel disease encompasses a wide variety of vision-threatening conditions. Of these conditions, retinal vein occlusions are the most common. Vision loss can occur as a result of macular ischemia (loss of blood flow to the macula) or macular edema (fluid build-up at the macula).
OCT is an imaging technology that can perform non-contact cross-sectional imaging of retinal and choroidal tissue structures in real time. It is similar to ultrasound imaging, except that OCT measures the intensity of reflected light rather than sound waves.
The purpose of this study is to see if non-invasive OCT technology can changes due to retinal vein occlusions as well as the more invasive fluorescein angiography, which requires an injection of dye into the vein of an arm of a patient. The study will also compare the mapping of blood vessels (angiography) and loss of blood flow (ischemia) by fluorescein angiography and OCT. These studies will be evaluated to see how they relate to vision loss.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Retinal Vein Occlusion Group | – | –Up to 35 patients diagnosed with retinal vein occlusions will be considered and evaluated for enrollment in this study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study will measure blood vessel pattern/flow changes in up to 35 patients with retinal vein occlusions.
Key inclusion criteria (1 listed)
- Diagnosis of branch or central retinal vein occlusion
Key exclusion criteria (15 listed)
- Inability to give informed consent
- Inability to complete study tests within a 30 day period from date of enrollment
- Significant renal disease, defined as a history of chronic renal failure requiring dialysis or kidney transplant
- A prior history of reaction to fluorescein or other dyes.
- 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).
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
Blood flow patterns and ischemia in retinal vein occlusions
Time frame: 24 months
To determine if identifying early changes in blood vessel patterns and ischemia will aid in early diagnosis and treatment of retinal vein occlusions
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2024.
Related trials for Retinal Vein Occlusions
RecruitingObservational study
National Eye Institute Biorepository for Retinal Diseases
Age-Related Macular Degeneration, Diabetic Retinopathy
Not yet recruitingPhase 4
Iopidine to Decrease Intraocular Pressure Rise After Injections
Macular Degeneration, Diabetic Retinopathy
Recruiting
Robotic RVO Trial: Robot-assisted Retinal Vein Cannulation in Patients With Retinal Vein Occlusions
Retinal Vein Occlusion (RVO)
RecruitingPhase 2
A Dose-masked Study of Intravitreal Remigromig (EYE103) in Participants With NVAMD or Macular Edema Following BRVO
Neovascular Age-Related Macular Degeneration (NVAMD), Branch Retinal Vein Occlusion (BRVO)
Active, not recruitingObservational study
A Real-World Study to Gain Clinical Insights Into Roche Ophthalmology Products
Neovascular Age-related Macular Degeneration, Diabetic Macular Edema
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. This study is not recruiting at the moment.
Phoebe Lin, MD, PhD principal investigator
Oregon Health and Science University
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 Vein Occlusions, 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 15 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: finished, 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood flow patterns and ischemia in retinal vein occlusions (time frame: 24 months). 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.