Retinal Vascular DiseaseSWEPTNCT01834196
Swept-Source Optical Coherence Tomography for Noninvasive Retinal Vascular Imaging
A study testing Swept-Source Optical Coherence Tomography in people with Retinal Vascular Disease, run by Duke University at 1 site in United States.
Trial summary
This is a clinical pilot study to assess the feasibility of using a swept-source optical coherence tomography (SSOCT) system to perform noninvasive imaging of the retinal vasculature in patients with existing microvascular disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Retinal Vascular Disease
- What is being tested?
- Swept-Source Optical Coherence Tomography
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2012to Nov 2012
- Phase
- Interventional
- 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
Who may be able to join
- Capable and willing to provide consent
- history of clinically-diagnosed retinal microvascular diseases, including but not limited to diabetic retinopathy, retinal vein occlusion, idiopathic macular telangiectasias, hypertensive retinopathy, and age-related macular degeneration
- At least 18 years of age
Who cannot join
- Unable or unwilling to give consent
- Under 18 years of age
Trial locations and contacts
1 site in 1 country.
About this study
This is a clinical pilot study to assess the feasibility of using a swept-source optical coherence tomography (SSOCT) system to perform noninvasive imaging of the retinal vasculature in patients with existing microvascular disease.
Read the detailed description
This project is being conducted under an abbreviated IDE. Subjects with existing retinal microvascular disease will be recruited from among the patients of the Duke Eye Center and/or its associated satellite clinics. Following informed consent, subjects undergo imaging, per established standard operating procedure, at the Duke University Medical Center/Duke Center or at one of the Duke Eye Center satellite clinics. Pharmacologic dilation of eyes will not be necessary for completion of imaging and will not be used for the purposes of this study. The resulting images will not be used in the clinical care of any of the subjects recruited for this project.
Subjects will be identified from patients presenting for ophthalmologic consultation at the Duke Eye Center and/or its satellite clinic locations.
- Conditions
- Retinal Vascular Disease
- Being tested
- Swept-Source Optical Coherence Tomography
- Keywords
- retinal vascular disease, Swept-Source Ocular Coherence Tomography, SSOCT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Swept-Source Optical Coherence TomographyDevice
Noninvasive imaging of the retinal vasculature in patient with existing microvascular disease.
| Study group | Role | What they receive |
|---|---|---|
| retinal vascular occlusion arm | Other | Patients with existing retinal microvascular disease will undergo imaging. Receives: Device: Swept-Source Optical Coherence Tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
OCT images and metrics derived from the OCT images
Distributions, means, and standard deviations will be reported.
Measured: Day of imaging, approximately 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2013 (estimated)
- Study startAug 2012
- Primary completionNov 2012
- Study completionNov 2012
Why it stopped: No active study enrollment for a 2 years.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retinal Vascular DiseaseStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Prithu Mettu, MD, Principal investigator, Duke Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01834196
- Sponsor's protocol ID
- Pro00038240
- Acronym
- SWEPT
- Status last verified
- Feb 2015
- First submitted
- 15 Apr 2013
- Last updated
- 21 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Swept-Source Optical Coherence Tomography for Noninvasive Retinal Vascular Imaging
- ClinicalTrials.gov ID
- NCT01834196
- Acronym / sponsor ID
- SWEPT / Pro00038240
- Conditions
- Retinal Vascular Disease
- Keywords
- retinal vascular disease, Swept-Source Ocular Coherence Tomography, SSOCT
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: No active study enrollment for a 2 years.
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 17 Apr 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.
This is a clinical pilot study to assess the feasibility of using a swept-source optical coherence tomography (SSOCT) system to perform noninvasive imaging of the retinal vasculature in patients with existing microvascular disease.
Detailed description
This project is being conducted under an abbreviated IDE. Subjects with existing retinal microvascular disease will be recruited from among the patients of the Duke Eye Center and/or its associated satellite clinics. Following informed consent, subjects undergo imaging, per established standard operating procedure, at the Duke University Medical Center/Duke Center or at one of the Duke Eye Center satellite clinics. Pharmacologic dilation of eyes will not be necessary for completion of imaging and will not be used for the purposes of this study. The resulting images will not be used in the clinical care of any of the subjects recruited for this project.
Subjects will be identified from patients presenting for ophthalmologic consultation at the Duke Eye Center and/or its satellite clinic locations.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| retinal vascular occlusion arm | Other | Device: Swept-Source Optical Coherence TomographyPatients with existing retinal microvascular disease will undergo imaging. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Capable and willing to provide consent
- history of clinically-diagnosed retinal microvascular diseases, including but not limited to diabetic retinopathy, retinal vein occlusion, idiopathic macular telangiectasias, hypertensive retinopathy, and age-related macular degeneration
- At least 18 years of age
Key exclusion criteria (2 listed)
- Unable or unwilling to give consent
- Under 18 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Swept-Source Optical Coherence TomographyNoninvasive imaging of the retinal vasculature in patient with existing microvascular disease. | Device | retinal vascular occlusion arm |
Primary outcome
OCT images and metrics derived from the OCT images
Time frame: Day of imaging, approximately 1 hour
Distributions, means, and standard deviations will be reported.
Results and safety
The study was stopped early (reason given: No active study enrollment for a 2 years.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2017.
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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.
Prithu Mettu, MD principal investigator
Duke Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Swept-Source Optical Coherence Tomography in people with Retinal Vascular Disease, run by Duke 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 3 inclusion and 2 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: stopped early, as of the sponsor's last update on 21 Mar 2017. 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 was stopped early (reason given: No active study enrollment for a 2 years.). Results are not available in the source record.
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?
OCT images and metrics derived from the OCT images (time frame: Day of imaging, approximately 1 hour). 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 21 Mar 2017.