Optical Coherence Tomography (OCT) of the RetinaNCT03323307
Low Cost OCT for Point of Care
A study testing OCT imaging in people with Optical Coherence Tomography (OCT) of the Retina, run by Duke University at 1 site in United States.
Trial summary
The purpose of this study is to compare the performance of a prototype optical coherence tomography (OCT) machine with currently available high resolution OCT machines. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Optical Coherence Tomography (OCT) of the Retina
- What is being tested?
- OCT imaging
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Mar 2018to 13 Dec 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- patients scheduled to receive standard OCT testing as part of their clinical visit
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina Kittner Eye Center
Chapel Hill, North Carolina, 27517
About this study
Official title: Low Cost Optical Coherence Tomography for Point of Care
The purpose of this study is to compare the performance of a prototype optical coherence tomography (OCT) machine with currently available high resolution OCT machines.
- Being tested
- OCT imaging
- Medical subject headings
- Ornithine Carbamoyltransferase Deficiency Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OCT imagingDevice
imaging of retina using OCT device
| Study group | Role | What they receive |
|---|---|---|
| OCT imaging | Experimental | OCT device images retina Receives: Device: OCT imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Acceptable OCT Image Quality
measured by: ability to see clearly defined and recognizable structures of the retina with the low cost OCT device
Measured: day 1
Secondary outcomes (2)
Central Macular Thickness
compare measurements of central macular thickness obtained with low cost OCT system and Heidelberg Spectralis OCT system
Measured: day 1
Total Macular Volume
compare total macular volume measurements obtained with low cost OCT system and Heidelberg Spectralis OCT system
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2017
- Study start28 Mar 2018
- Primary completion13 Dec 2018
- Study completion13 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Optical Coherence Tomography (OCT) of the RetinaStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- University of North Carolina, Chapel Hill, Wallace H. Coulter Foundation
- Responsible party
- Sponsor
- Investigators
- Adam Wax, Ph.D., Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03323307
- Sponsor's protocol ID
- Pro00087122
- Status last verified
- Nov 2019
- First submitted
- 24 Oct 2017
- Last updated
- 5 Dec 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Cost Optical Coherence Tomography for Point of Care
- ClinicalTrials.gov ID
- NCT03323307
- Acronym / sponsor ID
- Pro00087122
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- University of North Carolina, Chapel Hill, Wallace H. Coulter Foundation
- Study start
- 28 Mar 2018 (actual)
- Primary completion
- 13 Dec 2018 (actual)
- Study completion
- 13 Dec 2018 (actual)
- First posted
- 27 Oct 2017 (actual)
- Results
- Posted 5 Dec 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare the performance of a prototype optical coherence tomography (OCT) machine with currently available high resolution OCT machines.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OCT imaging | Experimental | Device: OCT imagingOCT device images retina |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients scheduled to receive standard OCT testing as part of their clinical visit
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| OCT imagingimaging of retina using OCT device | Device | OCT imaging |
Primary outcome
Number of Participants With Acceptable OCT Image Quality
Time frame: day 1
measured by: ability to see clearly defined and recognizable structures of the retina with the low cost OCT device
2 secondary outcomes
Central Macular Thickness
Time frame: day 1
Total Macular Volume
Time frame: day 1
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Adam Wax, Ph.D. principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OCT imaging in people with Optical Coherence Tomography (OCT) of the Retina, 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 1 inclusion and 1 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 5 Dec 2019. 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?
Yes. Results are posted in the registry (first posted 5 Dec 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Acceptable OCT Image Quality (time frame: day 1). 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 5 Dec 2019.