ChoroidNCT02448355
Ocular Effects of Carotid Endarterectomy
A study testing OCT swept source DRI-Atlantis, Topcon in people with Choroid and Carotid Stenosis, run by Shaare Zedek Medical Center.
Trial summary
All patients undergoing carotid endarterectomy in Shaare Zedek Medical Hospital, during about 1 year, will be offered to participate. Retinal and choroidal structural changes will be assessed using swept-source OCT technology Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Choroid, Carotid Stenosis, Carotid Endarterectomy
- What is being tested?
- OCT swept source DRI-Atlantis, Topcon
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Mar 2016to Dec 2017
- 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 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Carotid stenosis requiring surgical management
Who cannot join
- Ocular conditions: media opacities precluding fundus visualization, bilateral no-light perception
- Ocular surgery within 6 months prior to endarterectomy
About this study
Official title: Ocular Effects of Carotid Endarterectomy A Cohort Longitudinal Study
All patients undergoing carotid endarterectomy in Shaare Zedek Medical Hospital, during about 1 year, will be offered to participate.
Retinal and choroidal structural changes will be assessed using swept-source OCT technology
- Conditions
- Choroid, Carotid Stenosis, Carotid Endarterectomy
- Being tested
- OCT swept source DRI-Atlantis, Topcon
- Keywords
- OCT
- Medical subject headings
- Carotid Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OCT swept source DRI-Atlantis, TopconDevice
3-dimensional scanning protocol with 3 μm axial resolution and a speed of 100,000 A-scans per second. 256 B-scans to be taken on an area of 12 × 9 μm.
| Study group | Role | What they receive |
|---|---|---|
| Patient undergoing carotid endarterectomy | Experimental | All patients undergoing carotid endarterectomy in Shaare Zedek Medical Center Visual acuity measurement (Snellen) SS-OCT (DRI-Atlantis, Topcon) 3-dimensional scanning protocol with 3 μm axial resolution and a speed of 100,000 A-scans per second. 256 B-scans to be taken on an area of 12 × 9 μm.
* On pre-op visit (Monday)
* Day 1 post-surgery
* Discharge day
* Week 1 post-surgery
* Month 1 post-surgery Receives: Device: OCT swept source DRI-Atlantis, Topcon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in choroidal thickness
Change in choroidal thickness (microns) on OCT pictures
Measured: one year
Secondary outcomes (2)
Visual acuity
Visual acuity as assessed by Snellen chart
Measured: One year
Retinal changes
Analysis of OCT pictures
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 2015 (estimated)
- Study startMar 2016
- Primary completionMar 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ChoroidStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shaare Zedek Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, joel hanhart, Shaare Zedek Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02448355
- Sponsor's protocol ID
- hanhart1
- Status last verified
- Nov 2015
- First submitted
- 28 Nov 2014
- Last updated
- 25 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ocular Effects of Carotid Endarterectomy A Cohort Longitudinal Study
- ClinicalTrials.gov ID
- NCT02448355
- Acronym / sponsor ID
- hanhart1
- Conditions
- Choroid, Carotid Stenosis, Carotid Endarterectomy
- Keywords
- OCT
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Shaare Zedek Medical CenterUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Mar 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 19 May 2015 (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.
All patients undergoing carotid endarterectomy in Shaare Zedek Medical Hospital, during about 1 year, will be offered to participate.
Retinal and choroidal structural changes will be assessed using swept-source OCT technology
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient undergoing carotid endarterectomy | Experimental | Device: OCT swept source DRI-Atlantis, TopconAll patients undergoing carotid endarterectomy in Shaare Zedek Medical Center Visual acuity measurement (Snellen) SS-OCT (DRI-Atlantis, Topcon) 3-dimensional scanning protocol with 3 μm axial resolution and a speed of 100,000 A-scans per second. 256 B-scans to be taken on an area of 12 × 9 μm. * On pre-op visit (Monday) * Day 1 post-surgery * Discharge day * Week 1 post-surgery * Month 1 post-surgery |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Carotid stenosis requiring surgical management
Key exclusion criteria (2 listed)
- Ocular conditions: media opacities precluding fundus visualization, bilateral no-light perception
- Ocular surgery within 6 months prior to endarterectomy
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 swept source DRI-Atlantis, Topcon3-dimensional scanning protocol with 3 μm axial resolution and a speed of 100,000 A-scans per second. 256 B-scans to be taken on an area of 12 × 9 μm. | Device | Patient undergoing carotid endarterectomy |
Primary outcome
Change in choroidal thickness
Time frame: one year
Change in choroidal thickness (microns) on OCT pictures
2 secondary outcomes
Visual acuity
Time frame: One year
Retinal changes
Time frame: One year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing OCT swept source DRI-Atlantis, Topcon in people with Choroid and Carotid Stenosis, run by Shaare Zedek Medical Center.
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 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: status not confirmed, as of the sponsor's last update on 25 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Change in choroidal thickness (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 25 Nov 2015.