Retina, Choroid, ScleraNCT02443129
Swept Source Enhanced Depth Imaging Optical Coherence Tomography
A study testing DRI-1 Swept source OCT, Atlantis, Topcon in people with Retina, Choroid, Sclera, run by Shaare Zedek Medical Center.
Trial summary
The investigators would be interested in applying the enhanced depth imaging technique to swept source optical coherence tomography, by modifying the acquisition protocol. Doing so, the investigators hope to improve the visualization of the choroid and perhaps even of the sclera. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Retina, Choroid, Sclera
- What is being tested?
- DRI-1 Swept source OCT, Atlantis, Topcon
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- May 2016to Aug 2019
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Ability to sit for OCT
Who cannot join
- Media opacities precluding fundus view
About this study
Official title: Swept Source Enhanced Depth Imaging Optical Coherence Tomography (SS-EDI-OCT) and Study of the Retina, Choroid and Sclera in Health and Disease
The investigators would be interested in applying the enhanced depth imaging technique to swept source optical coherence tomography, by modifying the acquisition protocol. Doing so, the investigators hope to improve the visualization of the choroid and perhaps even of the sclera.
Read the detailed description
A structurally and functionally normal choroidal vasculature is essential for retinal function. The status of the choroid appears to be a crucial determinant in the pathogenesis of diseases such as age-related choroidal atrophy, myopic chorioretinal atrophy, central serous chorioretinopathy, chorioretinal inflammatory diseases, and tumors.
The in vivo structure of the choroid in health and disease is incompletely visualized with traditional imaging modalities, including indocyanine green angiography and ultrasonography.
Optical coherence tomography (OCT) is an established medical imaging technique that uses light to capture micrometer-resolution, three-dimensional images from within optical scattering media. OCT is based on low-coherence interferometry. Nowadays, it is essential for managing retinal conditions.
Unfortunately, standard spectral domain optic coherence tomography (SD-OCT) is of limited use in imaging choroidal morphology.
A modification to the standard technique, termed enhanced depth imaging optical coherence tomography (EDI-OCT), is able to image the choroid with better clarity using commercial SD-OCTs.
With the advent of enhanced depth imaging optical coherence tomography (EDI-OCT), detailed visualisation of the choroid in vivo has been made possible possible. Measurements of choroidal thickness (CT) have also enabled new directions in research to study normal and pathological processes within the choroid.
However, EDI-OCT has its own limitations: the outer choroidal border cannot always be visualized and choroidal details sometime lack clarity.
A new generation of OCTs has been made available, based on swept-source technology.
Swept source OCT (SS-OCT) has been shown to be more precise than spectral domain EDI-OCT in measuring choroidal thickness.
Our department is now using two OCTs, one is a SD- OCT (Canon HS-100), the other one a SS- OCT (Topcon DRI Atlantis).
The investigators would be interested in applying the EDI technique to SS- OCT, by modifying the acquisition protocol. Doing so, the investigators hope to improve the visualization of the choroid and perhaps even of the sclera.
This modification is based on the technique described by Spaide for SD-OCT.
From the patient's perspective, it only involves spending more time fixing the green stimulus (about 4 minutes instead of 2, in order to follow the swept-source EDI protocol in addition to standard swept source).
- Conditions
- Retina, Choroid, Sclera
- Being tested
- DRI-1 Swept source OCT, Atlantis, Topcon
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DRI-1 Swept source OCT, Atlantis, TopconDevice
Fundus imaging
| Study group | Role | What they receive |
|---|---|---|
| control group | Experimental | 18-99 year old male + female
Intervention:
DRI-1 Swept source OCT, Atlantis, Topcon Receives: Device: DRI-1 Swept source OCT, Atlantis, Topcon |
| mydramide only | Experimental | Patients in the clinics undergoing pupil dilation
Intervention:
Tropicamide instillation to both eyes DRI-1 Swept source OCT, Atlantis, Topcon Receives: Device: DRI-1 Swept source OCT, Atlantis, Topcon |
| mydramide and ephrine 10% | Experimental | Patients in the clinics undergoing pupil dilation
Intervention:
Tropicamide and ephrine 10% instillation to both eyes DRI-1 Swept source OCT, Atlantis, Topcon Receives: Device: DRI-1 Swept source OCT, Atlantis, Topcon |
| All patients presenting with RD | Experimental | Patients with retinal detachment
Intervention:
RD surgery DRI-1 Swept source OCT, Atlantis, Topcon Receives: Device: DRI-1 Swept source OCT, Atlantis, Topcon |
| Impact of previous grid treatment | Experimental | Patients after grid laser
Intervention:
DRI-1 Swept source OCT, Atlantis, Topcon Receives: Device: DRI-1 Swept source OCT, Atlantis, Topcon |
| Effect of glaucoma medications | Experimental | Patients requiring new intraocular presssur (IOP)-lowering treatment Patients with long-term IOP-lowering treatment
Intervention:
If needed, start of new IOP-lowering treatment DRI-1 Swept source OCT, Atlantis, Topcon Receives: Device: DRI-1 Swept source OCT, Atlantis, Topcon |
| Effect of arteritic/non-arteritic AION | Experimental | About 180 living patients diagnosed at ShaareZedek with anterior ischemic optic neuropathy (AION).
Longitudinal arm with newly diagnosed patients for 2 years follow-up
Intervention:
DRI-1 Swept source OCT, Atlantis, Topcon Receives: Device: DRI-1 Swept source OCT, Atlantis, Topcon |
| NVAMD poorly responsive to Rx | Experimental | Patients with neovascular age-related macular degeneration and epiretinal membreane/vitreomacular traction who do not respond to first course of Avastin
Intervention:
DRI-1 Swept source OCT, Atlantis, Topcon Receives: Device: DRI-1 Swept source OCT, Atlantis, Topcon |
| Retrospective analysis | Experimental | All patients pictured with DRI-OCT
Intervention:
DRI-1 Swept source OCT, Atlantis, Topcon Receives: Device: DRI-1 Swept source OCT, Atlantis, Topcon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in chorio-retinal depth and morphology between healthy and diseased subjects
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2015 (estimated)
- Study startMay 2016
- Primary completionJul 2017 (estimated)
- Study completionAug 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retina, Choroid, ScleraStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shaare Zedek Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02443129
- Sponsor's protocol ID
- 185/14
- Status last verified
- Nov 2015
- First submitted
- 1 Mar 2015
- Last updated
- 24 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Swept Source Enhanced Depth Imaging Optical Coherence Tomography (SS-EDI-OCT) and Study of the Retina, Choroid and Sclera in Health and Disease
- ClinicalTrials.gov ID
- NCT02443129
- Acronym / sponsor ID
- 185/14
- Conditions
- Retina, Choroid, Sclera
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Shaare Zedek Medical CenterUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- Jul 2017 (estimated)
- Study completion
- Aug 2019 (estimated)
- First posted
- 13 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.
The investigators would be interested in applying the enhanced depth imaging technique to swept source optical coherence tomography, by modifying the acquisition protocol. Doing so, the investigators hope to improve the visualization of the choroid and perhaps even of the sclera.
Detailed description
A structurally and functionally normal choroidal vasculature is essential for retinal function. The status of the choroid appears to be a crucial determinant in the pathogenesis of diseases such as age-related choroidal atrophy, myopic chorioretinal atrophy, central serous chorioretinopathy, chorioretinal inflammatory diseases, and tumors.
The in vivo structure of the choroid in health and disease is incompletely visualized with traditional imaging modalities, including indocyanine green angiography and ultrasonography.
Optical coherence tomography (OCT) is an established medical imaging technique that uses light to capture micrometer-resolution, three-dimensional images from within optical scattering media. OCT is based on low-coherence interferometry. Nowadays, it is essential for managing retinal conditions.
Unfortunately, standard spectral domain optic coherence tomography (SD-OCT) is of limited use in imaging choroidal morphology.
A modification to the standard technique, termed enhanced depth imaging optical coherence tomography (EDI-OCT), is able to image the choroid with better clarity using commercial SD-OCTs.
With the advent of enhanced depth imaging optical coherence tomography (EDI-OCT), detailed visualisation of the choroid in vivo has been made possible possible. Measurements of choroidal thickness (CT) have also enabled new directions in research to study normal and pathological processes within the choroid.
However, EDI-OCT has its own limitations: the outer choroidal border cannot always be visualized and choroidal details sometime lack clarity.
A new generation of OCTs has been made available, based on swept-source technology.
Swept source OCT (SS-OCT) has been shown to be more precise than spectral domain EDI-OCT in measuring choroidal thickness.
Our department is now using two OCTs, one is a SD- OCT (Canon HS-100), the other one a SS- OCT (Topcon DRI Atlantis).
The investigators would be interested in applying the EDI technique to SS- OCT, by modifying the acquisition protocol. Doing so, the investigators hope to improve the visualization of the choroid and perhaps even of the sclera.
This modification is based on the technique described by Spaide for SD-OCT.
From the patient's perspective, it only involves spending more time fixing the green stimulus (about 4 minutes instead of 2, in order to follow the swept-source EDI protocol in addition to standard swept source).
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| control group | Experimental | Device: DRI-1 Swept source OCT, Atlantis, Topcon18-99 year old male + female Intervention: DRI-1 Swept source OCT, Atlantis, Topcon |
| mydramide only | Experimental | Device: DRI-1 Swept source OCT, Atlantis, TopconPatients in the clinics undergoing pupil dilation Intervention: Tropicamide instillation to both eyes DRI-1 Swept source OCT, Atlantis, Topcon |
| mydramide and ephrine 10% | Experimental | Device: DRI-1 Swept source OCT, Atlantis, TopconPatients in the clinics undergoing pupil dilation Intervention: Tropicamide and ephrine 10% instillation to both eyes DRI-1 Swept source OCT, Atlantis, Topcon |
| All patients presenting with RD | Experimental | Device: DRI-1 Swept source OCT, Atlantis, TopconPatients with retinal detachment Intervention: RD surgery DRI-1 Swept source OCT, Atlantis, Topcon |
| Impact of previous grid treatment | Experimental | Device: DRI-1 Swept source OCT, Atlantis, TopconPatients after grid laser Intervention: DRI-1 Swept source OCT, Atlantis, Topcon |
| Effect of glaucoma medications | Experimental | Device: DRI-1 Swept source OCT, Atlantis, TopconPatients requiring new intraocular presssur (IOP)-lowering treatment Patients with long-term IOP-lowering treatment Intervention: If needed, start of new IOP-lowering treatment DRI-1 Swept source OCT, Atlantis, Topcon |
| Effect of arteritic/non-arteritic AION | Experimental | Device: DRI-1 Swept source OCT, Atlantis, TopconAbout 180 living patients diagnosed at ShaareZedek with anterior ischemic optic neuropathy (AION). Longitudinal arm with newly diagnosed patients for 2 years follow-up Intervention: DRI-1 Swept source OCT, Atlantis, Topcon |
| NVAMD poorly responsive to Rx | Experimental | Device: DRI-1 Swept source OCT, Atlantis, TopconPatients with neovascular age-related macular degeneration and epiretinal membreane/vitreomacular traction who do not respond to first course of Avastin Intervention: DRI-1 Swept source OCT, Atlantis, Topcon |
| Retrospective analysis | Experimental | Device: DRI-1 Swept source OCT, Atlantis, TopconAll patients pictured with DRI-OCT Intervention: DRI-1 Swept source OCT, Atlantis, Topcon |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Ability to sit for OCT
Key exclusion criteria (1 listed)
- Media opacities precluding fundus view
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 |
|---|---|---|
| DRI-1 Swept source OCT, Atlantis, TopconFundus imaging | Device | All patients presenting with RD, Effect of arteritic/non-arteritic AION, Effect of glaucoma medications, Impact of previous grid treatment, NVAMD poorly responsive to Rx, Retrospective analysis, control group, mydramide and ephrine 10%, mydramide only |
Primary outcome
Difference in chorio-retinal depth and morphology between healthy and diseased subjects
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2015.
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 DRI-1 Swept source OCT, Atlantis, Topcon in people with Retina, Choroid, Sclera, 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 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: status not confirmed, as of the sponsor's last update on 24 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?
Difference in chorio-retinal depth and morphology between healthy and diseased subjects (time frame: 2 years). 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 24 Nov 2015.