Swept Source Enhanced Depth Imaging Optical Coherence Tomography

November 23, 2015 updated by: Shaare Zedek Medical Center

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Ability to sit for OCT

Exclusion Criteria:

  • Media opacities precluding fundus view

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: control group

18-99 year old male + female

Intervention:

DRI-1 Swept source OCT, Atlantis, Topcon
Device: DRI-1 Swept source OCT, Atlantis, Topcon
Fundus imaging
Experimental: mydramide only

Patients in the clinics undergoing pupil dilation

Intervention:

Tropicamide instillation to both eyes DRI-1 Swept source OCT, Atlantis, Topcon
Device: DRI-1 Swept source OCT, Atlantis, Topcon
Fundus imaging
Experimental: mydramide and ephrine 10%

Patients in the clinics undergoing pupil dilation

Intervention:

Tropicamide and ephrine 10% instillation to both eyes DRI-1 Swept source OCT, Atlantis, Topcon
Device: DRI-1 Swept source OCT, Atlantis, Topcon
Fundus imaging
Experimental: All patients presenting with RD

Patients with retinal detachment

Intervention:

RD surgery DRI-1 Swept source OCT, Atlantis, Topcon
Device: DRI-1 Swept source OCT, Atlantis, Topcon
Fundus imaging
Experimental: Impact of previous grid treatment

Patients after grid laser

Intervention:

DRI-1 Swept source OCT, Atlantis, Topcon
Device: DRI-1 Swept source OCT, Atlantis, Topcon
Fundus imaging
Experimental: Effect of glaucoma medications

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
Device: DRI-1 Swept source OCT, Atlantis, Topcon
Fundus imaging
Experimental: Effect of arteritic/non-arteritic AION

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
Device: DRI-1 Swept source OCT, Atlantis, Topcon
Fundus imaging
Experimental: NVAMD poorly responsive to Rx

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
Device: DRI-1 Swept source OCT, Atlantis, Topcon
Fundus imaging
Experimental: Retrospective analysis

All patients pictured with DRI-OCT

Intervention:

DRI-1 Swept source OCT, Atlantis, Topcon
Device: DRI-1 Swept source OCT, Atlantis, Topcon
Fundus imaging

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Difference in chorio-retinal depth and morphology between healthy and diseased subjects
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shaare Zedek Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2016

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2017

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 1, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 10, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 13, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 24, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 23, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 185/14

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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