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Swept Source Enhanced Depth Imaging Optical Coherence Tomography

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ClinicalTrials.gov Identifier: NCT02443129
Recruitment Status : Not yet recruiting
First Posted : May 13, 2015
Last Update Posted : November 24, 2015
Sponsor:
Information provided by (Responsible Party):
Shaare Zedek Medical Center

Brief 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.

Condition or disease Intervention/treatment Phase
Retina, Choroid, Sclera Device: DRI-1 Swept source OCT, Atlantis, Topcon Not Applicable

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).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Basic Science
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
Study Start Date : May 2016
Estimated Primary Completion Date : July 2017
Estimated Study Completion Date : August 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Difference in chorio-retinal depth and morphology between healthy and diseased subjects [ Time Frame: 2 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Ability to sit for OCT

Exclusion Criteria:

  • Media opacities precluding fundus view

Layout table for additonal information
Responsible Party: Shaare Zedek Medical Center
ClinicalTrials.gov Identifier: NCT02443129     History of Changes
Other Study ID Numbers: 185/14
First Posted: May 13, 2015    Key Record Dates
Last Update Posted: November 24, 2015
Last Verified: November 2015