Swept Source Enhanced Depth Imaging Optical Coherence Tomography

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: Unknown
• Conditions: Retina, Choroid, Sclera
• Intervention / Treatment: Device: DRI-1 Swept source OCT, Atlantis, Topcon

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: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

9

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Difference in chorio-retinal depth and morphology between healthy and diseased subjects	2 years

Collaborators and Investigators

• Sponsor: Shaare Zedek Medical Center

Study record dates

Study Major Dates

• Study Start: May 1, 2016
• Primary Completion (Anticipated): July 1, 2017
• Study Completion (Anticipated): August 1, 2019

Study Registration Dates

• First Submitted: March 1, 2015
• First Submitted That Met QC Criteria: May 10, 2015
• First Posted (Estimate): May 13, 2015

Study Record Updates

• Last Update Posted (Estimate): November 24, 2015
• Last Update Submitted That Met QC Criteria: November 23, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: 185/14