Evaluation of the Repeatability and Reproducibility of OCTA Image Quality With the Heidelberg Engineering SPECTRALIS With OCT Angiography Module

Repeatability and Reproducibility of OCTA Image Quality with the Heidelberg Engineering SPECTRALIS

Study Overview

• Status: Terminated
• Conditions: Normal Eyes; Retinal Vascular
• Intervention / Treatment: Device: OCT Angiography; Device: Color Fundus Photography; Device: Optical Coherence Tomography

Detailed Description

The objectives of this study are to:

1. Assess the repeatability and reproducibility of the SPECTRALIS with OCTA Module image quality
2. Assess the repeatability and reproducibility of visibility of key anatomical vascular structures in the SPECTRALIS with OCTA Module

• Study Type: Observational
• Enrollment (Actual): 39

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10036
      • State University of New York College of Optometry (SUNY)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Pathology Population:

Subjects included should have a range of retinal vascular pathologies likely to appear in OCTA imaging, affecting different anatomic depths through the retina and choroid. Retinal vascular conditions including but not limited to diabetic retinopathy, wet age-related macular degeneration (AMD), and branch or central retinal vein occlusion that give rise to features such as retinal ischemia, microaneurysms, choroidal neovascularization and retinal neovascularization will be included.

Normal Population:

In order to be included in the Normal population, subjects will have to meet all inclusion/exclusion criteria for both eyes. Subjects with a history of ocular surgical interventions will be excluded except for those with refractive and/or cataract surgery.

Description

Inclusion Criteria:

• All subjects: Able and willing to undergo the test procedures, sign informed consent, and follow instructions.
• Age ≥ 22

Subjects with Normal Eyes:

• Corrected visual acuity ≥ 20/40 in each eye

Subjects with Pathology:

• Subjects with vascular retinal conditions in at least one eye
• Subjects included should have a range of retinal vascular pathologies likely to appear in OCTA imaging, affecting different anatomic depths through the retina and choroid. Retinal conditions including but not limited to diabetic retinopathy, wet age-related macular degeneration (AMD), and branch or central retinal vein occlusion that give rise to features such as retinal ischemia, microaneurysms, choroidal neovascularization and retinal neovascularization will be included.

Exclusion Criteria:

• All Subjects:
• Subjects unable to read or write
• Subjects with ocular media not sufficiently clear to obtain acceptable study- related imaging
• Subjects who cannot tolerate the imaging procedures
• Subjects with contraindication to pupillary dilation in the study eye
• Subjects with Normal Eyes:
• Subjects with uncontrolled systemic conditions, or ocular disease, as determined by the Investigator, during the eye exam and CFP
• History of ocular surgical intervention (except for refractive or cataract surgery) in either eye

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Subjects with Normal Eyes; Color Fundus Photography, Optical Coherence Tomography, and OCT Angiography scans as per protocol in subjects without ophthalmic pathology	Device: OCT Angiography; OCT Angiography offers clinicians a non-invasive three-dimensional visualization of vasculature in the retina and choroid. The visualization of perfused vasculature in a three-dimensional layout, offers clinicians an aid in the identification of retinal and choroidal pathologies such as retinal ischemia, microaneurysms, retinal neovascularization and choroidal neovascular membranes.; Other Names: OCTA; Device: Color Fundus Photography; Non-contact white light photography; Other Names: CFP; Device: Optical Coherence Tomography; Two and Three dimensional cross sectional imaging of the back of the eye to look at vascular structures and is an aid in the detection and management of various ocular diseases.; Other Names: OCT; Structural OCT
Subjects with Retinal Vascular Pathology; Color Fundus Photography, Optical Coherence Tomography, and OCT Angiography scans as per protocol in subjects with retinal vascular ophthalmic pathology	Device: OCT Angiography; OCT Angiography offers clinicians a non-invasive three-dimensional visualization of vasculature in the retina and choroid. The visualization of perfused vasculature in a three-dimensional layout, offers clinicians an aid in the identification of retinal and choroidal pathologies such as retinal ischemia, microaneurysms, retinal neovascularization and choroidal neovascular membranes.; Other Names: OCTA; Device: Color Fundus Photography; Non-contact white light photography; Other Names: CFP; Device: Optical Coherence Tomography; Two and Three dimensional cross sectional imaging of the back of the eye to look at vascular structures and is an aid in the detection and management of various ocular diseases.; Other Names: OCT; Structural OCT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
OCTA image quality	Image quality grading results of study selected images	day 1
Visualization of key anatomical vascular structures on OCTA	Grading of visibility of key anatomical vascular structures of study selected images	day 1

Collaborators and Investigators

• Sponsor: Heidelberg Engineering GmbH
• Investigators: Principal Investigator: Mitchell W Dul, OD, State University of New York College of Optometry

Study record dates

Study Major Dates

• Study Start (Actual): April 30, 2018
• Primary Completion (Actual): September 15, 2018
• Study Completion (Actual): September 15, 2018

Study Registration Dates

• First Submitted: May 8, 2018
• First Submitted That Met QC Criteria: May 8, 2018
• First Posted (Actual): May 21, 2018

Study Record Updates

• Last Update Posted (Actual): February 28, 2019
• Last Update Submitted That Met QC Criteria: February 26, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: S-2018-1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No