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

NCT03530449 | Terminated FDA Device

• 1 other identifier: S-2018-1
• Study Type: observational
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Retinal Vascular; Normal Eyes

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

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; Device: Color Fundus Photography; Device: Optical Coherence Tomography

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; Device: Color Fundus Photography; Device: Optical Coherence Tomography

Interventions

OCT Angiography DEVICE

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.

Also known as: OCTA

Subjects with Normal Eyes; Subjects with Retinal Vascular Pathology

Color Fundus Photography DEVICE

Non-contact white light photography

Also known as: CFP

Subjects with Normal Eyes; Subjects with Retinal Vascular Pathology

Optical Coherence Tomography DEVICE

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.

Also known as: Structural OCT, OCT

Subjects with Normal Eyes; Subjects with Retinal Vascular Pathology

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Heidelberg Engineering GmbH: lead

Study Sites (1)

State University of New York College of Optometry (SUNY)

New York, New York, 10036, United States

Location

MeSH Terms

Interventions

Tomography, Optical Coherence

Intervention Hierarchy (Ancestors)

Tomography, Optical; Optical Imaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography; Investigative Techniques

Study Officials

• Mitchell W Dul, OD

  State University of New York College of Optometry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2018
• First Posted: May 21, 2018
• Study Start: April 30, 2018
• Primary Completion: September 15, 2018
• Study Completion: September 15, 2018
• Last Updated: February 28, 2019

Record last verified: 2019-02

Locations

US (1)