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

Retinal Vascular Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03530449
• Other study ID #: S-2018-1
• Status: Terminated
• Start date: April 30, 2018
• Est. completion date: September 15, 2018

Study information

• Verified date: February 2019
• Source: Heidelberg Engineering GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 39
• Est. completion date: September 15, 2018
• Est. primary completion date: September 15, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 22 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Normal Eyes
• Retinal Vascular

Intervention

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.
• Color Fundus Photography
Non-contact white light photography
• 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.

Locations

Country	Name	City	State
United States	State University of New York College of Optometry (SUNY)	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Heidelberg Engineering GmbH

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	OCTA image quality	Image quality grading results of study selected images	day 1
Primary	Visualization of key anatomical vascular structures on OCTA	Grading of visibility of key anatomical vascular structures of study selected images	day 1