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

Terminated

• Conditions: Normal Eyes; Retinal Vascular

• Registration Number: NCT03530449
• Lead Sponsor: Heidelberg Engineering GmbH

Brief Summary

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

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 Timeline

• Study Start: 2018-04-30
• Study First Submitted: 2018-05-08
• Study First Submitted QC: 2018-05-08
• Study First Posted: 2018-05-21
• Primary Completion: 2018-09-15
• Study Completion: 2018-09-15
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-26
• Last Update Posted: 2019-02-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 39

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
OCTA image quality	day 1	Image quality grading results of study selected images
Visualization of key anatomical vascular structures on OCTA	day 1	Grading of visibility of key anatomical vascular structures of study selected images

Trial Locations

Locations (1)

State University of New York College of Optometry (SUNY); 🇺🇸 New York, New York, United States