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

Heidelberg Engineering

Status: Terminated

Conditions: Normal Eyes; Retinal Vascular

Treatments: Device: Optical Coherence Tomography; Device: OCT Angiography; Device: Color Fundus Photography

Study type: Observational

Funder types: Industry

Identifiers

NCT03530449

S-2018-1

Details and patient eligibility

About

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

Full 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

Enrollment: 39 patients

Sex: All

Ages: 22+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

39 participants in 2 patient groups

Subjects with Normal Eyes

Description:

Color Fundus Photography, Optical Coherence Tomography, and OCT Angiography scans as per protocol in subjects without ophthalmic pathology

Treatment:

Device: Color Fundus Photography

Device: OCT Angiography

Device: Optical Coherence Tomography

Subjects with Retinal Vascular Pathology

Description:

Color Fundus Photography, Optical Coherence Tomography, and OCT Angiography scans as per protocol in subjects with retinal vascular ophthalmic pathology

Treatment:

Device: Color Fundus Photography

Device: OCT Angiography

Device: Optical Coherence Tomography