NCT04604002

Evaluation of Additional Heidelberg Engineering SPECTRALIS With OCT Angiography Module (OCTA Module) Scan Types

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 86 (actual)
• Sponsor: Heidelberg Engineering GmbH · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Accepted

Summary

Assessment of image quality and clinical relevance of OCT Angiography at different speed/ART combinations

Detailed description

The objectives of this study are: 1.) Compare the image quality between the predicate scan types and the corresponding investigational scan types. 2\. Compare the visibility of key anatomical vascular structures between the predicate scan types and the corresponding investigational scan types. 3\. Assess the agreement in identification of vascular abnormalities between the predicate scan types and the corresponding investigational scan types, where agreement is assessed by the vascular abnormalities identified from the predicate scan types.

Conditions

• Retinal Vascular
• Normal Eyes

Interventions

Type	Name	Description
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.
DEVICE	Color Fundus Photography	Non-contact white light photography
DEVICE	Optical Coherence Tomography	A non-contact test that uses light waves to take cross-sectional pictures of the retina

Timeline

• Start date: 2020-10-15
• Primary completion: 2022-01-04
• Completion: 2022-01-04
• First posted: 2020-10-27
• Last updated: 2024-02-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study