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

Retinal Vascular Clinical Trial

— OCTA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04604002
• Other study ID #: S-2020-5
• Status: Completed
• Start date: October 15, 2020
• Est. completion date: January 4, 2022

Study information

• Verified date: February 2024
• Source: Heidelberg Engineering GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: January 4, 2022
• Est. primary completion date: January 4, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 22 Years and older

Eligibility

Inclusion Criteria:

• All Populations:

1. Able and willing to undergo the test procedures, sign informed consent, and follow instructions.

2. Age = 22

• Normal Population:

3. Subjects without uncontrolled systemic conditions, as determined by the Investigator 4. Subjects without ocular disease, as determined by the Investigator 5. Corrected visual acuity = 20/40 6. No reported history of ocular surgical intervention (except for refractive or cataract surgery)

• Pathology Population:

3. Subjects with vascular abnormalities such as retinal ischemia, microaneurysms, choroidal neovascularization, retinal neovascularization in at least one eye

Exclusion Criteria:

• All Populations:

1. Subjects unable to read or write

2. Subjects with ocular media not sufficiently clear to obtain acceptable study-related imaging

3. Subjects who cannot tolerate the imaging procedures

4. Subjects without an accompanying structural OCT and CFP image for an acceptable OCTA image

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
A non-contact test that uses light waves to take cross-sectional pictures of the retina

Locations

Country	Name	City	State
United States	Southeast Retina Center	Augusta	Georgia

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	Image quality score	Graded 0-2 (0 = poor, 1 = average, 2 = good)	through study completion, an average of 1 day
Primary	Visibility of OCTA key anatomical vascular structures quality score	Graded 0-2 (easy (2), difficult (1) or unable to be distinguished (0)) based on pre-specified abnormalities	through study completion, an average of 1 day
Primary	Identification of vascular abnormalities on OCTA	Graded Yes, No, or Unable to Grade based on pre-specified abnormalities	through study completion, an average of 1 day
Primary	Adverse Events	All AEs	through study completion, an average of 1 day