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

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

Study Overview

• Status: Completed
• Conditions: Normal Eyes; Retinal Vascular
• Intervention / Treatment: Device: OCT Angiography; Device: Color Fundus Photography; Device: Optical Coherence Tomography

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.

• Study Type: Observational
• Enrollment (Actual): 86
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Augusta, Georgia, United States, 30909
      • Southeast Retina Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Adults with Healthy Eyes and Adults with Eyes with retinal vascular pathology

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Subjects with Normal Eyes; OCT, Color Fundus Photography and OCT Angiography as per protocol in subjects without ophthalmic pathology	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.; Other Names: OCTA; Optical Coherence Tomography Angiography; Device: Color Fundus Photography; Non-contact white light photography; Other Names: CFP; Device: Optical Coherence Tomography; A non-contact test that uses light waves to take cross-sectional pictures of the retina; Other Names: OCT
Subjects with Pathology; OCT, Color Fundus Photography and OCT Angiography as per protocol in subjects with retinal vascular pathology	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.; Other Names: OCTA; Optical Coherence Tomography Angiography; Device: Color Fundus Photography; Non-contact white light photography; Other Names: CFP; Device: Optical Coherence Tomography; A non-contact test that uses light waves to take cross-sectional pictures of the retina; Other Names: OCT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Image quality score	Graded 0-2 (0 = poor, 1 = average, 2 = good)	through study completion, an average of 1 day
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
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
Adverse Events	All AEs	through study completion, an average of 1 day

Collaborators and Investigators

• Sponsor: Heidelberg Engineering GmbH
• Investigators: Principal Investigator: Dennis Marcus, MD, Southeast Retina Center

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2020
• Primary Completion (Actual): January 4, 2022
• Study Completion (Actual): January 4, 2022

Study Registration Dates

• First Submitted: October 20, 2020
• First Submitted That Met QC Criteria: October 26, 2020
• First Posted (Actual): October 27, 2020

Study Record Updates

• Last Update Posted (Actual): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 26, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: S-2020-5

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No