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

Heidelberg Engineering

Status: Completed

Conditions: Normal Eyes; Retinal Vascular

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

Study type: Observational

Funder types: Industry

Identifiers

NCT04604002

S-2020-5

Details and patient eligibility

About

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

Full 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.

Enrollment: 86 patients

Sex: All

Ages: 22+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

86 participants in 2 patient groups

Subjects with Normal Eyes

Description:

OCT, Color Fundus Photography and OCT Angiography as per protocol in subjects without ophthalmic pathology

Treatment:

Device: Color Fundus Photography

Device: OCT Angiography

Device: Optical Coherence Tomography

Subjects with Pathology

Description:

OCT, Color Fundus Photography and OCT Angiography as per protocol in subjects with retinal vascular pathology

Treatment:

Device: Color Fundus Photography

Device: OCT Angiography

Device: Optical Coherence Tomography