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

Completed

• Conditions: Retinal Vascular; Normal Eyes
• Interventions: Device: OCT Angiography; Device: Color Fundus Photography; Device: Optical Coherence Tomography

• Registration Number: NCT04604002
• Lead Sponsor: Heidelberg Engineering GmbH

Brief 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.

Study Timeline

• Study Start: 2020-10-15
• Study First Submitted: 2020-10-20
• Study First Submitted QC: 2020-10-26
• Study First Posted: 2020-10-27
• Primary Completion: 2022-01-04
• Study Completion: 2022-01-04
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-26
• Last Update Posted: 2024-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 86

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Subjects with Normal Eyes	Optical Coherence Tomography	OCT, Color Fundus Photography and OCT Angiography as per protocol in subjects without ophthalmic pathology
Subjects with Normal Eyes	Color Fundus Photography	OCT, Color Fundus Photography and OCT Angiography as per protocol in subjects without ophthalmic pathology
Subjects with Pathology	OCT Angiography	OCT, Color Fundus Photography and OCT Angiography as per protocol in subjects with retinal vascular pathology
Subjects with Normal Eyes	OCT Angiography	OCT, Color Fundus Photography and OCT Angiography as per protocol in subjects without ophthalmic pathology
Subjects with Pathology	Optical Coherence Tomography	OCT, Color Fundus Photography and OCT Angiography as per protocol in subjects with retinal vascular pathology
Subjects with Pathology	Color Fundus Photography	OCT, Color Fundus Photography and OCT Angiography as per protocol in subjects with retinal vascular pathology

Primary Outcome Measures

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

Trial Locations

Locations (1)

Southeast Retina Center; 🇺🇸 Augusta, Georgia, United States