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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04604002
Recruitment Status : Recruiting
First Posted : October 27, 2020
Last Update Posted : October 28, 2020
Sponsor:
Information provided by (Responsible Party):
Heidelberg Engineering GmbH

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

Condition or disease Intervention/treatment Phase
Retinal Vascular Normal Eyes Device: OCT Angiography Device: Color Fundus Photography Device: Optical Coherence Tomography Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Evaluation of Additional Heidelberg Engineering SPECTRALIS With OCT Angiography Module (OCTA Module) Scan Types
Actual Study Start Date : October 15, 2020
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : April 2021

Arm Intervention/treatment
Experimental: 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:
  • Optical Coherence Tomography Angiography
  • OCTA

Device: Color Fundus Photography
Non-contact white light photography
Other Name: CFP

Device: Optical Coherence Tomography
A non-contact test that uses light waves to take cross-sectional pictures of the retina
Other Name: OCT

Experimental: 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:
  • Optical Coherence Tomography Angiography
  • OCTA

Device: Color Fundus Photography
Non-contact white light photography
Other Name: CFP

Device: Optical Coherence Tomography
A non-contact test that uses light waves to take cross-sectional pictures of the retina
Other Name: OCT




Primary Outcome Measures :
  1. Image quality score [ Time Frame: through study completion, an average of 1 day ]
    Graded 0-2 (0 = poor, 1 = average, 2 = good)

  2. Visibility of OCTA key anatomical vascular structures quality score [ Time Frame: 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

  3. Identification of vascular abnormalities on OCTA [ Time Frame: through study completion, an average of 1 day ]
    Graded Yes, No, or Unable to Grade based on pre-specified abnormalities

  4. Adverse Events [ Time Frame: through study completion, an average of 1 day ]
    All AEs



Information from the National Library of Medicine

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Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04604002


Contacts
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Contact: Heather Oakes 508-570-8553 heather.oakes@heidelbergengineering.com

Locations
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United States, Georgia
Southeast Retina Center Recruiting
Augusta, Georgia, United States, 30909
Contact: Jennifer Anne Hurst    706-650-0061    jenniferanne@southeastretina.com   
Contact: Siobhan Ortiz    706-650-0061    siobhan@southeastretina.com   
Sponsors and Collaborators
Heidelberg Engineering GmbH
Investigators
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Principal Investigator: Dennis Marcus, MD Southeast Retina Center
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Responsible Party: Heidelberg Engineering GmbH
ClinicalTrials.gov Identifier: NCT04604002    
Other Study ID Numbers: S-2020-5
First Posted: October 27, 2020    Key Record Dates
Last Update Posted: October 28, 2020
Last Verified: October 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No