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OpenTrials
Completed

NCT Number: NCT04604002

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

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

Completed

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Key information

Age range

22 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Southeast Retina Center

Augusta, Georgia, 30909, United States

About this study

The objectives of this study are:

1.) Compare the image quality between the predicate scan types and the corresponding investigational scan types.

  • Compare the visibility of key anatomical vascular structures between the predicate scan types and the corresponding investigational scan types.
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All Populations:
  • Able and willing to undergo the test procedures, sign informed consent, and follow instructions.
  • Age ≥ 22
  • Normal Population:
  • 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:
  • Subjects with vascular abnormalities such as retinal ischemia, microaneurysms, choroidal neovascularization, retinal neovascularization in at least one eye

Exclusion criteria

  • All Populations:
  • Subjects unable to read or write
  • Subjects with ocular media not sufficiently clear to obtain acceptable study-related imaging
  • Subjects who cannot tolerate the imaging procedures
  • Subjects without an accompanying structural OCT and CFP image for an acceptable OCTA image

Treatment and study plan

OCT Angiography

Device

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

Color Fundus Photography

Device

Non-contact white light photography

Other names: CFP

optical coherence tomography

Device

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

Other names: OCT

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Heidelberg Engineering GmbH

Industry

Registry information

Acronym: OCTA

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Oct 27, 2020
Registry last updated
Feb 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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