Evaluation of Heidelberg Engineering SPECTRALIS With OCT Angiography Module

September 9, 2025 updated by: Heidelberg Engineering GmbH
Assessment of image quality and clinical relevance of OCT Angiography via comparison to FA/ICGA.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The objectives of this study are:

  1. To compare the OCTA image quality between the SPECTRALIS and the predicate.
  2. To compare the agreement of clinical findings on SPECTRALIS OCTA to the predicate.

Study Type

Observational

Enrollment (Actual)

88

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • Retina Consultants of Houston

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

22 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Subjects with Normal Eyes:

  • Subjects presenting at the site without uncontrolled systemic conditions, or ocular disease, as determined by the Investigator
  • Corrected visual acuity ≥ 20/40 in each eye
  • No history of ocular surgical intervention (except for refractive or cataract surgery) in either eye

Subjects with Pathology:

  • Subjects with retinal conditions in at least one eye.
  • Subjects included can have a range of retinal vascular pathologies affecting different anatomic depths through the retina and choroid. Retinal conditions including but not limited to diabetic retinopathy, wet age-related macular degeneration (AMD), and branch or central retinal vein occlusion that give rise to features such as retinal ischemia, microaneurysms, choroidal neovascularization and retinal neovascularization will be included.

Description

Inclusion Criteria:

All subjects:

  • Able and willing to undergo the test procedures, sign informed consent, and follow instructions.
  • Age ≥ 22

Subjects with Normal Eyes:

  • Subjects presenting at the site without uncontrolled systemic conditions, or ocular disease, as determined by the Investigator
  • Corrected visual acuity ≥ 20/40 in each eye
  • No history of ocular surgical intervention (except for refractive or cataract surgery) in either eye

Subjects with Pathology:

  • Subjects with retinal conditions in at least one eye.
  • Subjects included can have a range of retinal vascular pathologies affecting different anatomic depths through the retina and choroid. Retinal conditions including but not limited to diabetic retinopathy, wet age-related macular degeneration (AMD), and branch or central retinal vein occlusion that give rise to features such as retinal ischemia, microaneurysms, choroidal neovascularization and retinal neovascularization will be included.

Exclusion Criteria:

  • 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 with known allergies to fluorescein dye, Indocyanine Green (ICG), shellfish, drugs for pupillary dilation
  • Subjects with contraindication to pupillary dilation in study eye

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Subjects with Normal Eyes
OCT Angiography, Color Fundus Photography, and Fluorescein 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
Device: Color Fundus Photography
Non-contact white light photography.
Other Names:
  • CFP
Device: Fluorescein Angiography
An imaging procedure where dye is injected into a vein and images are taken of the back of the eye to visualize the perfusion of retinal vessels in two dimensional images.
Other Names:
  • FA
Subjects with Pathology
OCT Angiography, Color Fundus Photography, Fluorescein Angiography, and when clinically indicated, Indocyaine Green 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
Device: Color Fundus Photography
Non-contact white light photography.
Other Names:
  • CFP
Device: Fluorescein Angiography
An imaging procedure where dye is injected into a vein and images are taken of the back of the eye to visualize the perfusion of retinal vessels in two dimensional images.
Other Names:
  • FA
Device: Indocyaine Green Angiography
An imaging procedure where dye is injected into a vein and images are taken of the back of the eye to visualize the perfusion of choroidal vessels in two dimensional images.
Other Names:
  • ICGA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
OCTA image quality
Time Frame: day 1
Image quality grading results of study selected images
day 1
Clinically relevant findings on OCTA
Time Frame: day 1
Clinically relevant grading results of study selected images
day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Heidelberg Engineering GmbH

Investigators

  • Principal Investigator: David Brown, MD, Retina Consultants Houston

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 23, 2017

Primary Completion (Actual)

January 12, 2018

Study Completion (Actual)

January 12, 2018

Study Registration Dates

First Submitted

September 4, 2017

First Submitted That Met QC Criteria

September 11, 2017

First Posted (Actual)

September 12, 2017

Study Record Updates

Last Update Posted (Estimated)

September 15, 2025

Last Update Submitted That Met QC Criteria

September 9, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S-2017-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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