ClinicalTrials.gg
CompletedNCT03279939Updated Sep 15, 2025

Evaluation of Heidelberg Engineering SPECTRALIS With OCT Angiography Module

An observational study in Retinal Vascular and Normal Eyes, sponsored by Heidelberg Engineering GmbH. Completed at 1 site in United States. Open to participants aged 22 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-15.

Sponsored by Heidelberg Engineering GmbH (part of EssilorLuxottica) · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
88
Ages
22 Years and older
Sex
All
01

Study summary

Assessment of image quality and clinical relevance of OCT Angiography via comparison to FA/ICGA.

Read the 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.
02

Conditions studied

  • Retinal Vascular
  • Normal Eyes
03

In context

Lead sponsor

Heidelberg Engineering GmbH is the lead sponsor of 22 studies on the registry; 1 is open to participants now.

First submitted before Heidelberg Engineering GmbH became part of EssilorLuxottica.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
22 Years and older
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

All subjects:

  • Able and willing to undergo the test procedures, sign , 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

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 to pupillary dilation in study eye
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
88 participants (actual)
Patient registry
No

Groups and cohorts

  • Subjects with Normal Eyes

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

    Device: OCT Angiography · Device: Color Fundus Photography · Device: Fluorescein Angiography

  • 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 · Device: Color Fundus Photography · Device: Fluorescein Angiography · Device: Indocyaine Green Angiography

Interventions

  • DeviceOCT 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.

    Also known as: OCTA

  • DeviceColor Fundus Photography

    Non-contact white light photography.

    Also known as: CFP

  • DeviceFluorescein 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.

    Also known as: FA

  • DeviceIndocyaine 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.

    Also known as: ICGA

06

What researchers measure

Primary outcomes

  1. OCTA image quality

    Image quality grading results of study selected images

    Time frame: day 1

  2. Clinically relevant findings on OCTA

    Clinically relevant grading results of study selected images

    Time frame: day 1

07

Study locations

1 site
  • Retina Consultants of Houston
    Houston, Texas 77030, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Aug 2017 to primary completion in Jan 2018, 4 months.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 4, 2017
First posted
Sep 12, 2017
StartActual
Aug 23, 2017
Primary completionActual
Jan 12, 2018
CompletionActual
Jan 12, 2018
Last update
Sep 15, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 15, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03279939
Responsible party
Sponsor
First posted
Sep 12, 2017
Start date
Aug 23, 2017
Primary completion
Jan 12, 2018
Completion
Jan 12, 2018
Last update
Sep 15, 2025

Study contacts

David Brown, MD
principal investigator · Retina Consultants Houston

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

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