Retinal DiseaseNCT04661124
Evaluation of the Heidelberg Engineering SPECTRALIS With Flex Module for In-vivo Imaging in the Supine Position
An observational study of Retinal Disease and Healthy Eyes, run by Heidelberg Engineering GmbH at 1 site in United States.
Trial summary
This is a prospective clinical study conducted at one clinical site in the United States. Read more about this study
- Who is it for?
- Ages 22 years and olderHealthy volunteers can take part
- Conditions the study is for
- Retinal Disease, Healthy Eyes
- What is being tested?
- SPECTRALIS and SPECTRALIS with Flex Module
- Type of treatment
- Medical device
- How many people
- 88 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Dec 2020to 22 Apr 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults with healthy eyes (AN), and adults with structural and vascular retinal abnormalities (AD)
Who may be able to join
- Age ≥ 22 years
- Able and willing to undergo the test procedures, sign informed consent, and follow instructions.
- Physically able to be positioned in all required imaging positions (upright at chinrest and supine).
- Able to fixate.
- Best corrected visual acuity ≥ 20/40 in both eyes.
- Age ≥ 22 years
Show all 10Show fewer
- Able and willing to undergo the test procedures, sign informed consent, and follow instructions.
- Physically able to be positioned in all required imaging positions (upright at chinrest and supine).
- Able to fixate.
- Eye with a structural and vascular posterior segment abnormality due to ocular disease and/or trauma.
Who cannot join
- Eye with ocular media not sufficiently clear to obtain acceptable study-related imaging.
- Subjects who cannot tolerate the imaging procedures.
- Clinically significant ocular disease in either eye as determined by an Investigator.
- Ocular surgical intervention (except for refractive laser surgery or cataract surgery) in either eye.
- Adult Posterior Segment Abnormality Eye Population (AD)
- Eye with ocular media not sufficiently clear to obtain acceptable study-related imaging.
- Subjects who cannot tolerate the imaging procedures.
Trial locations and contacts
1 site in 1 country.
About this study
This is a prospective clinical study conducted at one clinical site in the United States.
Read the detailed description
The conducted study is an observational study for an imaging device used in the aid of ophthalmology diagnosis.
- Conditions
- Retinal Disease, Healthy Eyes
- Being tested
- SPECTRALIS, SPECTRALIS with Flex Module
- Medical subject headings
- Retinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPECTRALISDevice
Also called SPECTRALIS HRA+OCT (and variants) with OCT Angiography Module
ophthalmic imaging device with head and chinrest
SPECTRALIS with Flex ModuleDevice
Also called SPECTRALIS HRA+OCT (and variants) with Flex Module
ophthalmic imaging device on mobile instrumentation stand
| Study group | Role | What they receive |
|---|---|---|
| Adult Normal Eyes | see Inclusion/Exclusion criteria; imaged with OCT and/or OCTA Receives: Device: SPECTRALIS; Device: SPECTRALIS with Flex Module | |
| Adult Pathology Eyes | see Inclusion/Exclusion criteria; imaged with OCT and/or OCTA Receives: Device: SPECTRALIS; Device: SPECTRALIS with Flex Module |
What is being measured
The primary outcome is the main question the study is designed to answer.
The image quality grade of the acquired images as determined by an independent reading center
OCT, OCTA and IR cSLO - graded Good (2)/Average (1)/Poor (0)
Measured: through study completion, average of 1 day
Agreement in identification of abnormalities of the acquired Standard OCT images between the devices
based on pre-specified abnormalities
Measured: through study completion, average of 1 day
Agreement in identification of abnormalities of the acquired OCTA images between the devices
based on pre-specified abnormalities
Measured: through study completion, average of 1 day
Secondary outcomes (1)
Adverse events
All AEs
Measured: through study completion, average of 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2020
- Study start10 Dec 2020
- Primary completion17 Sep 2021
- Study completion22 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retinal DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heidelberg Engineering GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Duke University
- Responsible party
- Sponsor
- Investigators
- Lejla Vajzovic, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04661124
- Sponsor's protocol ID
- S-2018-3
- Status last verified
- Sep 2025
- First submitted
- 3 Dec 2020
- Last updated
- 15 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Heidelberg Engineering SPECTRALIS With Flex Module for In-vivo Imaging in the Supine Position
- ClinicalTrials.gov ID
- NCT04661124
- Acronym / sponsor ID
- S-2018-3
- Conditions
- Retinal Disease, Healthy Eyes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Heidelberg Engineering GmbHIndustry (pharma, biotech, devices)
- Collaborators
- Duke University
- Study start
- 10 Dec 2020 (actual)
- Primary completion
- 17 Sep 2021 (actual)
- Study completion
- 22 Apr 2024 (actual)
- First posted
- 10 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective clinical study conducted at one clinical site in the United States.
Detailed description
The conducted study is an observational study for an imaging device used in the aid of ophthalmology diagnosis.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adult Normal Eyes | – | Device: SPECTRALIS, Device: SPECTRALIS with Flex Modulesee Inclusion/Exclusion criteria; imaged with OCT and/or OCTA |
| Adult Pathology Eyes | – | Device: SPECTRALIS, Device: SPECTRALIS with Flex Modulesee Inclusion/Exclusion criteria; imaged with OCT and/or OCTA |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with healthy eyes (AN), and adults with structural and vascular retinal abnormalities (AD)
Key inclusion criteria (10 listed)
- Age ≥ 22 years
- Able and willing to undergo the test procedures, sign informed consent, and follow instructions.
- Physically able to be positioned in all required imaging positions (upright at chinrest and supine).
- Able to fixate.
- Best corrected visual acuity ≥ 20/40 in both eyes.
Key exclusion criteria (7 listed)
- Eye with ocular media not sufficiently clear to obtain acceptable study-related imaging.
- Subjects who cannot tolerate the imaging procedures.
- Clinically significant ocular disease in either eye as determined by an Investigator.
- Ocular surgical intervention (except for refractive laser surgery or cataract surgery) in either eye.
- Adult Posterior Segment Abnormality Eye Population (AD)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SPECTRALISAlso: SPECTRALIS HRA+OCT (and variants) with OCT Angiography Moduleophthalmic imaging device with head and chinrest | Device | Adult Normal Eyes, Adult Pathology Eyes |
| SPECTRALIS with Flex ModuleAlso: SPECTRALIS HRA+OCT (and variants) with Flex Moduleophthalmic imaging device on mobile instrumentation stand | Device | Adult Normal Eyes, Adult Pathology Eyes |
Primary outcome
The image quality grade of the acquired images as determined by an independent reading center
Time frame: through study completion, average of 1 day
OCT, OCTA and IR cSLO - graded Good (2)/Average (1)/Poor (0)
Agreement in identification of abnormalities of the acquired Standard OCT images between the devices
Time frame: through study completion, average of 1 day
based on pre-specified abnormalities
Agreement in identification of abnormalities of the acquired OCTA images between the devices
Time frame: through study completion, average of 1 day
based on pre-specified abnormalities
1 secondary outcome
Adverse events
Time frame: through study completion, average of 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2025.
- Individual participant dataSharing planned: No
Related trials for Retinal Disease
Active, not recruitingPhase 4
A Study About the Safety of ASP3021 Eye Injections and if They Help People in Japan With Vision Loss From Age-related Macular Degeneration
Geographic Atrophy, Age-Related Macular Degeneration
RecruitingPhase 2
A Proof-Of-Concept (POC) Study of SFG-02 Transdermal Formulation in Participants With Underactive Bladder (UAB)
Participants With Underactive Bladder (UAB)
RecruitingObservational study
Age-Related Macular Degeneration Benchmark Imaging Dataset (ABID)
Age-Related Macular Degeneration
Active, not recruitingPhase 1/2
Study to Assess the Safety and Efficacy of OCU410 for Geographic Atrophy
Geographic Atrophy
RecruitingPhase 3
A Phase 3 Trial for Intravitreal Injection of 4D-150 in Adults With Diabetic Macular Edema (DME).
Diabetic Macular Edema (DME)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lejla Vajzovic, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Retinal Disease and Healthy Eyes, run by Heidelberg Engineering GmbH at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The image quality grade of the acquired images as determined by an independent reading center (time frame: through study completion, average of 1 day). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2025.