Normal EyesNCT04961398
Evaluation of Heidelberg Engineering SPECTRALIS OCT Signal to Noise Ratio Effect on Parameter Measurements
An observational study of Normal Eyes, run by Heidelberg Engineering GmbH at 1 site in United States.
Trial summary
Evaluation of effect of various OCT scan speeds and filters on parameter measurements. Read more about this study
- Who is it for?
- Ages 22 years and olderHealthy volunteers can take part
- Conditions the study is for
- Normal Eyes
- What is being tested?
- OCT imaging
- Type of treatment
- Medical device
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jun 2021to 24 Jun 2021
- 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
Who may be able to join
- Able and willing to undergo the test procedures, sign informed consent, and follow instructions.
- Age ≥ 22
- Both eyes with an age-appropriate normal appearing OCT as determined by an investigator
Who cannot join
- Subjects unable to read or write
- Subjects with ocular media not sufficiently clear to obtain acceptable study-related imaging as determined by OCT imaging (without neutral optical density filter)
- Subjects who cannot tolerate the imaging procedures
Trial locations and contacts
1 site in 1 country.
United States1 site
Heidelberg Engineering, Inc.
Franklin, Massachusetts, 02038
About this study
Evaluation of effect of various OCT scan speeds and filters on parameter measurements.
Read the detailed description
The objectives of this study are to
- Directly compare parameter measurements generated on scans acquired at different speed modes with various levels of signal-to-noise ratio (SNR).
- Evaluate the effects of SNR, as determined by the device's Q score, on parameters derived from segmentation results, i.e., thickness of peripapillary retinal nerve fiber layer on circle scans (pRNFL), minimum rim width of optical nerve head (MRW), and macular layer thicknesses (Retina, GCL, IPL).
- Conditions
- Normal Eyes
- Being tested
- OCT imaging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OCT imagingDevice
OCT imaging on Normal Eyes without any filter and with various ND filters as per protocol
| Study group | Role | What they receive |
|---|---|---|
| OCT speed 85 KHz | predicate speed Receives: Device: OCT imaging | |
| OCT speed 125 KHz | investigational speed Receives: Device: OCT imaging | |
| OCT speed 20 KHz | investigational speed Receives: Device: OCT imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Macular layer thicknesses
ETDRS grid (9 sectors)
Measured: during the intervention
Bruch's Membrane Opening (BMO)-Minimum Rim Width (MRW)
Classification chart (6 sectors)
Measured: during the intervention
Peripapillary Retinal Nerve Fiber Layer Thickness (RNFLT)
Classification chart (6 sectors)
Measured: during the intervention
Secondary outcomes (1)
Adverse Events
All AEs
Measured: through study completion, an average of one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2021
- Study start21 Jun 2021
- Primary completion24 Jun 2021
- Study completion24 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Normal EyesStudies 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
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heidelberg Engineering GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Valerie M Leung, BOptom BS, Principal investigator, Heidelberg Engineering, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04961398
- Sponsor's protocol ID
- S-2021-1
- Status last verified
- Sep 2025
- First submitted
- 17 Jun 2021
- Last updated
- 16 Sep 2025
- Results posted
- 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 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Heidelberg Engineering SPECTRALIS OCT Signal to Noise Ratio Effect on Parameter Measurements
- ClinicalTrials.gov ID
- NCT04961398
- Acronym / sponsor ID
- S-2021-1
- Conditions
- Normal Eyes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Heidelberg Engineering GmbHIndustry (pharma, biotech, devices)
- Study start
- 21 Jun 2021 (actual)
- Primary completion
- 24 Jun 2021 (actual)
- Study completion
- 24 Jun 2021 (actual)
- First posted
- 14 Jul 2021 (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.
Evaluation of effect of various OCT scan speeds and filters on parameter measurements.
Detailed description
The objectives of this study are to
- Directly compare parameter measurements generated on scans acquired at different speed modes with various levels of signal-to-noise ratio (SNR).
- Evaluate the effects of SNR, as determined by the device's Q score, on parameters derived from segmentation results, i.e., thickness of peripapillary retinal nerve fiber layer on circle scans (pRNFL), minimum rim width of optical nerve head (MRW), and macular layer thicknesses (Retina, GCL, IPL).
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| OCT speed 85 KHz | – | Device: OCT imagingpredicate speed |
| OCT speed 125 KHz | – | Device: OCT imaginginvestigational speed |
| OCT speed 20 KHz | – | Device: OCT imaginginvestigational speed |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- adults with healthy eyes
Key inclusion criteria (3 listed)
- Able and willing to undergo the test procedures, sign informed consent, and follow instructions.
- Age ≥ 22
- Both eyes with an age-appropriate normal appearing OCT as determined by an investigator
Key exclusion criteria (3 listed)
- Subjects unable to read or write
- Subjects with ocular media not sufficiently clear to obtain acceptable study-related imaging as determined by OCT imaging (without neutral optical density filter)
- Subjects who cannot tolerate the imaging procedures
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 |
|---|---|---|
| OCT imagingOCT imaging on Normal Eyes without any filter and with various ND filters as per protocol | Device | OCT speed 125 KHz, OCT speed 20 KHz, OCT speed 85 KHz |
Primary outcome
Macular layer thicknesses
Time frame: during the intervention
ETDRS grid (9 sectors)
Bruch's Membrane Opening (BMO)-Minimum Rim Width (MRW)
Time frame: during the intervention
Classification chart (6 sectors)
Peripapillary Retinal Nerve Fiber Layer Thickness (RNFLT)
Time frame: during the intervention
Classification chart (6 sectors)
1 secondary outcome
Adverse Events
Time frame: through study completion, an average of one 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 16 Sep 2025.
- Individual participant dataSharing planned: No
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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.
Valerie M Leung, BOptom BS principal investigator
Heidelberg Engineering, Inc.
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 Normal 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 3 inclusion and 3 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 16 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?
Macular layer thicknesses (time frame: during the intervention). 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 16 Sep 2025.