CataractBioBaseNCT05458661
Feasibility Investigation of Biometry and Tomography Measurements in a Heterogeneous Patient Cohort
A study testing Clinical Prototype BioBase (SN 07 and SN 08) in people with Cataract and Lens Opacities, run by Carl Zeiss Meditec AG.
Trial summary
The planned clinical investigation will be conducted to acquire raw data for the development of the algorithm. The data acquisition is intended to obtain first impressions of the potential performance of the changed hardware and software components and to confirm the safety profile assessed by risk analysis. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cataract, Lens Opacities, Artificial Lens Implant
- What is being tested?
- Clinical Prototype BioBase (SN 07 and SN 08)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Aug 2022to Mar 2023
- Phase
- Interventional
- 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female 21 years of age and older
- Able and willing to make the required study visit
- Able and willing to provide consent and follow study instructions
- Patients must have understood and signed the informed consent
Who cannot join
- Any performed contact measurements or examinations in which the eye is touched on the same day prior to the investigation measurement
- Physical inability to be positioned at the study devices (e.g. torticollis, head tremor, injuries at forehead or chin, etc.)
- Principal Investigator's determination that the subject is not suitable due to other medical condition (reasons to be listed on eCRF)
- Known Pregnancy
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Feasibility Investigation of Biometry and Tomography Measurements in a Heterogeneous Patient Cohort (BioBase)
The planned clinical investigation will be conducted to acquire raw data for the development of the algorithm. The data acquisition is intended to obtain first impressions of the potential performance of the changed hardware and software components and to confirm the safety profile assessed by risk analysis.
- Conditions
- Cataract, Lens Opacities, Artificial Lens Implant, Corneal Astigmatism, Corneal Defect, Corneal Deformity
- Being tested
- Clinical Prototype BioBase (SN 07 and SN 08)
- Medical subject headings
- Cataract, Astigmatism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical Prototype BioBase (SN 07 and SN 08)Device
Also called IOLMaster 700 Vs. 1.90 (Carl Zeiss Meditec AG, Göschwitzer Straße 51-52, 07745 Jena), Pentacam HR (Oculus Optikgeräte GmbH, Münchholzhäuser Straße 29, 35582 Wetzlar), MS-39 (bon Optic Vertriebsges. mbH, Stellmacherstraße 14, 23556 Lübeck)
Scheimpflug- or OCT based corneal tomographers with the ability to measure anterior and posterior corneal curvature maps >6mm diameter and corneal pachymetry maps >6mm.
| Study group | Role | What they receive |
|---|---|---|
| recruited patient population | Other | Not described Receives: Device: Clinical Prototype BioBase (SN 07 and SN 08) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Data collection for algorithm development - Cornea to retina Scan
- Cornea to retina Scan (all axial measurements) The data will be used within the Carl Zeiss Meditec R\&D department to further develop the algorithm of this device to get a next generation biometry device with automated base.
Measured: day 1
Data collection for algorithm development - Corneal topography
- Corneal topography (raw data and images) including keratometry The data will then be used within the Carl Zeiss Meditec R\&D department to further develop the algorithm of this device to get a next generation biometry device with automated base.
Measured: day 1
Data collection for algorithm development - - Anterior-segment OCT data
- Anterior-segment OCT data The data will be used within the Carl Zeiss Meditec R\&D department to further develop the algorithm of this device to get a next generation biometry device with automated base.
Measured: day 1
Data collection for algorithm development - Extended retina-scan
- Extended retina-scan The data will be used within the Carl Zeiss Meditec R\&D department to further develop the algorithm of this device to get a next generation biometry device with automated base.
Measured: day1
Data collection for algorithm development - Reference pictures for markerless alignment of toric IOL (sclera images)
- Reference pictures for markerless alignment of toric IOL (sclera images) The data will be used within the Carl Zeiss Meditec R\&D department to further develop the algorithm of this device to get a next generation biometry device with automated base.
Measured: day 1
Data collection for algorithm development - White-to-white determination
- White-to-white determination The data will then be used within the Carl Zeiss Meditec R\&D department to further develop the algorithm of this device to get a next generation biometry device with automated base.
Measured: day 1
Data collection for algorithm development - IOL Imaging pictures
- IOL Imaging pictures The data will then be used within the Carl Zeiss Meditec R\&D department to further develop the algorithm of this device to get a next generation biometry device with automated base.
Measured: day 1
Affected measurements - OCT measurements
It will be investigated, whether the measurements with the study prototype device are affected by the base movement.
- OCT measurements This outcome will be investigated by comparing the raw data of the study prototype device with the data measured with the marketed IOLMaster 700 and Pentacam / MS-39 devices.
Non-optimal positioning and movement could possibly cause blurred images that would prevent a detailed analysis
Measured: day 1
Affected measurements - Keratometry and Topography measurements
It will be investigated, whether the measurements with the study prototype device are affected by the base movement.
- Keratometry and Topography measurements This outcome will be investigated by comparing the raw data of the study prototype device with the data measured with the marketed IOLMaster 700 and Pentacam / MS-39 devices.
Non-optimal positioning and movement could possibly cause blurred images that would prevent a detailed analysis
Measured: day 1
Affected measurements - - WTW measurements
It will be investigated, whether the measurements with the study prototype device are affected by the base movement.
- WTW measurements This outcome will be investigated by comparing the raw data of the study prototype device with the data measured with the marketed IOLMaster 700 and Pentacam / MS-39 devices.
Non-optimal positioning and movement could possibly cause blurred images that would prevent a detailed analysis
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2022
- Study startAug 2022 (estimated)
- Primary completionMar 2023 (estimated)
- Study completionMar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- all suitable/eligible subjects will undergo a series of biometry measurements
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Carl Zeiss Meditec AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05458661
- Sponsor's protocol ID
- B2101CI
- Acronym
- BioBase
- Status last verified
- Jul 2022
- First submitted
- 5 Apr 2022
- Last updated
- 14 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: no publications planned
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Investigation of Biometry and Tomography Measurements in a Heterogeneous Patient Cohort (BioBase)
- ClinicalTrials.gov ID
- NCT05458661
- Acronym / sponsor ID
- BioBase / B2101CI
- Conditions
- Cataract, Lens Opacities, Artificial Lens Implant, Corneal Astigmatism, Corneal Defect, Corneal Deformity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Carl Zeiss Meditec AGIndustry (pharma, biotech, devices)
- Study start
- Aug 2022 (estimated)
- Primary completion
- Mar 2023 (estimated)
- Study completion
- Mar 2023 (estimated)
- First posted
- 14 Jul 2022 (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.
The planned clinical investigation will be conducted to acquire raw data for the development of the algorithm. The data acquisition is intended to obtain first impressions of the potential performance of the changed hardware and software components and to confirm the safety profile assessed by risk analysis.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- all suitable/eligible subjects will undergo a series of biometry measurements
| Arm | Type | Receives |
|---|---|---|
| recruited patient population | Other | Device: Clinical Prototype BioBase (SN 07 and SN 08) |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female 21 years of age and older
- Able and willing to make the required study visit
- Able and willing to provide consent and follow study instructions
- Patients must have understood and signed the informed consent
Key exclusion criteria (4 listed)
- Any performed contact measurements or examinations in which the eye is touched on the same day prior to the investigation measurement
- Physical inability to be positioned at the study devices (e.g. torticollis, head tremor, injuries at forehead or chin, etc.)
- Principal Investigator's determination that the subject is not suitable due to other medical condition (reasons to be listed on eCRF)
- Known Pregnancy
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 |
|---|---|---|
| Clinical Prototype BioBase (SN 07 and SN 08)Also: IOLMaster 700 Vs. 1.90 (Carl Zeiss Meditec AG, Göschwitzer Straße 51-52, 07745 Jena), Pentacam HR (Oculus Optikgeräte GmbH, Münchholzhäuser Straße 29, 35582 Wetzlar), MS-39 (bon Optic Vertriebsges. mbH, Stellmacherstraße 14, 23556 Lübeck)Scheimpflug- or OCT based corneal tomographers with the ability to measure anterior and posterior corneal curvature maps >6mm diameter and corneal pachymetry maps >6mm. | Device | recruited patient population |
Primary outcome
Data collection for algorithm development - Cornea to retina Scan
Time frame: day 1
- Cornea to retina Scan (all axial measurements) The data will be used within the Carl Zeiss Meditec R\&D department to further develop the algorithm of this device to get a next generation biometry device with automated base.
Data collection for algorithm development - Corneal topography
Time frame: day 1
- Corneal topography (raw data and images) including keratometry The data will then be used within the Carl Zeiss Meditec R\&D department to further develop the algorithm of this device to get a next generation biometry device with automated base.
Data collection for algorithm development - - Anterior-segment OCT data
Time frame: day 1
- Anterior-segment OCT data The data will be used within the Carl Zeiss Meditec R\&D department to further develop the algorithm of this device to get a next generation biometry device with automated base.
Data collection for algorithm development - Extended retina-scan
Time frame: day1
- Extended retina-scan The data will be used within the Carl Zeiss Meditec R\&D department to further develop the algorithm of this device to get a next generation biometry device with automated base.
Data collection for algorithm development - Reference pictures for markerless alignment of toric IOL (sclera images)
Time frame: day 1
- Reference pictures for markerless alignment of toric IOL (sclera images) The data will be used within the Carl Zeiss Meditec R\&D department to further develop the algorithm of this device to get a next generation biometry device with automated base.
Data collection for algorithm development - White-to-white determination
Time frame: day 1
- White-to-white determination The data will then be used within the Carl Zeiss Meditec R\&D department to further develop the algorithm of this device to get a next generation biometry device with automated base.
Data collection for algorithm development - IOL Imaging pictures
Time frame: day 1
- IOL Imaging pictures The data will then be used within the Carl Zeiss Meditec R\&D department to further develop the algorithm of this device to get a next generation biometry device with automated base.
Affected measurements - OCT measurements
Time frame: day 1
It will be investigated, whether the measurements with the study prototype device are affected by the base movement. - OCT measurements This outcome will be investigated by comparing the raw data of the study prototype device with the data measured with the marketed IOLMaster 700 and Pentacam / MS-39 devices. Non-optimal positioning and movement could possibly cause blurred images that would prevent a detailed analysis
Affected measurements - Keratometry and Topography measurements
Time frame: day 1
It will be investigated, whether the measurements with the study prototype device are affected by the base movement. - Keratometry and Topography measurements This outcome will be investigated by comparing the raw data of the study prototype device with the data measured with the marketed IOLMaster 700 and Pentacam / MS-39 devices. Non-optimal positioning and movement could possibly cause blurred images that would prevent a detailed analysis
Affected measurements - - WTW measurements
Time frame: day 1
It will be investigated, whether the measurements with the study prototype device are affected by the base movement. - WTW measurements This outcome will be investigated by comparing the raw data of the study prototype device with the data measured with the marketed IOLMaster 700 and Pentacam / MS-39 devices. Non-optimal positioning and movement could possibly cause blurred images that would prevent a detailed analysis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2022.
- Individual participant dataSharing planned: No. no publications planned
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Clinical Prototype BioBase (SN 07 and SN 08) in people with Cataract and Lens Opacities, run by Carl Zeiss Meditec AG.
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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 14 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Monika Peter, M.Sc. (+49 3641 22016, monika.peter@zeiss.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Data collection for algorithm development - Cornea to retina Scan (time frame: day 1). The study lists 10 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 14 Jul 2022.