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Feasibility Investigation of Biometry and Tomography Measurements in a Heterogeneous Patient Cohort (BioBase)

Primary Purpose

Cataract, Lens Opacities, Artificial Lens Implant

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Clinical Prototype BioBase (SN 07 and SN 08)
Sponsored by
Carl Zeiss Meditec AG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Cataract

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    recruited patient population

    Arm Description

    Outcomes

    Primary Outcome Measures

    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.
    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.
    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.
    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.
    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.
    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.
    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.
    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
    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
    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

    Secondary Outcome Measures

    Full Information

    First Posted
    April 5, 2022
    Last Updated
    July 12, 2022
    Sponsor
    Carl Zeiss Meditec AG
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05458661
    Brief Title
    Feasibility Investigation of Biometry and Tomography Measurements in a Heterogeneous Patient Cohort
    Acronym
    BioBase
    Official Title
    Feasibility Investigation of Biometry and Tomography Measurements in a Heterogeneous Patient Cohort (BioBase)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 2022 (Anticipated)
    Primary Completion Date
    March 2023 (Anticipated)
    Study Completion Date
    March 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Carl Zeiss Meditec AG

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cataract, Lens Opacities, Artificial Lens Implant, Corneal Astigmatism, Corneal Defect, Corneal Deformity

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    all suitable/eligible subjects will undergo a series of biometry measurements
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    recruited patient population
    Arm Type
    Other
    Intervention Type
    Device
    Intervention Name(s)
    Clinical Prototype BioBase (SN 07 and SN 08)
    Other Intervention Name(s)
    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)
    Intervention Description
    Scheimpflug- or OCT based corneal tomographers with the ability to measure anterior and posterior corneal curvature maps >6mm diameter and corneal pachymetry maps >6mm.
    Primary Outcome Measure Information:
    Title
    Data collection for algorithm development - Cornea to retina Scan
    Description
    - 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.
    Time Frame
    day 1
    Title
    Data collection for algorithm development - Corneal topography
    Description
    - 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.
    Time Frame
    day 1
    Title
    Data collection for algorithm development - - Anterior-segment OCT data
    Description
    - 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.
    Time Frame
    day 1
    Title
    Data collection for algorithm development - Extended retina-scan
    Description
    - 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.
    Time Frame
    day1
    Title
    Data collection for algorithm development - Reference pictures for markerless alignment of toric IOL (sclera images)
    Description
    - 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.
    Time Frame
    day 1
    Title
    Data collection for algorithm development - White-to-white determination
    Description
    - 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.
    Time Frame
    day 1
    Title
    Data collection for algorithm development - IOL Imaging pictures
    Description
    - 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.
    Time Frame
    day 1
    Title
    Affected measurements - OCT measurements
    Description
    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
    Time Frame
    day 1
    Title
    Affected measurements - Keratometry and Topography measurements
    Description
    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
    Time Frame
    day 1
    Title
    Affected measurements - - WTW measurements
    Description
    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
    Time Frame
    day 1

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    21 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: 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 Exclusion Criteria: 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Monika Peter, M.Sc.
    Phone
    +49 3641 22016
    Email
    monika.peter@zeiss.com

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    no publications planned

    Learn more about this trial

    Feasibility Investigation of Biometry and Tomography Measurements in a Heterogeneous Patient Cohort

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