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
About this trial
This is an interventional other trial for Cataract
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
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
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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