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

Study Overview
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Brief Summary
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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.

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

Conditions
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Cataract, Lens Opacities, Artificial Lens Implant, Corneal Astigmatism, Corneal Defect, Corneal Deformity

Intervention / Treatment
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* Device: Clinical Prototype BioBase (SN 07 and SN 08)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: all suitable/eligible subjects will undergo a series of biometry measurements
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: recruited patient population<br> | Device: Clinical Prototype BioBase (SN 07 and SN 08)<br>* Scheimpflug- or OCT based corneal tomographers with the ability to measure anterior and posterior corneal curvature maps >6mm diameter and corneal pachymetry maps >6mm.<br>* Other names: MS-39 (bon Optic Vertriebsges. mbH, Stellmacherstraße 14, 23556 Lübeck);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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 | 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 | 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 | day 1 |