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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| recruited patient population | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clinical Prototype BioBase (SN 07 and SN 08) | Device | Scheimpflug- or OCT based corneal tomographers with the ability to measure anterior and posterior corneal curvature maps >6mm diameter and corneal pachymetry maps >6mm. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Monika Peter, M.Sc. | Contact | +49 3641 22016 | monika.peter@zeiss.com |
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no publications planned
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all suitable/eligible subjects will undergo a series of biometry measurements
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|
- 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 |
| ID | Term |
|---|---|
| D002386 | Cataract |
| D001251 | Astigmatism |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
| D012030 | Refractive Errors |
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