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

Not Applicable

• Conditions: Artificial Lens Implant; Corneal Deformity; Lens Opacities; Corneal Astigmatism; Cataract; Corneal Defect
• Interventions: Device: Clinical Prototype BioBase (SN 07 and SN 08)

• Registration Number: NCT05458661
• Lead Sponsor: Carl Zeiss Meditec AG

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-04-05
• Status Verified: 2022-07
• Study First Submitted QC: 2022-07-12
• Last Update Submitted: 2022-07-12
• Study First Posted: 2022-07-14
• Last Update Posted: 2022-07-14
• Study Start: 2022-08
• Primary Completion: 2023-03
• Study Completion: 2023-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
recruited patient population	Clinical Prototype BioBase (SN 07 and SN 08)	-

Primary Outcome Measures

Name	Time	Method
Data collection for algorithm development - Cornea to retina Scan	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	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	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	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)	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	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	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 - - WTW measurements	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
Affected measurements - Keratometry and Topography measurements	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 - OCT measurements	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