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

Cataract Clinical Trial

— BioBase  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05458661
• Other study ID #: B2101CI
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 2022
• Est. completion date: March 2023

Study information

• Verified date: July 2022
• Source: Carl Zeiss Meditec AG
• Contact: Monika Peter, M.Sc.
• Phone: +49 3641 22016
• Email: monika.peter[@]zeiss.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: March 2023
• Est. primary completion date: March 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Astigmatism
• Cataract
• Corneal Astigmatism
• Corneal Defect
• Corneal Deformity
• Lens Opacities

Intervention

Device:
• Clinical Prototype BioBase (SN 07 and SN 08)
Scheimpflug- or OCT based corneal tomographers with the ability to measure anterior and posterior corneal curvature maps >6mm diameter and corneal pachymetry maps >6mm.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Carl Zeiss Meditec AG

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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