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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cataract; Corneal Astigmatism; Corneal Defect; Corneal Deformity; Lens Opacities; Artificial Lens Implant
• Intervention / Treatment: Device: Clinical Prototype BioBase (SN 07 and SN 08)

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Monika Peter, M.Sc.; Phone Number: +49 3641 22016; Email: monika.peter@zeiss.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: recruited patient population

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.; Other Names: 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)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Carl Zeiss Meditec AG

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2022
• Primary Completion (Anticipated): March 1, 2023
• Study Completion (Anticipated): March 1, 2023

Study Registration Dates

• First Submitted: April 5, 2022
• First Submitted That Met QC Criteria: July 12, 2022
• First Posted (Actual): July 14, 2022

Study Record Updates

• Last Update Posted (Actual): July 14, 2022
• Last Update Submitted That Met QC Criteria: July 12, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Refractive Errors; Cataract; Astigmatism
• Other Study ID Numbers: B2101CI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: no publications planned

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No