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

NCT05458661 | Unknown

• 1 other identifier: B2101CI
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cataract; Lens Opacities; Artificial Lens Implant; Corneal Astigmatism; Corneal Defect; Corneal Deformity

Outcome Measures

Primary Outcomes (10)

• 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

Study Arms (1)

recruited patient population

OTHER

Device: Clinical Prototype BioBase (SN 07 and SN 08)

Interventions

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.

Also known as: 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)

recruited patient population

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Carl Zeiss Meditec AG: lead

MeSH Terms

Conditions

Cataract; Astigmatism

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases; Refractive Errors

Central Study Contacts

Monika Peter, M.Sc.

CONTACT

+49 3641 22016; monika.peter@zeiss.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: all suitable/eligible subjects will undergo a series of biometry measurements

Study Record Dates

• First Submitted: April 5, 2022
• First Posted: July 14, 2022
• Study Start: August 1, 2022
• Primary Completion: March 1, 2023
• Study Completion: March 1, 2023
• Last Updated: July 14, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share