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

July 12, 2022 updated by: Carl Zeiss Meditec AG

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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Data collection for algorithm development - Cornea to retina Scan
Time Frame: 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.
day 1
Data collection for algorithm development - Corneal topography
Time Frame: 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.
day 1
Data collection for algorithm development - - Anterior-segment OCT data
Time Frame: 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.
day 1
Data collection for algorithm development - Extended retina-scan
Time Frame: 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.
day1
Data collection for algorithm development - Reference pictures for markerless alignment of toric IOL (sclera images)
Time Frame: 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.
day 1
Data collection for algorithm development - White-to-white determination
Time Frame: 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.
day 1
Data collection for algorithm development - IOL Imaging pictures
Time Frame: 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.
day 1
Affected measurements - OCT measurements
Time Frame: 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
day 1
Affected measurements - Keratometry and Topography measurements
Time Frame: 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
day 1
Affected measurements - - WTW measurements
Time Frame: 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
day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Carl Zeiss Meditec AG

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 5, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 12, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 14, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 14, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 12, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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