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

NCT ID: NCT05458661

Last Updated: 2022-07-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-31

Study Completion Date

2023-03-31

Brief Summary

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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

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Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

all suitable/eligible subjects will undergo a series of biometry measurements
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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recruited patient population

Group Type OTHER

Clinical Prototype BioBase (SN 07 and SN 08)

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Other Intervention Names

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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)

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Carl Zeiss Meditec AG

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Monika Peter, M.Sc.

Role: CONTACT

+49 3641 22016

Other Identifiers

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B2101CI

Identifier Type: -

Identifier Source: org_study_id

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