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

NCT05458661 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2022-07-14

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Carl Zeiss Meditec AG

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-08-31
Primary Completion
2023-03-31
Completion
2023-03-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05458661 on ClinicalTrials.gov