Study of Clinical Performance of Corneal Topography Measurement Using an Optical Biometer

NCT ID: NCT01861925

Last Updated: 2014-06-05

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-06-30

Study Completion Date

2013-07-31

Brief Summary

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The purpose of this study is to quantify in-vivo repeatability of a new corneal topography measurement mode of an optical biometer, and the clinical performance of measurement in comparison to reference devices.

Detailed Description

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Conditions

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Corneal Topography

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Normal eye

Astigmatism smaller than 1.5 diopters

No interventions assigned to this group

Large regular astigmatism

Astigmatism of \> 1.5 diopters, regular astigmatism.

No interventions assigned to this group

Large irregular astigmatism

Astigmatism of \> 1.5 diopters, irregular astigmatism.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* 18 years or older

Exclusion Criteria

* No corneal transplants
* No corneal scar(s)
* No acute infections of the eye
* No weak fixation
* No suspected lack of compliance
* No vulnerable population
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role collaborator

Haag-Streit AG

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Beatrice Frueh, Prof. Fr.

Role: PRINCIPAL_INVESTIGATOR

Insel Gruppe AG, University Hospital Bern

Locations

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University Hospital Inselspital

Bern, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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HS-LS900-TOPO-01

Identifier Type: -

Identifier Source: org_study_id

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