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Night Driving Pilot

NCT ID: NCT00876278

Last Updated: 2013-11-28

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

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2010-02-28

Brief Summary

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Pilot study to evaluate usability of Mesotest II for assessment of night driving capacity of pseudo-phakic patients implanted with aspheric monofocal posterior chamber IOL \*AT.Smart 46LC.

Target Criterion:

Measurement of contrast sensitivity and sensitivity to light under mesopic conditions (Mesotest II, Oculus).

Detailed Description

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Conditions

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Cataract

Keywords

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Cataract Intraocular Lens (IOL) Mesotest II Evaluation of usability of Mesotest II for assessment of night driving capacity of pseudo-phakic patients

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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*AT.Smart 46LC

The \*AT.Smart 46LC is indicated for primary implantation for the visual correction of aphakia in persons in whom the cataractous lens has been removed by phacoemulsification extracapsular cataract extraction. The IOL is intended to be placed only in an intact capsular bag. When implanted, the \*AT.Smart 46LC replaces the natural lens of the eye and functions as a refracting medium in the correction of aphakia.

Group Type OTHER

*AT.Smart 46LC

Intervention Type DEVICE

Primary implantation of \*AT.Smart 46 LC into the eye's capsular bag for the visual correction of aphakia in persons in whom the cataractous lens has been removed by phacoemulsification extracapsular cataract extraction. The IOL is intended to be placed only in an intact capsular bag. When implanted, the \*AT.Smart 46LC replaces the natural lens of the eye and functions as a refracting medium in the correction of aphakia.

Interventions

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*AT.Smart 46LC

Primary implantation of \*AT.Smart 46 LC into the eye's capsular bag for the visual correction of aphakia in persons in whom the cataractous lens has been removed by phacoemulsification extracapsular cataract extraction. The IOL is intended to be placed only in an intact capsular bag. When implanted, the \*AT.Smart 46LC replaces the natural lens of the eye and functions as a refracting medium in the correction of aphakia.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Healthy eyes with cataract
* Patient age 50-75 years
* Written Patient Informed Consent
* Assured follow-up examination

Exclusion Criteria

* Any kind of macula degeneration and impairment of retina (clinical diagnosis)
* Amblyopia
* Intraoperative complications; damaged posterior bag; intraocular haemorrhage
* Astigmatism \> 1.5 D (objective, preoperative)
* Pregnancy or lactation period for female patients
Minimum Eligible Age

50 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Carl Zeiss Meditec AG

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Arthur J. Mueller, MD

Role: PRINCIPAL_INVESTIGATOR

Klinikum Augsburg, Klinik für Augenheilkunde

Locations

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Klinikum Augsburg, Klinik für Augenheilkunde

Augsburg, , Germany

Site Status

Countries

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Germany

Other Identifiers

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46LC HEN 401-08

Identifier Type: -

Identifier Source: org_study_id