Check of Optical Features and Accuracy of the Zeiss ZO Lens After Selection and Calculation With OKULIX

NCT ID: NCT00842959

Last Updated: 2011-06-16

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

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2011-01-31

Brief Summary

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It is planned to implant the intraocular lenses XL Stabi ZO and Invent ZO into the eyes of patients for whom a cataract operation is medically indicated. The lenses are marketed and CE certified. Their implantation is clinical routine.

In the trial the accuracy of prediction of target refraction and the difference between calculated and measured contrast vision will be examined for both lens types.

Detailed Description

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Conditions

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Cataract

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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ZO

XL Stabi ZO or Invent ZO

Group Type OTHER

Invent ZO

Intervention Type DEVICE

monofocal aspheric IOL for implantation into capsular bag

XL Stabi ZO

Intervention Type DEVICE

monofocal aspheric IOL for implantation into capsular bag

Interventions

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Invent ZO

monofocal aspheric IOL for implantation into capsular bag

Intervention Type DEVICE

XL Stabi ZO

monofocal aspheric IOL for implantation into capsular bag

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Indication for cataract operation
* Written informed consent of patient after information

Exclusion Criteria

* Immobility
* Limited capacity of understanding
* Diseases that hamper a follow-up examination
* Astigmatism \>2.0 D
* Patients with ocular diseases who may be expected to show a vision of less than 0.63 (decimal) two months after cataract surgery with implantation of intraocular lens
* Complications during surgery, especially complications with positioning of the intraocular lens and with capsulorhexis
Minimum Eligible Age

18 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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Acri.Tec GmbH

Principal Investigators

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Jochen Wahl, MD

Role: PRINCIPAL_INVESTIGATOR

Universitäts-Augenklinik Mainz

Locations

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Universitäts-Augenklinik Mainz

Mainz, , Germany

Site Status

Countries

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Germany

Other Identifiers

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Acri.Tec-RES-DE-273

Identifier Type: -

Identifier Source: org_study_id

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