Check of Optical Features and Accuracy of the Zeiss ZO Le... | NCT00842959

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

NCT00842959

Sponsor

Carl Zeiss Meditec AG

Status

Completed

Last Update Posted

Jun 16, 2011Estimated

Enrollment

120Estimated

Phase

Phase 4

Conditions

Cataract

Interventions

Invent ZO
XL Stabi ZO

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2009

Primary Completion Date

Jan 2011Actual

Completion Date

Jan 2011Actual

First Submitted Date

Feb 11, 2009

First Submission Date that Met QC Criteria

Feb 11, 2009

First Posted Date

Feb 12, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 15, 2011

Last Update Posted Date

Jun 16, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ZO	Other	XL Stabi ZO or Invent ZO	Device: Invent ZO Device: XL Stabi ZO

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Invent ZO	Device	monofocal aspheric IOL for implantation into capsular bag	ZO

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Accuracy of prediction of target refraction		postop.
Difference between calculated and measured contrast vision.		postop.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jochen Wahl, MD	Universitäts-Augenklinik Mainz	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Universitäts-Augenklinik Mainz		Mainz		55131	Germany

Type	Date	Date Unknown
Release	Nov 27, 2013
Reset	Jan 24, 2014

Submission Tracking

Estimated Results First Submitted Date

Nov 27, 2013

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Nov 27, 2013			Jan 24, 2014

Condition Browse Module

MeSH Terms

ID	Term
D002386	Cataract

Ancestor Terms

ID	Term
D007905	Lens Diseases
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided