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

Sponsor

Carl Zeiss Meditec AG (Industry)

Overall Status

Completed

CT.gov ID

NCT00842959

Collaborator

(none)

120

Enrollment

Location

Arm

Duration (Months)

5.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cataract	Device: Invent ZO Device: XL Stabi ZO	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Official Title:

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

Study Start Date :

Feb 1, 2009

Actual Primary Completion Date :

Jan 1, 2011

Actual Study Completion Date :

Jan 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Other: ZO XL Stabi ZO or Invent ZO	Device: Invent ZO monofocal aspheric IOL for implantation into capsular bag Device: XL Stabi ZO monofocal aspheric IOL for implantation into capsular bag

Arm

Intervention/Treatment

Other: ZO

XL Stabi ZO or Invent ZO

Device: Invent ZO

monofocal aspheric IOL for implantation into capsular bag

Device: XL Stabi ZO

monofocal aspheric IOL for implantation into capsular bag

Outcome Measures

Primary Outcome Measures

Accuracy of prediction of target refraction [postop.]
Difference between calculated and measured contrast vision. [postop.]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Universitäts-Augenklinik Mainz	Mainz		Germany	55131

Sponsors and Collaborators

Carl Zeiss Meditec AG

Investigators

Principal Investigator: Jochen Wahl, MD, Universitäts-Augenklinik Mainz

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00842959

Other Study ID Numbers:

Acri.Tec-RES-DE-273

First Posted:

Feb 12, 2009

Last Update Posted:

Jun 16, 2011

Last Verified:

Jun 1, 2011

Keywords provided by , ,

Improvement of adjustment accuracy of intraocular lenses and imaging quality

Additional relevant MeSH terms:

Cataract

Study Results

No Results Posted as of Jun 16, 2011