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

Cataract Clinical Trial

— ZO Okulix  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00842959
• Other study ID #: Acri.Tec-RES-DE-273
• Status: Completed
• Phase: Phase 4
• First received: February 11, 2009
• Last updated: June 15, 2011
• Start date: February 2009
• Est. completion date: January 2011

Study information

• Verified date: June 2011
• Source: Carl Zeiss Meditec AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cataract

Intervention

Device:
• Invent ZO
monofocal aspheric IOL for implantation into capsular bag
• XL Stabi ZO
monofocal aspheric IOL for implantation into capsular bag

Locations

Country	Name	City	State
Germany	Universitäts-Augenklinik Mainz	Mainz

Sponsors (1)

Lead Sponsor	Collaborator
Carl Zeiss Meditec AG

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accuracy of prediction of target refraction		postop.
Primary	Difference between calculated and measured contrast vision.		postop.