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

This study has been completed.
Sponsor:
Information provided by:
Carl Zeiss Meditec AG
ClinicalTrials.gov Identifier:
NCT00842959
First received: February 11, 2009
Last updated: June 15, 2011
Last verified: June 2011
  Purpose

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 Intervention Phase
Cataract
Device: Invent ZO
Device: XL Stabi ZO
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Carl Zeiss Meditec AG:

Primary Outcome Measures:
  • Accuracy of prediction of target refraction [ Time Frame: postop. ] [ Designated as safety issue: No ]
  • Difference between calculated and measured contrast vision. [ Time Frame: postop. ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: February 2009
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00842959

Locations
Germany
Universitäts-Augenklinik Mainz
Mainz, Germany, 55131
Sponsors and Collaborators
Carl Zeiss Meditec AG
Investigators
Principal Investigator: Jochen Wahl, MD Universitäts-Augenklinik Mainz
  More Information

No publications provided

Responsible Party: Andreas Langer, Acri.Tec GmbH
ClinicalTrials.gov Identifier: NCT00842959     History of Changes
Other Study ID Numbers: Acri.Tec-RES-DE-273
Study First Received: February 11, 2009
Last Updated: June 15, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Carl Zeiss Meditec AG:
Improvement of adjustment accuracy of intraocular lenses and imaging quality

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases

ClinicalTrials.gov processed this record on August 28, 2014