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OpenTrials
Completed

NCT Number: NCT00842959

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

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.

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Key information

Conditions

Cataract Eye Diseases Lens Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Universitäts-Augenklinik Mainz

Mainz, 55131, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Invent ZO

Device

monofocal aspheric IOL for implantation into capsular bag

XL Stabi ZO

Device

monofocal aspheric IOL for implantation into capsular bag

Primary outcomes

  1. Accuracy of prediction of target refraction

    Time frame: postop.

  2. Difference between calculated and measured contrast vision.

    Time frame: postop.

Sponsors and collaborators

Lead sponsor

Carl Zeiss Meditec AG

Industry

Registry information

Official study title

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

Acronym: ZO Okulix

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Feb 12, 2009
Registry last updated
Jun 16, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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