NCT00842959

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Feb 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2009

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

February 11, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 12, 2009

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

June 16, 2011

Status Verified

June 1, 2011

Enrollment Period

1.9 years

First QC Date

February 11, 2009

Last Update Submit

June 15, 2011

Conditions

Cataract

Keywords

Improvement of adjustment accuracy of intraocular lenses and imaging quality

Outcome Measures

Primary Outcomes (2)

  • Accuracy of prediction of target refraction

    postop.

  • Difference between calculated and measured contrast vision.

    postop.

Study Arms (1)

ZO

OTHER

XL Stabi ZO or Invent ZO

Device: Invent ZODevice: XL Stabi ZO

Interventions

Invent ZODEVICE

monofocal aspheric IOL for implantation into capsular bag

ZO
XL Stabi ZODEVICE

monofocal aspheric IOL for implantation into capsular bag

ZO

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Indication for cataract operation
  • Written informed consent of patient after information

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitäts-Augenklinik Mainz

Mainz, 55131, Germany

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Study Officials

  • Jochen Wahl, MD

    Universitäts-Augenklinik Mainz

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 11, 2009

First Posted

February 12, 2009

Study Start

February 1, 2009

Primary Completion

January 1, 2011

Study Completion

January 1, 2011

Last Updated

June 16, 2011

Record last verified: 2011-06

Locations

DE(1)