NCT00365677

Brief Summary

The objective of this study was to compare the safety and effectiveness of two versions of the Bausch \& Lomb Zyoptix Tissue Saving Aspheric Algorithm versus the current Zyoptix Tissue Saving Algorithm when used for myopia and myopic astigmatism LASIK treatment.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
127

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2005

Shorter than P25 for not_applicable

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

October 1, 2005

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2006

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 30, 2006

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 17, 2006

Completed
Last Updated

December 8, 2011

Status Verified

December 1, 2011

Enrollment Period

5 months

First QC Date

June 30, 2006

Last Update Submit

December 7, 2011

Conditions

MyopiaAstigmatism

Outcome Measures

Primary Outcomes (2)

  • Uncorrected visual acuity

    At 90 days post surgery

  • Preservation of best spectacle corrected high contrast logMAR distance visual acuity compared to baseline.

    At 90 days post surgery

Secondary Outcomes (2)

  • Deviation from target correction

    At 90 days post surgery

  • Improvement in uncorrected distance high contrast logMAR visual acuity compared to baseline

    At 90 days post surgery

Study Arms (2)

Zyoptix Tissue Saving Aspheric

EXPERIMENTAL

The Bausch \& Lomb Zyoptix Tissue Saving Aspheric algorithm is used for treatment with LASIK for the correction of myopia and myopic astigmatism.

Device: The Bausch & Lomb Zyoptix Tissue Saving Aspheric algorithm

Zyoptix Tissue Saving

ACTIVE COMPARATOR

The Bausch \& Lomb Zyoptix Tissue Saving algorithm is used for treatment with LASIK for the correction of myopia and myopic astigmatism.

Device: The Bausch & Lomb Zyoptix Tissue Saving algorithm

Interventions

The Bausch & Lomb Zyoptix Tissue Saving Aspheric algorithmDEVICE

Used with LASIK treatment for the correction of myopia and myopic astigmatism.

Zyoptix Tissue Saving Aspheric
The Bausch & Lomb Zyoptix Tissue Saving algorithmDEVICE

Used with LASIK treatment for the correction of myopia and myopic astigmatism.

Zyoptix Tissue Saving

Eligibility Criteria

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

You may qualify if:

  • Myopia with or without astigmatism.
  • Normal Corneal topography
  • Willing to have both eyes treated with the laser.

You may not qualify if:

  • Contraindications to LASIK.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

MyopiaAstigmatism

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Study Officials

  • Joanne Egamino, PhD

    Bausch & Lomb Incorporated

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 30, 2006

First Posted

August 17, 2006

Study Start

October 1, 2005

Primary Completion

March 1, 2006

Study Completion

March 1, 2006

Last Updated

December 8, 2011

Record last verified: 2011-12