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A Study to Investigate the Safety and Effectiveness of Aspheric Laser Refractive Surgery Treatments for Myopia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT00365677
First received: June 30, 2006
Last updated: December 7, 2011
Last verified: December 2011
History of Changes
  Purpose

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.


Condition Intervention
Myopia
Astigmatism
 Device: The Bausch & Lomb Zyoptix Tissue Saving Aspheric algorithm
Device: The Bausch & Lomb Zyoptix Tissue Saving algorithm

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Compare the Safety and Effectiveness of Two Versions of the Bausch & Lomb Zyoptix™ Tissue Saving Aspheric Algorithm to the Current Zyoptix™ Tissue Saving Algorithm When Used for Myopia and Myopic Astigmatism Lasik Treatment

Further study details as provided by Bausch & Lomb Incorporated:

Primary Outcome Measures:
  • Uncorrected visual acuity [ Time Frame: At 90 days post surgery ] [ Designated as safety issue: No ]
  • Preservation of best spectacle corrected high contrast logMAR distance visual acuity compared to baseline. [ Time Frame: At 90 days post surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Deviation from target correction [ Time Frame: At 90 days post surgery ] [ Designated as safety issue: No ]
  • Improvement in uncorrected distance high contrast logMAR visual acuity compared to baseline [ Time Frame: At 90 days post surgery ] [ Designated as safety issue: No ]

Enrollment: 127
Study Start Date: October 2005
Study Completion Date: March 2006
Primary Completion Date: March 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Zyoptix Tissue Saving Aspheric
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
Used with LASIK treatment for the correction of myopia and myopic astigmatism.
Active Comparator: Zyoptix Tissue Saving
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
Used with LASIK treatment for the correction of myopia and myopic astigmatism.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Contraindications to LASIK.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00365677

Sponsors and Collaborators
Bausch & Lomb Incorporated
Investigators
Study Director: Joanne Egamino, PhD Bausch & Lomb Incorporated
  More Information

No publications provided

Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT00365677     History of Changes
Other Study ID Numbers: 441
Study First Received: June 30, 2006
Last Updated: December 7, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Astigmatism
Myopia
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on May 19, 2013