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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:
ClinicalTrials.gov Identifier:
NCT00365677
First Posted: August 17, 2006
Last Update Posted: December 8, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Bausch & Lomb Incorporated
  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
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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 ]
  • Preservation of best spectacle corrected high contrast logMAR distance visual acuity compared to baseline. [ Time Frame: At 90 days post surgery ]

Secondary Outcome Measures:
  • Deviation from target correction [ Time Frame: At 90 days post surgery ]
  • Improvement in uncorrected distance high contrast logMAR visual acuity compared to baseline [ Time Frame: At 90 days post surgery ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00365677


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

Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT00365677     History of Changes
Other Study ID Numbers: 441
First Submitted: June 30, 2006
First Posted: August 17, 2006
Last Update Posted: December 8, 2011
Last Verified: December 2011

Additional relevant MeSH terms:
Myopia
Astigmatism
Refractive Errors
Eye Diseases