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
  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
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, see Learn About Clinical Studies.

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 July 23, 2014