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

Myopia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00365677
• Other study ID #: 441
• Status: Completed
• Phase: N/A
• First received: June 30, 2006
• Last updated: December 7, 2011
• Start date: October 2005
• Est. completion date: March 2006

Study information

• Verified date: December 2011
• Source: Bausch & Lomb Incorporated
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 127
• Est. completion date: March 2006
• Est. primary completion date: March 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Myopia with or without astigmatism.

• Normal Corneal topography

• Willing to have both eyes treated with the laser.

Exclusion Criteria:

• Contraindications to LASIK.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Astigmatism
• Myopia

Intervention

Device:
• The Bausch & Lomb Zyoptix Tissue Saving Aspheric algorithm
Used with LASIK treatment for the correction of myopia and myopic astigmatism.
• The Bausch & Lomb Zyoptix Tissue Saving algorithm
Used with LASIK treatment for the correction of myopia and myopic astigmatism.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bausch & Lomb Incorporated

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Uncorrected visual acuity		At 90 days post surgery	No
Primary	Preservation of best spectacle corrected high contrast logMAR distance visual acuity compared to baseline.		At 90 days post surgery	No
Secondary	Deviation from target correction		At 90 days post surgery	No
Secondary	Improvement in uncorrected distance high contrast logMAR visual acuity compared to baseline		At 90 days post surgery	No