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

Not Applicable

Completed

• Conditions: Myopia; Astigmatism
• Interventions: Device: The Bausch & Lomb Zyoptix Tissue Saving Aspheric algorithm; Device: The Bausch & Lomb Zyoptix Tissue Saving algorithm

• Registration Number: NCT00365677
• Lead Sponsor: Bausch & Lomb Incorporated

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-10
• Primary Completion: 2006-03
• Study Completion: 2006-03
• Study First Submitted: 2006-06-30
• Study First Submitted QC: 2006-08-15
• Study First Posted: 2006-08-17
• Status Verified: 2011-12
• Last Update Submitted: 2011-12-07
• Last Update Posted: 2011-12-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 127

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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