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

• Sponsor: Bausch & Lomb Incorporated (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00365677
• Collaborator: (none)
• Enrollment: 127
• Arms: 2
• Duration (Months): 5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Myopia; Astigmatism	Device: The Bausch & Lomb Zyoptix Tissue Saving Aspheric algorithm; Device: The Bausch & Lomb Zyoptix Tissue Saving algorithm	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 127 participants
• 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
• Study Start Date: Oct 1, 2005
• Actual Primary Completion Date: Mar 1, 2006
• Actual Study Completion Date: Mar 1, 2006

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

1. Uncorrected visual acuity [At 90 days post surgery]

2. Preservation of best spectacle corrected high contrast logMAR distance visual acuity compared to baseline. [At 90 days post surgery]

Secondary Outcome Measures

1. Deviation from target correction [At 90 days post surgery]

2. Improvement in uncorrected distance high contrast logMAR visual acuity compared to baseline [At 90 days post surgery]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

No locations specified.

Sponsors and Collaborators

• Bausch & Lomb Incorporated

Investigators

• Study Director: Joanne Egamino, PhD, Bausch & Lomb Incorporated

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Bausch & Lomb Incorporated
• ClinicalTrials.gov Identifier: NCT00365677
• Other Study ID Numbers: 441
• First Posted: Aug 17, 2006
• Last Update Posted: Dec 8, 2011
• Last Verified: Dec 1, 2011

• Additional relevant MeSH terms: Myopia; Astigmatism

Study Results

No Results Posted as of Dec 8, 2011