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

Bausch + Lomb

Status: Completed

Conditions: Myopia; Astigmatism

Treatments: Device: The Bausch & Lomb Zyoptix Tissue Saving Aspheric algorithm; Device: The Bausch & Lomb Zyoptix Tissue Saving algorithm

Study type: Interventional

Funder types: Industry

Identifiers

NCT00365677

441

Details and patient eligibility

About

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.

Enrollment: 127 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Myopia with or without astigmatism.
• Normal Corneal topography
• Willing to have both eyes treated with the laser.

Exclusion criteria

• Contraindications to LASIK.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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127 participants in 2 patient groups

Zyoptix Tissue Saving Aspheric

Experimental group

Description:

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

Treatment:

Device: The Bausch & Lomb Zyoptix Tissue Saving Aspheric algorithm

Zyoptix Tissue Saving

Active Comparator group

Description:

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

Treatment:

Device: The Bausch & Lomb Zyoptix Tissue Saving algorithm