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

Bausch & Lomb Incorporated127 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

127

Conditions

Myopia Astigmatism

Interventions

The Bausch & Lomb Zyoptix Tissue Saving Aspheric algorithmDEVICE

Used with LASIK treatment for the correction of myopia and myopic astigmatism.

The Bausch & Lomb Zyoptix Tissue Saving algorithmDEVICE

Used with LASIK treatment for the correction of myopia and myopic astigmatism.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Myopia with or without astigmatism. * Normal Corneal topography * Willing to have both eyes treated with the laser. Exclusion Criteria: * Contraindications to LASIK.

Outcomes

Primary Outcomes

Uncorrected visual acuity

Time frame: At 90 days post surgery

Preservation of best spectacle corrected high contrast logMAR distance visual acuity compared to baseline.

Time frame: At 90 days post surgery

Secondary Outcomes

Deviation from target correction

Time frame: At 90 days post surgery

Improvement in uncorrected distance high contrast logMAR visual acuity compared to baseline

Time frame: At 90 days post surgery

Data from ClinicalTrials.gov

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