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

NCT ID: NCT00365677

Last Updated: 2011-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

127 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-10-31

Study Completion Date

2006-03-31

Brief Summary

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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

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Conditions

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Myopia Astigmatism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

The Bausch & Lomb Zyoptix Tissue Saving Aspheric algorithm

Intervention Type DEVICE

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

Zyoptix Tissue Saving

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

Group Type ACTIVE_COMPARATOR

The Bausch & Lomb Zyoptix Tissue Saving algorithm

Intervention Type DEVICE

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

Interventions

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The Bausch & Lomb Zyoptix Tissue Saving Aspheric algorithm

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

Intervention Type DEVICE

The Bausch & Lomb Zyoptix Tissue Saving algorithm

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Contraindications to LASIK.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Bausch & Lomb Incorporated

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Joanne Egamino, PhD

Role: STUDY_DIRECTOR

Bausch & Lomb Incorporated

Other Identifiers

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441

Identifier Type: -

Identifier Source: org_study_id