A Study to Evaluate the Safety and Effectiveness of the Technols 217z Zyoptix System for Hyperopia

NCT ID: NCT00348205

Last Updated: 2020-09-14

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-06-30

Study Completion Date

2009-03-31

Brief Summary

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A study to demonstrate the safety and effectiveness of wavefront laser refractive surgery treatments for hyperopia and astigmatism.

Detailed Description

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Conditions

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Hyperopia Astigmatism

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Technolas 217z Zyoptix System

Bausch \& Lomb Technolas 217z Zyoptix System with Treatment Planner Customized Treatment Calculation Software.

Group Type EXPERIMENTAL

Technolas 217z Zyoptix Laser

Intervention Type DEVICE

Technolas 217z Zyoptix System with Treatment Planner Customized Treatment Calculation Software for the wavefront-guided LASIK treatment of hyperopia and hyperoptic astigmatism.

Interventions

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Technolas 217z Zyoptix Laser

Technolas 217z Zyoptix System with Treatment Planner Customized Treatment Calculation Software for the wavefront-guided LASIK treatment of hyperopia and hyperoptic astigmatism.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Hyperopia with or without astigmatism.

Exclusion Criteria

* Contraindications to LASIK.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bausch & Lomb Incorporated

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Bausch & Lomb

Rochester, New York, United States

Site Status

Countries

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United States

Other Identifiers

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369

Identifier Type: -

Identifier Source: org_study_id

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