Accuracy of LASIK Flaps Created With the LenSx® Femtosecond Laser

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-28

Study Completion Date

2016-04-09

Brief Summary

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The purpose of this study is to evaluate the thickness accuracy of Laser-assisted in situ keratomileusis (LASIK) flaps created with the LenSx® Laser.

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Detailed Description

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Conditions

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Myopia Hyperopia

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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LenSx

LASIK surgery in both eyes using LenSx® Femtosecond Laser System

Group Type EXPERIMENTAL

Femtosecond Laser System

Intervention Type DEVICE

Used for the creation of a corneal flap in patients undergoing LASIK surgery

LASIK surgery

Intervention Type PROCEDURE

Interventions

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Femtosecond Laser System

Used for the creation of a corneal flap in patients undergoing LASIK surgery

Intervention Type DEVICE

LASIK surgery

Intervention Type PROCEDURE

Other Intervention Names

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LenSx®

Eligibility Criteria

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Inclusion Criteria

* Diagnosed with myopia or hyperopia and eligible for femtosecond laser initiated LASIK surgery;
* Best corrected visual acuity (BCVA) correctable to at least 20/25 in each eye;
* If contact lens wearer, willing to discontinue contact lens wear prior to screening procedures;
* Willing and able to return for ALL scheduled follow-up examinations;
* Willing and able to provide written informed consent;
* Eligible for bilateral LASIK procedures to be done on the same day;

Exclusion Criteria

* Previous corneal surgery, corneal lesions that will impede laser treatment, corneal edema, hypotony, glaucoma, existing corneal implant, or keratoconus;
* Known sensitivity to planned study concomitant medications;
* Participation in any other ophthalmic drug or device clinical study for 30 days prior to or during the time of participation in this study;
* Irregular astigmatism, based on the Investigator's judgement;
* Pregnant, lactating or planning to become pregnant during the course of the study;

Minimum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No