WaveLight® Refractive Myopic Study

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2014-08-31

Brief Summary

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The purpose of this study is to evaluate outcomes of subjects undergoing myopic surgery using the WaveLight® Refractive Suite (Excimer EX500 and Femtosecond FS200 lasers).

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Detailed Description

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Conditions

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Refractive Error

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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WaveLight Refractive Suite

LASIK surgery (laser in situ keratomileusis) per standard of care

Group Type EXPERIMENTAL

Wavelight® Refractive Suite

Intervention Type DEVICE

Excimer EX500 and Femtosecond FS200 lasers (Wavelight® Refractive Suite) used during LASIK surgery for corneal flap creation and corneal ablation

LASIK surgery

Intervention Type PROCEDURE

Surgical procedure for treating refractive error based on corneal reshaping

Interventions

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Wavelight® Refractive Suite

Excimer EX500 and Femtosecond FS200 lasers (Wavelight® Refractive Suite) used during LASIK surgery for corneal flap creation and corneal ablation

Intervention Type DEVICE

LASIK surgery

Surgical procedure for treating refractive error based on corneal reshaping

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Willing and able to understand and sign an informed consent form.
* Have refractive error (in both eyes) that requires refractive surgery.
* Willing to undergo LASIK surgery using the Wavelight® Refractive Suite.
* Myopia between 0.00 to -12.0 diopters pre-operatively.
* Astigmatism between 0.00 to +6.00 diopters pre-operatively.
* Willing and able to attend post-operative examinations per protocol schedule.

Exclusion Criteria

* Participation in a clinical study within the last 30 days.
* History of previous corneal surgery in either eye.
* Multifocal ablations in either eye.
* PRK or PTK surgery in either eye.
* Suffering from acute or recurring eye diseases in either eye, such as corneal ulcers, cataract, etc.
* Any ocular disease and/or condition that, in the Investigator's clinical judgment, may put subject at significant risk, compromise study results, or interfere significantly with subject's participation in the study.
* Unable to discontinue contact lens wear as specified in protocol.
* History of Herpes simplex or Herpes zoster keratitis.
* Active ocular rosacea.
* Lyme disease.
* History of dry eye that is unresponsive to treatment.
* Severe ocular allergies.
* Other medical conditions and use of medications as specified in protocol.
* Pregnant or planning to become pregnant during the study.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No