LASIK Using the Alcon Allegretto Wavefront-Guided Excimer Laser vs AMO Visx Wavefront-Guided Excimer Laser

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

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-01

Study Completion Date

2012-06-23

Brief Summary

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The purpose of the study is to compare the results of LASIK surgery when using Alcon Allegretto wavefront-guided excimer laser system compared to AMO Visx Custom wavefront-guided excimer laser system in patients with nearsightedness with and without astigmatism.

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Detailed Description

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The patients will have a comprehensive eye examination once they express an interest in the study. This includes a slit lamp examination of the front of the eye and a dilated fundoscopic examination of the back of the eye. if there is any pathology noted that would exclude the patient from the study, then we will inform the patient and make an appropriate referral. If the patient is deemed appropriate for the study after a comprehensive examination included computerized videokeratography, then they can be enrolled. The patient will undergo bilateral simultaneous eye surgery. Which eye is treated with a wavefront-guided excimer laser and which eye is treated with wavefront-optimized will be randomized so there is a 50% chance for either eye to receive one treatment. The patients will be seen on the day of surgery, post op day one, post op day 4-7, one month, three months, six months and one year. The patient will receive topical antibiotics in each eye for one week following the procedure. LASIK treated eyes will receive pred forte 1% ophthalmic drops for one week after treatment. All of this is within the usual and customary standard of care for the treatment of patients undergoing lasik surgery.

The research procedures are the least risky that can be performed consistent with sound research design.

Conditions

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Myopia Astigmatism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Wavefront-guided LASIK - Allegretto

Wavefront-guided LASIK using the Allegretto excimer laser.

Group Type ACTIVE_COMPARATOR

Wavefront-guided LASIK - Allegretto

Intervention Type PROCEDURE

Wavefront-guided LASIK using the Allegretto excimer laser for myopia.

Wavefront-guided LASIK - AMO

Wavefront-guided LASIK using AMO CustomVue excimer laser.

Group Type ACTIVE_COMPARATOR

Wavefront-guided LASIK - AMO

Intervention Type PROCEDURE

Wavefront-guided LASIK using the AMO CustomVue excimer laser for myopia.

Interventions

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Wavefront-guided LASIK - Allegretto

Wavefront-guided LASIK using the Allegretto excimer laser for myopia.

Intervention Type PROCEDURE

Wavefront-guided LASIK - AMO

Wavefront-guided LASIK using the AMO CustomVue excimer laser for myopia.

Intervention Type PROCEDURE

Other Intervention Names

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Alcon Wavelight Allegretto Eye-Q 400 Hz excimer laser AMO Visx CustomVue S4 IR excimer laser

Eligibility Criteria

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Inclusion Criteria

* Subjects age 21 and older with healthy eyes.
* Nearsightedness between -0.50 diopters and -7.00 diopters with or without astigmatism of up to 3.50 diopters.

Exclusion Criteria

* Subjects under the age of 21.
* Patients with excessively thin corneas.
* Patients with topographic evidence of keratoconus.
* Patients with ectatic eye disorders.
* Patients with autoimmune diseases.
* Patients who are pregnant or nursing.
* Patients must have similar levels of nearsightedness with or without astigmatism in each eye.
* They can not be more than 1.5 diopters of difference between eyes.
* Patients must have similar levels of astigmatism in each eye.
* They can not have more than 1.5 diopters of difference in nearsightedness or astigmatism between their two eyes.

Minimum Eligible Age

21 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes