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

Phase 4

Completed

• Conditions: Myopia; Astigmatism
• Interventions: Procedure: Wavefront-guided LASIK - Allegretto; Procedure: Wavefront-guided LASIK - AMO

• Registration Number: NCT01454843
• Lead Sponsor: Stanford University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2009-04-01
• Primary Completion: 2011-03-31
• Study First Submitted: 2011-10-06
• Study First Submitted QC: 2011-10-16
• Study First Posted: 2011-10-19
• Study Completion: 2012-06-23
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-03
• Last Update Posted: 2022-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Wavefront-guided LASIK - Allegretto	Wavefront-guided LASIK - Allegretto	Wavefront-guided LASIK using the Allegretto excimer laser.
Wavefront-guided LASIK - AMO	Wavefront-guided LASIK - AMO	Wavefront-guided LASIK using AMO CustomVue excimer laser.

Primary Outcome Measures

Name	Time	Method
Efficacy	1 year	Efficacy measures uncorrected visual acuity following the LASIK surgery. We will record how many eyes see 20/40, 20/30, 20/25, 20/20, 20/16, 20/12.5 and 20/10 after the surgery without glasses or contact lenses. We are measuring how well patients see after the surgery without glasses or contact lenses.

Secondary Outcome Measures

Name	Time	Method
Safety	One year	Will will assess safety by measuring change in best spectacle corrected visual acuity. We will record the number of eyes that gain, lose or have no change in the best spectacle corrected visual acuity after the surgery. This is measured using snellen visual acuity charts. The ideal outcome would be that there were no loss of any lines of best spectacle corrected visual acuity and a high percentage of gains of lines of best spectacle corrected visual acuity.
Predictability	One year	Percentage of eyes within +/- 0.5 diopters of the intended correction
Low contrast visual acuity	1 year	Measuring changes in best spectacle corrected low contrast visual acuity (5 and 25 percent).
Higher order aberrations	1 year	Measure changes in higher order aberrations.

Trial Locations

Locations (1)

Byers Eye Institute at Stanford; 🇺🇸 Palo Alto, California, United States