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

April 3, 2022 updated by: Edward E. Manche, Stanford University

A Prospective Eye to Eye Comparison of LASIK Using the Alcon Allegretto Wavefront-Guided Excimer Laser Versus AMO Visx Wavefront-Guided Excimer Laser

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Palo Alto, California, United States, 94303
        • Byers Eye Institute at Stanford

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 60 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Wavefront-guided LASIK - Allegretto
Wavefront-guided LASIK using the Allegretto excimer laser.
Procedure: Wavefront-guided LASIK - Allegretto
Wavefront-guided LASIK using the Allegretto excimer laser for myopia.
Other Names:
  • Alcon Wavelight Allegretto Eye-Q 400 Hz excimer laser
ACTIVE_COMPARATOR: Wavefront-guided LASIK - AMO
Wavefront-guided LASIK using AMO CustomVue excimer laser.
Procedure: Wavefront-guided LASIK - AMO
Wavefront-guided LASIK using the AMO CustomVue excimer laser for myopia.
Other Names:
  • AMO Visx CustomVue S4 IR excimer laser

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy
Time Frame: 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.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Low contrast visual acuity
Time Frame: 1 year
Measuring changes in best spectacle corrected low contrast visual acuity (5 and 25 percent).
1 year
Higher order aberrations
Time Frame: 1 year
Measure changes in higher order aberrations.
1 year
Safety
Time Frame: 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.
One year
Predictability
Time Frame: One year
Percentage of eyes within +/- 0.5 diopters of the intended correction
One year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 1, 2009

Primary Completion (ACTUAL)

March 31, 2011

Study Completion (ACTUAL)

June 23, 2012

Study Registration Dates

First Submitted

October 6, 2011

First Submitted That Met QC Criteria

October 16, 2011

First Posted (ESTIMATE)

October 19, 2011

Study Record Updates

Last Update Posted (ACTUAL)

April 11, 2022

Last Update Submitted That Met QC Criteria

April 3, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21220

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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