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Completed

NCT Number: NCT01454843

LASIK Using the Alcon Allegretto Wavefront-Guided Excimer Laser vs 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.

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Key information

Conditions

Myopia Astigmatism Eye Diseases Refractive Errors

Age range

21 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Byers Eye Institute at Stanford

Palo Alto, California, 94303, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Wavefront-guided LASIK - Allegretto

Procedure

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

Other names: Alcon Wavelight Allegretto Eye-Q 400 Hz excimer laser

Wavefront-guided LASIK - AMO

Procedure

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

Other names: AMO Visx CustomVue S4 IR excimer laser

Primary outcomes

  1. 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.

Secondary outcomes

  1. Low contrast visual acuity

    Time frame: 1 year

    Measuring changes in best spectacle corrected low contrast visual acuity (5 and 25 percent).

  2. Higher order aberrations

    Time frame: 1 year

    Measure changes in higher order aberrations.

  3. 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.

  4. Predictability

    Time frame: One year

    Percentage of eyes within +/- 0.5 diopters of the intended correction

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

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

Acronym: LASIK

Important dates

Study start
2009
Primary completion
2011
Study completion
2012
First posted
Oct 19, 2011
Registry last updated
Apr 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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