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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Edward E. Manche, Stanford University
ClinicalTrials.gov Identifier:
NCT01454843
First received: October 6, 2011
Last updated: March 9, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Myopia
Astigmatism
Procedure: Wavefront-guided LASIK - Allegretto
Procedure: Wavefront-guided LASIK - AMO
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective Eye to Eye Comparison of LASIK Using the Alcon Allegretto Wavefront-Guided Excimer Laser Versus AMO Visx Wavefront-Guided Excimer Laser

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Efficacy [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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:
  • Low contrast visual acuity [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Measuring changes in best spectacle corrected low contrast visual acuity (5 and 25 percent).

  • Higher order aberrations [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Measure changes in higher order aberrations.

  • Safety [ Time Frame: One year ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: One year ] [ Designated as safety issue: No ]
    Percentage of eyes within +/- 0.5 diopters of the intended correction


Estimated Enrollment: 60
Study Start Date: June 2011
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: AMO Visx CustomVue S4 IR excimer laser

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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01454843

Locations
United States, California
Byers Eye Institute at Stanford
Palo Alto, California, United States, 94303
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Edward E Manche, MD Stanford University
  More Information

No publications provided

Responsible Party: Edward E. Manche, Professor of Ophthalmology, Stanford University
ClinicalTrials.gov Identifier: NCT01454843     History of Changes
Other Study ID Numbers: 21220
Study First Received: October 6, 2011
Last Updated: March 9, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Stanford University:
Myopia
Astigmatism
Aberrations
Wavefront
LASIK
Wavefront LASIK

Additional relevant MeSH terms:
Astigmatism
Myopia
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on April 15, 2014