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

October 6, 2011
March 9, 2014
June 2011
June 2014   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01454843 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
LASIK Using the Alcon Allegretto Wavefront-Guided Excimer Laser vs AMO Visx Wavefront-Guided Excimer Laser
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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Myopia
  • Astigmatism
  • 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
  • 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
  • Active Comparator: Wavefront-guided LASIK - Allegretto
    Wavefront-guided LASIK using the Allegretto excimer laser.
    Intervention: Procedure: Wavefront-guided LASIK - Allegretto
  • Active Comparator: Wavefront-guided LASIK - AMO
    Wavefront-guided LASIK using AMO CustomVue excimer laser.
    Intervention: Procedure: Wavefront-guided LASIK - AMO
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
60
June 2014
June 2014   (final data collection date for primary outcome measure)

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.
Both
21 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01454843
21220
No
Edward E. Manche, Stanford University
Stanford University
Not Provided
Principal Investigator: Edward E Manche, MD Stanford University
Stanford University
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP