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Contralateral Comparison of Three Excimer Laser Systems in Performing LASIK (WLCVLV-001)

This study has been completed.
Sponsor:
Collaborator:
Alcon Laboratories
Information provided by (Responsible Party):
Daniel S. Durrie, MD, Durrie Vision
ClinicalTrials.gov Identifier:
NCT00821236
First received: January 9, 2009
Last updated: January 25, 2013
Last verified: January 2013
  Purpose

The purpose of this study is to compare LASIK outcomes using the WaveLight ALLEGRETTO WAVE™ wavefront guided or optimized excimer laser treatment with the AMO/VISX CustomVue™ and the LADARVision 4000 excimer laser treatment.

Standard refractive outcomes such as uncorrected and best corrected visual acuity, and intended vs. achieved postoperative refractions will be evaluated; in addition, high order optical aberrations, contrast sensitivity, and topography will be measured.


Condition Intervention Phase
Myopia
Astigmatism
Device: Excimer Laser
Device: AMO/VISX CustomVue™
Device: LADARVision 4000 excimer laser
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective, Multi Center Clinical Comparison of Fellow Eyes Undergoing Lasik Using the Wavelight Allegretto Wave™ Excimer Laser in One Eye and the Amo/Visx Customvue™ or the Ladarvision 4000 Excimer Laser System in the Contralateral Eye

Further study details as provided by Durrie Vision:

Primary Outcome Measures:
  • 1 Day Postoperative Lasik Uncorrected Visual Acuity [ Time Frame: 1 Day ] [ Designated as safety issue: No ]
    Visual acuity measured without glasses or contact lenses. LogMar is a method of measuring visual acuity. Generally speaking, the U.S. population is familiar with 20/20 visual acuity reference. Samples of LogMar equivalent values would be 20/20=0.0 LogMar, 20/25=0.1 LogMar, 20/16=-0.1, etc.

  • 1 Week Postoperative Lasik Uncorrected Visual Acuity [ Time Frame: 1 week post op ] [ Designated as safety issue: No ]
    Visual acuity measured withouth glasses or contact lenses. LogMar is a method of measuring visual acuity. Generally speaking, the U.S. population is familiar with 20/20 visual acuity reference. Samples of LogMar equivalent values would be 20/20=0.0 LogMar, 20/25=0.1 LogMar, 20/16=-0.1, etc.

  • 1 Month Postoperative Lasik Visual Acuity [ Time Frame: 1 Month Postoperative ] [ Designated as safety issue: No ]
    Visual acuity measured without glasses or contact lenses. LogMar is a method of measuring visual acuity. Generally speaking, the U.S. population is familiar with 20/20 visual acuity reference. Samples of LogMar equivalent values would be 20/20=0.0 LogMar, 20/25=0.1 LogMar, 20/16=-0.1, etc.


Enrollment: 40
Study Start Date: January 2009
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Wavelight
WaveLight ALLEGRETTO WAVE™ wavefront guided or optimized excimer laser treatment
Device: Excimer Laser
WaveLight ALLEGRETTO WAVE™ wavefront guided or optimized excimer laser treatment
Active Comparator: AMO/VISX CustomVue
AMO/VISX CustomVue™
Device: AMO/VISX CustomVue™
Excimer Laser
Active Comparator: LADARVision 4000 excimer laser
LADARVision 4000 excimer laser
Device: LADARVision 4000 excimer laser
Excimer Laser

Detailed Description:

The primary objective of this study is to compare WaveLight ALLEGRETTO WAVE™ wavefront guided or optimized excimer laser treatment with the AMO/VISX CustomVue™ and the LADARVision 4000 excimer laser treatment using both subjective and objective outcome measures. This comparison will be made between fellow eyes of the same patient following excimer laser ablation using the WaveLight ALLEGRETTO WAVE™ Excimer Laser System in one eye and the AMO/VISX CustomVue™ or the LADARVision 4000 excimer laser in the contralateral eye .

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects who have up to -7.00D of spherical equivalent myopia or myopia with astigmatism, with up to -7.00D of spherical component and up to 3.00 D of astigmatic component at the spectacle plane in both eyes.
  • Subjects must have a stable refraction as documented by previous clinical records. Spherical equivalent has not progressed at a rate of more than 0.50D per year prior to the baseline examination in both eyes or as documented by clinical judgment by the investigator.
  • Subjects who wear contact lenses must discontinue wear at least 3 days for soft and at least 3 weeks for RGP prior to the preoperative evaluation or surgery, in either eye.
  • Subjects must have visual acuity correctable to at least 20/20 in both eyes.
  • Subjects must be at least 18 years of age.
  • Subjects must be willing and able to return for scheduled follow up examinations for twelve months after LASIK surgery.
  • Subjects must sign and be given a copy of the written Informed Consent form.

Exclusion Criteria:

  • Subjects for whom both eyes do not meet all inclusion criteria and either eye meets any exclusion criteria.
  • Subjects for whom the combination of their baseline corneal thickness and the planned operative parameters for the LASIK procedure would result in less than 250 microns of remaining posterior corneal thickness below the flap postoperatively in either eye.
  • Eyes for which the baseline standard manifest refraction exhibits greater than 1.00D more minus in sphere power, or a difference of greater than 0.75 D in cylinder power.
  • Subjects desiring spherical under correction in one eye (i.e. no monovision correction is permitted).
  • Subjects for whom the preoperative assessment of the ocular topography and /or aberrations indicates that either eye is not a suitable candidate for LASIK vision correction procedure. Examples include frank or forme frust keratoconus, corneal warpage, pellucid marginal degeneration, etc.
  • Subjects with clinically significant dry eye syndrome or clinically significant blepharitis in either eye.
  • Subjects with anterior segment pathology, including clinically significant cataracts or corneal scarring or neovascularization in either eye.
  • Subjects with residual, recurrent, active ocular or eyelid disease, including any corneal abnormality (specifically, recurrent corneal erosion, severe basement membrane disease) in either eye.
  • Subjects with ophthalmoscopic signs of progressive or unstable myopia or keratoconus (or keratoconus suspect) in either eye.
  • Subjects with unstable (distorted/not clear) corneal mires on central keratometry in either eye.
  • Subjects who have undergone previous intraocular or corneal surgery of any kind, including any type of surgery for either refractive or therapeutic purposes in either eye.
  • Subjects who have a history of Herpes zoster or Herpes simplex keratitis.
  • Subjects on chronic systemic corticosteroid or other immunosuppressive therapy that may affect wound healing, any immunocompromised subjects, and subjects with clinically significant atopic disease, connective tissue disease, or diabetes.
  • Subjects with a history of steroid-responsive rise in intraocular pressure, glaucoma, or preoperative Intraocular pressure>23 mm Hg in either eye.
  • Subjects with macular pathology in either eye.
  • Subjects who are pregnant, lactating, or planning to be pregnant during the course of the study.
  • Subjects with known sensitivity to planned study concomitant medications.
  • Subjects participating in any other ophthalmic drug or device clinical trial during the time of this clinical investigation.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00821236

Locations
United States, Kansas
Durrie Vision
Overland Park, Kansas, United States, 66211
United States, North Carolina
Karl G. Stonecipher, MD
Greensboro, North Carolina, United States, 27410
Sponsors and Collaborators
Durrie Vision
Alcon Laboratories
Investigators
Principal Investigator: Daniel S. Durrie, MD
  More Information

No publications provided

Responsible Party: Daniel S. Durrie, MD, President, Durrie Vision
ClinicalTrials.gov Identifier: NCT00821236     History of Changes
Other Study ID Numbers: WLCVLV-001
Study First Received: January 9, 2009
Results First Received: March 24, 2011
Last Updated: January 25, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Durrie Vision:
Myopia
LASIK
Astigmatism
Laser Vision Correction
Excimer Laser

Additional relevant MeSH terms:
Astigmatism
Eye Diseases
Refractive Errors

ClinicalTrials.gov processed this record on November 20, 2014