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A Prospective, Randomized, 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 (Wlcvlv-001) (WLCVLV-001)
This study is currently recruiting participants.
Verified by Durrie Vision, January 2009
First Received: January 9, 2009   Last Updated: January 12, 2009   History of Changes
Sponsors and Collaborators: Durrie Vision
Alcon Laboratories
Information provided by: Durrie Vision
ClinicalTrials.gov Identifier: NCT00821236
  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 IV

U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Efficacy Study
Official Title: A Prospective, Randomized, 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:
  • Standard refractive outcomes such as uncorrected and best corrected visual acuity, and intended vs. achieved postoperative refractions will be evaluated [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • high order optical aberrations, contrast sensitivity, and topography will be measured. [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: January 2009
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Wavelight: Active Comparator
WaveLight ALLEGRETTO WAVE™ wavefront guided or optimized excimer laser treatment
Device: Excimer Laser
WaveLight ALLEGRETTO WAVE™ wavefront guided or optimized excimer laser treatment
AMO/VISX CustomVue: Active Comparator
AMO/VISX CustomVue™
Device: AMO/VISX CustomVue™
Excimer Laser
LADARVision 4000 excimer laser: Active Comparator
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 IOP>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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00821236

Locations
United States, Kansas
Durrie Vision Recruiting
Overland Park, Kansas, United States, 66211
Contact: Brigette L Ellis, BSE     913-491-3330 ext 7255     bellis@durrievision.com    
Contact: Christy Harrison     913-491-3330 ext 7232     charrison@durrievision.com    
Principal Investigator: Daniel S Durrie, MD            
Sub-Investigator: Jason E Stahl, MD            
Sub-Investigator: Marla G Kennard, OD            
United States, North Carolina
Karl G. Stonecipher, MD Not yet recruiting
Greensboro, North Carolina, United States, 27410
Principal Investigator: Karl G. Stonecipher, MD            
Sub-Investigator: Neil McMackin, OD            
Sponsors and Collaborators
Durrie Vision
Alcon Laboratories
  More Information

No publications provided

Responsible Party: Durrie Vision ( Daniel S. Durrie, MD )
Study ID Numbers: WLCVLV-001
Study First Received: January 9, 2009
Last Updated: January 12, 2009
ClinicalTrials.gov Identifier: NCT00821236     History of Changes
Health Authority: United States: Food and Drug Administration

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

Study placed in the following topic categories:
Eye Diseases
Myopia
Refractive Errors
Astigmatism

Additional relevant MeSH terms:
Eye Diseases
Myopia
Refractive Errors
Astigmatism

ClinicalTrials.gov processed this record on May 06, 2009