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Sponsors and Collaborators: |
Durrie Vision Alcon Laboratories |
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Information provided by: | Durrie Vision |
ClinicalTrials.gov Identifier: | NCT00821236 |
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 |
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Myopia Astigmatism |
Device: Excimer Laser Device: AMO/VISX CustomVue™ Device: LADARVision 4000 excimer laser |
Phase IV |
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 |
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 |
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Wavelight: Active Comparator
WaveLight ALLEGRETTO WAVE™ wavefront guided or optimized excimer laser treatment
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Device: Excimer Laser
WaveLight ALLEGRETTO WAVE™ wavefront guided or optimized excimer laser treatment
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AMO/VISX CustomVue: Active Comparator
AMO/VISX CustomVue™
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Device: AMO/VISX CustomVue™
Excimer Laser
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LADARVision 4000 excimer laser: Active Comparator
LADARVision 4000 excimer laser
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Device: LADARVision 4000 excimer laser
Excimer Laser
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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 .
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
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 |
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 |
Myopia LASIK Astigmatism Laser Vision Correction Excimer Laser |
Eye Diseases Myopia Refractive Errors Astigmatism |
Eye Diseases Myopia Refractive Errors Astigmatism |