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| Name | Class |
|---|---|
| Alcon Research | INDUSTRY |
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Comparison of LASIK outcomes using 3 different lasers and a total of 5 different treatment platforms.
This will be a prospective, randomized, multicenter clinical trial in which up to 180 consecutive eyes scheduled to undergo excimer laser in situ keratomileusis (LASIK) for the correction of myopia with or without astigmatism will be enrolled. Enrolled subjects will have a different Excimer laser system performed in each eye. There will be 30 subjects (60 eyes) in each group.
Group 1: WaveLight ALLEGRETTO WAVE™ wavefront guided excimer laser treatment in one eye of the subject and the AMO/VISX CustomVue™ wavefront guided Excimer Laser System performed on the contralateral eye Group 2: WaveLight ALLEGRETTO WAVE™ wavefront guided excimer laser treatment in one eye of the subject and the Bausch and Lomb Zyoptix™ wavefront guided Excimer Laser System performed on the contralateral eye Group 3: WaveLight ALLEGRETTO WAVE™ wavefront optimized excimer laser treatment in one eye of the subject and the Bausch and Lomb Planoscan™ Excimer Laser System performed on the contralateral eye The choice of treatment will first be randomized into one of the three groups and then will also be randomized to the dominant eye prior to LASIK procedure according to the randomization schedule
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Active Comparator | WaveLight ALLEGRETTO WAVE™ wavefront guided excimer laser treatment in one eye of the subject and the AMO/VISX CustomVue™ wavefront guided Excimer Laser System performed on the contralateral eye |
|
| Group 2 | Active Comparator | WaveLight ALLEGRETTO WAVE™ wavefront guided excimer laser treatment in one eye of the subject and the Bausch and Lomb Zyoptix™ wavefront guided Excimer Laser System performed on the contralateral eye |
|
| Group 3 | Active Comparator | WaveLight ALLEGRETTO WAVE™ wavefront optimized excimer laser treatment in one eye of the subject and the Bausch and Lomb Planoscan™ Excimer Laser System performed on the contralateral eye |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Excimer Lasers | Device | WaveLight ALLEGRETTO WAVE™ wavefront guided excimer laser treatment AMO/VISX CustomVue™ wavefront guided Excimer Laser System |
|
| Measure | Description | Time Frame |
|---|---|---|
| Uncorrected visual acuity | 1 month post operative |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lasik Plus-Galleria | Atlanta | Georgia | 30339 | United States | ||
| Lasik Plus Edina |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Feb 23, 2011 | |
| Reset | Mar 17, 2011 | |
| Release | Mar 21, 2011 | |
| Unrelease | Yes | |
| Release | Mar 25, 2011 | |
| Reset | Apr 19, 2011 | |
| Release | Feb 13, 2012 | |
| Unrelease | Yes | |
| Release | Mar 1, 2012 | |
| Reset | Mar 28, 2012 | |
| Release | Apr 5, 2012 | |
| Reset | Apr 30, 2012 | |
| Release | Aug 14, 2012 | |
| Reset | Sep 11, 2012 | |
| Release | Sep 20, 2012 | |
| Reset | Oct 19, 2012 | |
| Release | Dec 7, 2012 | |
| Reset | Jan 11, 2013 | |
| Release | Jan 25, 2013 | |
| Reset | Feb 28, 2013 | |
| Release | Feb 18, 2015 | |
| Reset | Feb 18, 2015 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Feb 23, 2011 | Mar 17, 2011 | |||
| Mar 21, 2011 |
| ID | Term |
|---|---|
| D009216 | Myopia |
| D001251 | Astigmatism |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D054018 | Lasers, Excimer |
| D020731 | Keratomileusis, Laser In Situ |
| ID | Term |
|---|---|
| D007834 | Lasers |
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
| D055618 | Radiation Equipment and Supplies |
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| Excimer Laser for the LASIK procedure | Device | WaveLight ALLEGRETTO WAVE™ wavefront guided excimer laser treatment Bausch and Lomb Zyoptix™ wavefront guided Excimer Laser System |
|
|
| Excimer Laser for LASIK | Device | WaveLight ALLEGRETTO WAVE™ wavefront optimized excimer laser treatment Bausch and Lomb Planoscan™ Excimer Laser System |
|
|
| Edina |
| Minnesota |
| 55435 |
| United States |
| Lasik Plus-Tyson's Corner | McLean | Virginia | 22102 | United States |
| Yes |
| Mar 25, 2011 | Apr 19, 2011 |
| Feb 13, 2012 | Yes |
| Mar 1, 2012 | Mar 28, 2012 |
| Apr 5, 2012 | Apr 30, 2012 |
| Aug 14, 2012 | Sep 11, 2012 |
| Sep 20, 2012 | Oct 19, 2012 |
| Dec 7, 2012 | Jan 11, 2013 |
| Jan 25, 2013 | Feb 28, 2013 |
| Feb 18, 2015 | Feb 18, 2015 |
| D048988 |
| Corneal Surgery, Laser |
| D053685 | Laser Therapy |
| D013812 | Therapeutics |
| D055011 | Ablation Techniques |
| D013514 | Surgical Procedures, Operative |
| D000074431 | Keratectomy |
| D054140 | Refractive Surgical Procedures |
| D013508 | Ophthalmologic Surgical Procedures |