Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Alcon Research | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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 .
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Wavelight | Active Comparator | WaveLight ALLEGRETTO WAVE™ wavefront guided or optimized excimer laser treatment |
|
| AMO/VISX CustomVue | Active Comparator | AMO/VISX CustomVue™ |
|
| LADARVision 4000 excimer laser | Active Comparator | LADARVision 4000 excimer laser |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Excimer Laser | Device | WaveLight ALLEGRETTO WAVE™ wavefront guided or optimized excimer laser treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| 1 Day Postoperative Lasik Uncorrected Visual Acuity | 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 Day |
| 1 Week Postoperative Lasik Uncorrected Visual Acuity | 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 week post op |
| 1 Month Postoperative Lasik Visual Acuity | 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 Month Postoperative |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Daniel S. Durrie, MD | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Durrie Vision | Overland Park | Kansas | 66211 | United States | ||
| Karl G. Stonecipher, MD |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Lasik for Treatment of Nearsightedness | WaveLight ALLEGRETTO WAVE™ wavefront guided or optimized excimer laser treatment LADARVision 4000 excimer laser AMO/VISX CustomVue™ excimer laser treatment |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Wavelight | WaveLight ALLEGRETTO WAVE™ wavefront guided or optimized excimer laser treatment |
| BG001 | AMO/VISX CustomVue | AMO/VISX CustomVue™ |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 1 Day Postoperative Lasik Uncorrected Visual Acuity | 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. | Posted | Mean | Standard Deviation | LogMar | 1 Day |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Wavelight | WaveLight ALLEGRETTO WAVE™ wavefront guided or optimized excimer laser treatment |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Brigette Ellis | Durrie Vision | 913-491-3330 | 7255 | bellis@durrievision.com |
Not provided
| ID | Term |
|---|---|
| D009216 | Myopia |
| D001251 | Astigmatism |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D054018 | Lasers, Excimer |
| ID | Term |
|---|---|
| D007834 | Lasers |
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
| D055618 | Radiation Equipment and Supplies |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| AMO/VISX CustomVue™ | Device | Excimer Laser |
|
| LADARVision 4000 excimer laser | Device | Excimer Laser |
|
| Greensboro |
| North Carolina |
| 27410 |
| United States |
| BG002 | LADARVision 4000 Excimer Laser | LADARVision 4000 excimer laser treatment |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| LADARVision 4000 Excimer Laser |
LADARVision 4000 excimer laser treatment |
|
|
| Primary | 1 Week Postoperative Lasik Uncorrected Visual Acuity | 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. | Posted | Mean | Standard Deviation | LogMar | 1 week post op |
|
|
|
| Primary | 1 Month Postoperative Lasik Visual Acuity | 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. | Posted | Mean | Standard Deviation | LogMar | 1 Month Postoperative |
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | AMO/VISX CustomVue | AMO/VISX CustomVue™ | 0 | 10 | 0 | 10 |
| EG002 | LADARVision 4000 Excimer Laser | LADARVision 4000 excimer laser treatment | 0 | 10 | 0 | 10 |
Not provided
Not provided