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| Name | Class |
|---|---|
| Alcon Research | INDUSTRY |
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The purpose of this study is to document the programmed flap thickness to achieved flap thickness using the FS200 femtosecond laser in performing LASIK procedure. The FS200 Femtosecond laser is a precision surgical device that is used to create a flap in a FDA approved LASIK procedure.
The objective of this study is to evaluate the thickness of the corneal flap created with the FS 200 Femtosecond laser flap during the LASIK procedure using the Visante and OptiVue OCT ultrasound devices.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FS200 Femtosecond Laser | Other | The LASIK flap will be created using the FS200 Femtosecond Laser |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FS200 Femtosecond Laser | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Flap Thickness | The flap thickness will be measured one week postoperative using the Visante OCT and the Optivue OCT devices | 1 Week Postoperative visit |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Uncorrected Visual Acuity at 1 Day, 1 Week, and 1 Month Postoperatively | Change in Uncorrected visual acuity will be measured at 1 Day, 1 week, and 1 month postoperatively | Postoperatively 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Satisfaction Survey over Time | Subject questionnaire will be administered to evaluate overall patient satisfaction postoperatively | Postoperatively Day 1, Week 1, Month 1 |
INCLUSION CRITERIA
The following are requirements for a potential study patient's inclusion into the study:
EXCLUSION CRITERIA
The following are exclusion criteria for study patients in this study:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel S. Durrie, MD | Durrie Vision | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Durrie Vision | Overland Park | Kansas | 66211 | United States |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Feb 19, 2015 | |
| Reset | Mar 4, 2015 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Feb 19, 2015 | Mar 4, 2015 |
| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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