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The purpose of this study is to assess the WaveLight Ultraviolet Femtosecond Laser System, Model 1026 (UV fs-Laser) corneal flap creation accuracy as compared to the already marketed WaveLight FS200 Infrared Femtosecond Laser, Model 1025 (IR fs-Laser).
Subjects who qualify to participate will have both eyes treated in the study (one eye with the UV fs-Laser and the other eye with the IR fs-Laser) and will attend a total of 5 study visits over a period of approximately 2 months. This study will be conducted outside the United States.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| UV fs-Laser | Other | First surgical eye randomly assigned to the UV fs-Laser with the second surgical eye (fellow eye) assigned to the IR fs-Laser for the purpose of corneal flap creation during LASIK surgery |
|
| IR fs-Laser | Other | First surgical eye randomly assigned to the IR fs-Laser with the second surgical eye (fellow eye) assigned to the UV fs-Laser for the purpose of corneal flap creation during LASIK surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| UV fs-Laser | Device | Stationary scanning spot femtosecond laser used for corneal flap creation during refractive surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum deviation of corneal flap thickness at the margins from achieved central flap thickness at 1 month | Corneal flap thickness will be measured using optical coherence tomography (OCT) | Month 1 |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Principal Clinical Trial Lead, CRD Surgical | Alcon Research, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Personaleyes | Sydney | New South Wales | 2000 | Australia |
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| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D020731 | Keratomileusis, Laser In Situ |
| ID | Term |
|---|---|
| D048988 | Corneal Surgery, Laser |
| D053685 | Laser Therapy |
| D013812 | Therapeutics |
| D055011 | Ablation Techniques |
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| IR fs-Laser | Device | Stationary scanning spot femtosecond laser used for corneal flap creation during refractive surgery |
|
|
| LASIK | Procedure | Laser-assisted in situ keratomileusis (LASIK) surgery |
|
| D013514 |
| Surgical Procedures, Operative |
| D000074431 | Keratectomy |
| D054140 | Refractive Surgical Procedures |
| D013508 | Ophthalmologic Surgical Procedures |