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This will be a prospective, single-center clinical trial of up to 50 eyes of subjects scheduled to undergo LASIK surgery requiring an initial corneal flap. Subjects will be screened for eligibility.
Subjects will undergo LASIK surgery using the LenSx Laser to create the corneal flap prior to excimer laser treatment.
Subjects will be evaluated intraoperatively to assess the ease of lifting the flaps, the stromal bed quality, and the amount of opaque bubble layer. All patients will be followed with routine vision exams for 3 months postoperatively to evaluate changes in visual acuity, manifest refraction, slit lamp examination, and endothelial cell counts.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LASIK Flap Arm | Other | This is a single arm study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LenSx Laser | Device | The LenSx laser system is a femtosecond laser that has received 510(k) clearance for anterior capsulotomy during cataract surgery (K082947), laser phacofragmentation during cataract surgery (K094052) and for use in the creation of a single and multi-plane arc cut/incisions in the cornea (K092647). |
| Measure | Description | Time Frame |
|---|---|---|
| Ease of Lifting Flaps | 0 - Unable to lift flap
| Operative |
| Measure | Description | Time Frame |
|---|---|---|
| Stromal Bed Quality | 0 - very rough 1- moderately rough 2 - rough 3 - smooth 4 - moderately smooth 5 - very smooth (Scale) | Operative |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Ophthalmology, Semmelweis University | Budapest | 1085 | Hungary |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| D006956 | Hyperopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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