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The objective of this study was to compare the safety and effectiveness of two versions of the Bausch & Lomb Zyoptix Tissue Saving Aspheric Algorithm versus the current Zyoptix Tissue Saving Algorithm when used for myopia and myopic astigmatism LASIK treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Zyoptix Tissue Saving Aspheric | Experimental | The Bausch & Lomb Zyoptix Tissue Saving Aspheric algorithm is used for treatment with LASIK for the correction of myopia and myopic astigmatism. |
|
| Zyoptix Tissue Saving | Active Comparator | The Bausch & Lomb Zyoptix Tissue Saving algorithm is used for treatment with LASIK for the correction of myopia and myopic astigmatism. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The Bausch & Lomb Zyoptix Tissue Saving Aspheric algorithm | Device | Used with LASIK treatment for the correction of myopia and myopic astigmatism. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Uncorrected visual acuity | At 90 days post surgery | |
| Preservation of best spectacle corrected high contrast logMAR distance visual acuity compared to baseline. | At 90 days post surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Deviation from target correction | At 90 days post surgery | |
| Improvement in uncorrected distance high contrast logMAR visual acuity compared to baseline | At 90 days post surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joanne Egamino, PhD | Bausch & Lomb Incorporated | Study Director |
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| The Bausch & Lomb Zyoptix Tissue Saving algorithm | Device | Used with LASIK treatment for the correction of myopia and myopic astigmatism. |
|
| ID | Term |
|---|---|
| D009216 | Myopia |
| D001251 | Astigmatism |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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