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| Name | Class |
|---|---|
| Alcon Research | INDUSTRY |
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This study evaluates differences in postoperative visual outcomes between patients receiving Topography-Guided LASIK in one eye and Small Incision Lenticule Extraction in the other eye.
This is a prospective, randomized, simultaneous, contralateral eye study including at least 42 patients undergoing refractive correction surgery. Patients will be selected from the Hoopes Vision patient population after a preliminary refractive evaluation has been completed. Patients who express an interest in the study will be consented. After informed consent has been obtained and the patient has completed a screening exam and met all study criteria they will be considered enrolled. Randomization will ensure 50% of Right Eyes will receive Topography-Guided LASIK and 50% of Right Eyes will receive Small Incision Lenticule Extraction. Subjects will be given postoperative care instructions and medications following standard of care practices. Subjects will return for a 1-day, 1-week, 1-month, 3-month, and 12-month visit. Retreatments may only occur after all postoperative study visits have been completed and/or the subject has exited the study. At the preliminary screening visit, 1-month, 3-month, and 12-mont postoperative visits, patients will complete a Patient Participant Questionnaire.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Topography-Guided LASIK | Active Comparator | Subjects receive Topography-Guided LASIK surgery on one eye. |
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| Small Incision Lenticule Extraction | Active Comparator | Subjects receive Small Incision Lenticule Extraction surgery on one eye. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Topography Guided LASIK Surgery | Device | LASIK surgery, using corneal topography data in treatment profile, to correct myopia or myopia with astigmatism refractive error. |
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| Measure | Description | Time Frame |
|---|---|---|
| Uncorrected Visual Acuity | Percentage of eyes with Uncorrected Visual Acuity of 20/20 or better | 12 months |
| Corrected Visual Acuity | Percentage of eyes with Corrected Visual Acuity of 20/20 or better | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Predictability of Intended Outcome | Percentage of eyes with refractive error within +/- 0.50 D MRSE and +/- 1.00 D MRSE of intended correction | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Majid Moshirfar, MD | Hoopes Vision | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hoopes Vision | Draper | Utah | 84020 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38951314 | Derived | Moin KA, Manion GN, Pandiri S, Hoopes PC, Moshirfar M. Three-Month Comprehensive Outcomes of Topography-Guided LASIK Versus Keratorefractive Lenticule Extraction (KLEx): A Prospective Contralateral Study. Ophthalmol Ther. 2024 Aug;13(8):2265-2284. doi: 10.1007/s40123-024-00987-y. Epub 2024 Jul 1. |
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No individual participant data will be shared with other researchers outside of those participating in this specific study.
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| ID | Term |
|---|---|
| D009216 | Myopia |
| D001251 | Astigmatism |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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Contralateral Eye to Eye Comparison
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| Small Incision Lenticule Extraction Surgery | Device | Corneal lenticule formation using a femtosecond laser, with subsequent lenticule extraction, to correct myopia or myopia with astigmatism refractive error. |
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