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The purpose of this study is to see how safe the WaveLight Ultraviolet Femtosecond Laser, Model 1026 (UV fs-Laser), is for creating corneal flaps during laser-assisted in situ keratomileusis (LASIK) surgery. This study will be conducted in Australia.
Subjects who qualify to participate will have both eyes treated. Each subject will be randomly assigned to 1 of 2 topical anesthetics (numbing eye drops) and each eye will be randomly assigned to either the UV fs-Laser or the WaveLight FS200 Infrared Femtosecond Laser, Model 1025 (IR fs-Laser).
Subjects will attend a total of 6 scheduled study visits, including a preoperative Screening Visit (Day -45 to -1), a Surgery Visit (Day 0), and 4 postoperative visits at Day 1, Week 1, Month 1, and Month 3/exit, for a total individual duration of participation of approximately 4 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| UV fs-Laser/Anesthetic 1 Right, IR fs-Laser/Anesthetic 1 Left | Other | LASIK surgery performed with the UV fs-Laser (right eye) and IR fs-Laser (left eye) as randomized with Anesthetic 1 eye drops |
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| UV fs-Laser/Anesthetic 1 Left, IR fs-Laser/Anesthetic 1 Right | Other | LASIK surgery performed with the UV fs-Laser (left eye) and IR fs-Laser (right eye) as randomized with Anesthetic 1 eye drops |
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| UV fs-Laser/Anesthetic 2 Right, IR fs-Laser/Anesthetic 2 Left | Other | LASIK surgery performed with the UV fs-Laser (right eye) and IR fs-Laser (left eye) as randomized with Anesthetic 2 eye drops |
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| UV fs-Laser/Anesthetic 2 Left, IR fs-Laser/Anesthetic 2 Right | Other | LASIK surgery performed with the UV fs-Laser (left eye) and IR fs-Laser (right eye) as randomized with Anesthetic 2 eye drops |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LASIK Surgery | Procedure | Laser assisted in situ keratomileusis (LASIK) surgery conducted for the purpose of correcting refractive error |
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| Measure | Description | Time Frame |
|---|---|---|
| Difference of intended and achieved flap thickness measured at center (i.e., corneal apex) | Optical coherence tomography (OCT), a non-invasive imaging test that uses light waves to take cross-section pictures, will be used to measure the thickness of the cornea. This endpoint is pre-specified for the UV fs-Laser only. | Month 1 |
| Difference of flap thickness measured between central (i.e., corneal apex) and periphery (i.e., 3 millimeter radius) | Optical coherence tomography (OCT), a non-invasive imaging test that uses light waves to take cross-section pictures, will be used to measure the thickness of the cornea. This endpoint is pre-specified for the UV fs-Laser only. | Month 1 |
| Ability to lift flap at time of surgery | The surgeon will record a response on a questionnaire indicating ability to lift the corneal flap at time of surgery (unable to lift flap / able to lift flap). This endpoint is pre-specified for the UV fs-Laser only. | Day 0 Surgery |
| Ocular adverse events (AEs) related to corneal flap creation with UV fs-Laser and IR fs-Laser | An AE is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users, or other persons. AEs pertaining to corneal flap creation that are attributable to the laser will be recorded. | Day 0 Surgery up through Month 3 |
| Flap-related loss of best-corrected distance visual acuity (BCDVA) greater than or equal to 2 lines (greater than or equal to 10 letters logMAR) at 1 month postoperative or later | Visual acuity will be assessed with correction in place (phoropter or trial frame) at a distance of 4 meters under well-lit conditions using letter charts. |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trial Lead, 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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| UV fs-Laser | Device | WaveLight Ultraviolet Femtosecond Laser used for creating a corneal flap during LASIK surgery |
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| IR fs-Laser | Device | WaveLight FS200 Infrared Femtosecond Laser used for creating a corneal flap during LASIK surgery |
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| Anesthetic 1 eye drops | Device | Topical anesthetic used to numb the surface of the eye |
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| Anesthetic 2 eye drops | Device | Topical anesthetic used to numb the surface of the eye |
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| Month 1 up to Month 3 |
| Number of device deficiencies | A device deficiency is defined as any inadequacy of a medical device with respect to its identity, quality, durability, reliability, usability, safety, or performance. | Day 0 Surgery through Month 3 |