Refractive Errors
Conditions
Keywords
LASIK
Brief summary
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.
Detailed description
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.
Interventions
PROCEDURELASIK Surgery
Laser assisted in situ keratomileusis (LASIK) surgery conducted for the purpose of correcting refractive error
DEVICEUV fs-Laser
WaveLight Ultraviolet Femtosecond Laser used for creating a corneal flap during LASIK surgery
DEVICEIR fs-Laser
WaveLight FS200 Infrared Femtosecond Laser used for creating a corneal flap during LASIK surgery
DEVICEAnesthetic 1 eye drops
Topical anesthetic used to numb the surface of the eye
DEVICEAnesthetic 2 eye drops
Topical anesthetic used to numb the surface of the eye
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Eligible for LASIK treatment; * Myopia as specified in the protocol; * Uncorrected distance visual acuity of greater than or equal to 0.30 logMAR; * Best corrected distance visual acuity of less than or equal to 0.10 logMAR; * Presence of clear natural lens (non-cataractous eye); * Other protocol-defined inclusion criteria may apply. Key
Exclusion criteria
* An active implanted device for which laser use may be a contraindication; * Previous ocular surgery; * Ocular conditions that may affect subject safety or impact study outcomes; * Acute or chronic disease or illness that would increase the operative risk or confound the outcomes of the study; * Current use of medications with known ocular side effects and photosensitivity; * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference of intended and achieved flap thickness measured at center (i.e., corneal apex) | Month 1 | 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. |
| Difference of flap thickness measured between central (i.e., corneal apex) and periphery (i.e., 3 millimeter radius) | Month 1 | 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. |
| Ability to lift flap at time of surgery | Day 0 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. |
| Ocular adverse events (AEs) related to corneal flap creation with UV fs-Laser and IR fs-Laser | Day 0 Surgery up through Month 3 | 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. |
| 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 | Month 1 up to Month 3 | 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. |
| Number of device deficiencies | Day 0 Surgery through Month 3 | A device deficiency is defined as any inadequacy of a medical device with respect to its identity, quality, durability, reliability, usability, safety, or performance. |
Countries
Australia
Contacts
STUDY_DIRECTORClinical Trial Lead, Surgical
Alcon Research, LLC
Outcome results
None listed