Clinical Investigation of a Femtosecond Laser for Corneal Flap Creation
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.
Study details:
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.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
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
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 exclusion criteria may apply
Eligibility
Age eligible for study : NA
Healthy volunteers accepted : No
Gender eligible for study: ALL
Things to know
Study dates
Study start:
Primary completion:
Study completion finish:
Study type
TREATMENT
Phase
- NA
Study ID
NCT07036835
Intervention or treatment
PROCEDURE: LASIK Surgery
DEVICE: UV fs-Laser
DEVICE: IR fs-Laser
DEVICE: Anesthetic 1 eye drops
DEVICE: Anesthetic 2 eye drops
Conditions
- Refractive Errors
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Research sites nearby
Closest Location:
Personaleyes
Select from list below to view details:
Personaleyes
Sydney, New South Wales, Australia
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Who is running the clinical trial?
Alcon Research
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
| Participant Group/Arm | Intervention/Treatment |
|---|---|
OTHER: UV fs-Laser/Anesthetic 1 Right, IR fs-Laser/Anesthetic 1 Left
| Procedure: LASIK Surgery, Device: UV fs-Laser, Device: IR fs-Laser, Device: Anesthetic 1 eye drops |
OTHER: UV fs-Laser/Anesthetic 1 Left, IR fs-Laser/Anesthetic 1 Right
| Procedure: LASIK Surgery, Device: UV fs-Laser, Device: IR fs-Laser, Device: Anesthetic 1 eye drops |
OTHER: UV fs-Laser/Anesthetic 2 Right, IR fs-Laser/Anesthetic 2 Left
| Procedure: LASIK Surgery, Device: UV fs-Laser, Device: IR fs-Laser, Device: Anesthetic 2 eye drops |
OTHER: UV fs-Laser/Anesthetic 2 Left, IR fs-Laser/Anesthetic 2 Right
| Procedure: LASIK Surgery, Device: UV fs-Laser, Device: IR fs-Laser, Device: Anesthetic 2 eye drops |
What is the study measuring?
Primary Outcome
| 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. | 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 |
Secondary Outcome
References
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