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Contralateral Study of WaveLight® Femtosecond Laser Devices for Corneal Flap Creation
The purpose of this study is to assess the WaveLight Ultraviolet Femtosecond Laser System, Model 1026 (UV fs-Laser) corneal flap creation accuracy as compared to the already marketed WaveLight FS200 Infrared Femtosecond Laser, Model 1025 (IR fs-Laser).
Study details:
Subjects who qualify to participate will have both eyes treated in the study (one eye with the UV fs-Laser and the other eye with the IR fs-Laser) and will attend a total of 5 study visits over a period of approximately 2 months. This study will be conducted outside the United States.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2023-10-20
Primary completion: 2024-12-01
Study completion finish: 2024-12-01
Study type
TREATMENT
Phase
NA
Trial ID
NCT06021353
Intervention or treatment
DEVICE: UV fs-Laser
DEVICE: IR fs-Laser
PROCEDURE: LASIK
Conditions
- • Refractive Errors
Find a site
Closest Location:
Personaleyes
Research sites nearby
Select from list below to view details:
Personaleyes
Sydney, New South Wales, Australia
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
| DEVICE: UV fs-Laser
|
OTHER: IR fs-Laser
| DEVICE: IR fs-Laser
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
Maximum deviation of corneal flap thickness at the margins from achieved central flap thickness at 1 month | Corneal flap thickness will be measured using optical coherence tomography (OCT) | Month 1 |
Secondary outcome
Frequently Asked Questions
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