The Accuracy of Flap Thickness Versus the Pre-determined Surgical Planning Using WaveLight® FS200
Study Details
Study Description
Brief Summary
The objective is to evaluate the resultant thickness of the FS200 created LASIK flap compared to plan at the surgical visit.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
This study is a Single site, single-arm, prospective, observational study of the accuracy of the intended flap thickness, after successful bilateral LASIK surgery. Subjects will be assessed pre-operatively, operatively and at 1 day post-operatively. Clinical evaluations will include measurement of visual acuity, manifest refraction, and flap thickness, and flap diameter.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| WaveLight® FS200 femtosecond laser Flap creation with the WaveLight® FS200 femtosecond laser |
Device: WaveLight® FS200 femtosecond laser
Flap creation with the WaveLight® FS200 femtosecond laser
|
Outcome Measures
Primary Outcome Measures
- The resultant thickness of the FS200 created LASIK flap compared to plan at the surgical visit. [1 day postoperative]
Secondary Outcome Measures
- The resultant diameter of the FS200 created LASIK flap compared to plan [1 day postoperative]
- Pre-operative Pachymetry as measured by the EX500 versus the Oculus Pentacam [Day 0 (surgical visit)]
Eligibility Criteria
Criteria
Subjects are eligible for the study if they meet the following criteria:
Note: Ocular criteria must be met in both eyes.
-
Appropriate candidate for uncomplicated bilateral LASIK surgery
-
Gender: Males and Females.
-
Age: 18 or older.
-
Refractive error range - SE refractive errors up to 0 to -6D with maximum cylinder up to 3.00D
-
Stable refractive error <0.50D change in preceding year
-
Contact lens wear discontinued 3 days prior to pre-op exam and the procedure
-
Pachymetry above 490μm with residual greater than 270μm
-
Candidates who, as determined by the investigator, can safely undergo LASIK with a 120μm flap
-
Willing and able to provide written informed consent for participation in the study.
-
Willing and able to comply with scheduled visits and other study procedures.
-
Have good general and ocular health, with no pathology that compromises visual acuity (outside of residual refractive error)
If any of the following exclusion criteria are applicable to the subject or either eye, the subject should not be enrolled in the study.
-
Patients with usual relative and absolute contraindications for LASIK surgery (severe dry eye, recurrent corneal erosion, uncontrolled Glaucoma, collagen vascular disorders, keratoconus or signs of keratoconus, uncontrolled Diabetes, Herpes)
-
Pachymetry below 490μm
-
Autoimmune or immunodeficiency diseases
-
Patients with signs of inability to understand consent for study and procedure planned
-
Patients with history of previous ocular surgery
The principal investigator reserves the right to declare a patient ineligible or non- evaluable based on medical evidence that indicates they are unsuitable for the trial.
Pregnancy has a known effect on the stability of refractions and visual acuity. As such, subjects who become pregnant during the study will not be discontinued but their data may be excluded from analyses of effectiveness.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Bismarck Lasik | Bismarck | North Dakota | United States | 58501 |
Sponsors and Collaborators
- Stephen Wexler
- Sengi
Investigators
- Principal Investigator: Stephen Wexler, MD, Bismarck Lasik
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SW-22-001