Clinical trial NCT05501795: The Accuracy of Flap Thickness Versus the Pre-determined Surgical Planning Using WaveLight® FS200
Official title: The Accuracy of Flap Thickness Versus the Pre-determined Surgical Planning Using WaveLight® FS200
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myopia
Keywords: FS200
Lead sponsor: Bismarck Lasik
Sponsor class: OTHER
Collaborators: name: Sengi
First posted: 2022-08-15
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects 18 years of age or older who are interested in and appropriate candidates for LASIK.

Brief summary: The objective is to evaluate the resultant thickness of the FS200 created LASIK flap compared to plan at the surgical visit.

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.

Eligibility 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.

Primary outcomes:
measure: The Resultant Thickness of the FS200 Created LASIK Flap Compared to Plan at the Surgical Visit.
timeFrame: 1 day postoperative
Secondary outcomes:
measure: The Resultant Diameter of the FS200 Created LASIK Flap Compared to Plan
timeFrame: 1 day postoperative
measure: Pre-operative Pachymetry as Measured by the EX500 Versus the Oculus Pentacam
timeFrame: Day 0 (surgical visit)
Other outcomes:
Locations:
city: Bismarck
country: United States
facility: Bismarck Lasik
state: North Dakota
Study officials:
affiliation: Bismarck Lasik
name: Stephen Wexler, MD
role: PRINCIPAL_INVESTIGATOR
References: