The Accuracy of Flap Thickness Versus the Pre-determined Surgical Planning Using WaveLight® FS200

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

Study Overview

• Status: Completed
• Conditions: Myopia
• Intervention / Treatment: Device: WaveLight® FS200 femtosecond laser

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 Type: Observational
• Enrollment (Actual): 58

Contacts and Locations

Study Locations

• United States
  • North Dakota
    • Bismarck, North Dakota, United States, 58501
      • Bismarck Lasik

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Subjects 18 years of age or older who are interested in and appropriate candidates for LASIK.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The Resultant Thickness of the FS200 Created LASIK Flap Compared to Plan at the Surgical Visit.	1 day postoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Thickness measurements compared between 2 devices: the EX500 and the Oculus Pentacam	Day 0 (surgical visit)

Collaborators and Investigators

• Sponsor: Stephen Wexler
• Collaborators: Sengi
• Investigators: Principal Investigator: Stephen Wexler, MD, Bismarck Lasik

Study record dates

Study Major Dates

• Study Start (Actual): August 9, 2022
• Primary Completion (Actual): January 19, 2023
• Study Completion (Actual): January 19, 2023

Study Registration Dates

• First Submitted: August 12, 2022
• First Submitted That Met QC Criteria: August 12, 2022
• First Posted (Actual): August 15, 2022

Study Record Updates

• Last Update Posted (Actual): July 12, 2024
• Last Update Submitted That Met QC Criteria: June 18, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: FS200
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: SW-22-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes