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

Myopia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05501795
• Other study ID #: SW-22-001
• Status: Completed
• Start date: August 9, 2022
• Est. completion date: January 19, 2023

Study information

• Verified date: February 2023
• Source: Bismarck Lasik
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: January 19, 2023
• Est. primary completion date: January 19, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Myopia

Intervention

Device:
• WaveLight® FS200 femtosecond laser
Flap creation with the WaveLight® FS200 femtosecond laser

Locations

Country	Name	City	State
United States	Bismarck Lasik	Bismarck	North Dakota

Sponsors (2)

Lead Sponsor	Collaborator
Stephen Wexler	Sengi

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The resultant thickness of the FS200 created LASIK flap compared to plan at the surgical visit.		1 day postoperative
Secondary	The resultant diameter of the FS200 created LASIK flap compared to plan		1 day postoperative
Secondary	Pre-operative Pachymetry as measured by the EX500 versus the Oculus Pentacam		Day 0 (surgical visit)