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

Stephen Wexler

Status

Completed

Conditions

Myopia

Treatments

Device: WaveLight® FS200 femtosecond laser

Study type

Observational

Funder types

Other

Industry

Identifiers

NCT05501795

SW-22-001

Details and patient eligibility

About

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

Full 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.

Enrollment

58 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.