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

NCT ID: NCT05501795

Last Updated: 2024-07-12

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 58 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-08-09
• Study Completion Date: 2023-01-19

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.

Conditions

Myopia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

WaveLight® FS200 femtosecond laser

Flap creation with the WaveLight® FS200 femtosecond laser

WaveLight® FS200 femtosecond laser

Intervention Type: DEVICE

Flap creation with the WaveLight® FS200 femtosecond laser

Interventions

WaveLight® FS200 femtosecond laser

Flap creation with the WaveLight® FS200 femtosecond laser

Intervention Type: DEVICE

Eligibility Criteria

Inclusion 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)

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sengi

INDUSTRY

Sponsor Role: collaborator

Stephen Wexler

OTHER

Sponsor Role: lead

Responsible Party

Stephen Wexler

Medical Director and Surgeon

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Stephen Wexler, MD

Role: PRINCIPAL_INVESTIGATOR

Bismarck Lasik

Locations

Bismarck Lasik

Bismarck, North Dakota, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

SW-22-001

Identifier Type: -

Identifier Source: org_study_id