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

Completed
Conditions
Myopia
Interventions
Device: WaveLight® FS200 femtosecond laser
Registration Number
NCT05501795
Lead Sponsor
Stephen Wexler
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
58
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
WaveLight® FS200 femtosecond laserWaveLight® FS200 femtosecond laserFlap creation with the WaveLight® FS200 femtosecond laser
Primary Outcome Measures
NameTimeMethod
The Resultant Thickness of the FS200 Created LASIK Flap Compared to Plan at the Surgical Visit.1 day postoperative
Secondary Outcome Measures
NameTimeMethod
Pre-operative Pachymetry as Measured by the EX500 Versus the Oculus PentacamDay 0 (surgical visit)

Thickness measurements compared between 2 devices: the EX500 and the Oculus Pentacam

The Resultant Diameter of the FS200 Created LASIK Flap Compared to Plan1 day postoperative

Trial Locations

Locations (1)

Bismarck Lasik

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Bismarck, North Dakota, United States

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