Evaluation of the Post-LASIK Flap Thickness of the FS200 Femtosecond Laser Flap

A Single Center Prospective Evaluation of the Post-LASIK Flap Thickness of the FS200 Femtosecond Laser Flap

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01693939

Enrollment

Registered

2012-09-26

Start date

2012-02-29

Completion date

2012-04-30

Last updated

2013-01-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myopia

Keywords

Lasik, Myopia, Femtosecond Laser

Brief summary

The purpose of this study is to document the programmed flap thickness to achieved flap thickness using the FS200 femtosecond laser in performing LASIK procedure. The FS200 Femtosecond laser is a precision surgical device that is used to create a flap in a FDA approved LASIK procedure.

Detailed description

The objective of this study is to evaluate the thickness of the corneal flap created with the FS 200 Femtosecond laser flap during the LASIK procedure using the Visante and OptiVue OCT ultrasound devices.

Interventions

DEVICEFS200 Femtosecond Laser

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

The following are requirements for a potential study patient's inclusion into the study: * Male or female in good general health, 18 years of age or older at the time of the pre-operative examination * Patient must be able to read, comprehend and willing to give HIPPA and informed consent * Patient is planning to undergo a bilateral LASIK procedure * Both eyes must have a manifest refractive error from -1.00 to -7.00D spherical equivalent with less than or equal to 3.00 D of refractive astigmatism as expressed in spectacle minus cylinder form * Both eyes must have a BSCVA of 20/25 or better * Both eyes must demonstrate refractive stability confirmed by clinical records or previous glasses. Refractive stability shall be documented by a change of less than or equal to 0.50 diopter per year (sphere and cylinder) or as documented by clinical judgment by the investigator.

Exclusion criteria

The following are

Design outcomes

Primary

Measure	Time frame	Description
Flap Thickness	1 Week Postoperative visit	The flap thickness will be measured one week postoperative using the Visante OCT and the Optivue OCT devices

Secondary

Measure	Time frame	Description
Change in Uncorrected Visual Acuity at 1 Day, 1 Week, and 1 Month Postoperatively	Postoperatively 1 month	Change in Uncorrected visual acuity will be measured at 1 Day, 1 week, and 1 month postoperatively

Other

Measure	Time frame	Description
Postoperative Satisfaction Survey over Time	Postoperatively Day 1, Week 1, Month 1	Subject questionnaire will be administered to evaluate overall patient satisfaction postoperatively

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026