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CompletedNCT01693939Updated Jan 25, 2013

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

A Phase 4 interventional study of FS200 Femtosecond Laser in Myopia, sponsored by Durrie Vision. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-01-25.

Sponsored by Durrie Vision · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Myopia

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Keywords

  • Lasik
  • Myopia
  • Femtosecond Laser
03

In context

Myopia

984 studies on the registry are indexed under Myopia; 210 are open to participants now.

This study's enrollment of 30 is below the median of 80 across 783 interventional studies indexed under Myopia.

Browse Myopia studies →

Lead sponsor

Durrie Vision is the lead sponsor of 6 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

EXCLUSION CRITERIA

The following are exclusion criteria for study patients in this study:

  • A patient with evidence of keratoconus, corneal irregularity, or abnormal videokeratography in either eye
  • A patient requiring the use of any ocular drop(s) and/or medication(s) in either eye during the study period with the exception of ocular drops and/or medications provided by the investigator
  • A patient having any surgical procedure within a week preceding the scheduled LASIK surgery
  • A patient with any UNCONTROLLED systemic disease (i.e., a potential patient in whom therapy for a systemic disease is not yet stabilized )
  • A patient with a history of prior intraocular or corneal surgery (including cataract extraction), clinically significant ophthalmic disease or abnormality (including, but not limited to, uncontrolled clinically significant blepharitis, clinically significant recurrent corneal erosion, clinically significant dry eye syndrome, clinically significant lens opacity, evidence of clinically significant trauma (including scarring inside the visual axis), or evidence of glaucoma or propensity for narrow angle glaucoma in either eye
  • A patient with a significant history or current evidence of a medical, psychological or other disorder that, in the investigator's opinion, may increase the risk associated with study participation or may interfere with the interpretation of study results
  • A patient with a history of any of the following medical conditions, or any other condition that could affect wound healing: uncontrolled diabetes, collagen vascular disease, autoimmune disease, immunodeficiency diseases, ocular herpes zoster or simplex, endocrine disorders (including, but not limited to unstable thyroid disorders and diabetes), lupus, and rheumatoid arthritis
  • A female patient who is pregnant, nursing, planning a pregnancy during the study, or thinks she may be pregnant at the start of the study
  • Current participation or participation within 30 days prior to the start of this study in a drug or other investigational device research study.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (actual)

Study arms

  • Other
    FS200 Femtosecond Laser

    The LASIK flap will be created using the FS200 Femtosecond Laser

    Device: FS200 Femtosecond Laser

Interventions

  • DeviceFS200 Femtosecond Laser
06

What researchers measure

Primary outcomes

  1. Flap Thickness

    The flap thickness will be measured one week postoperative using the Visante OCT and the Optivue OCT devices

    Time frame: 1 Week Postoperative visit

Secondary outcomes

  1. Change in Uncorrected Visual Acuity at 1 Day, 1 Week, and 1 Month Postoperatively

    Change in Uncorrected visual acuity will be measured at 1 Day, 1 week, and 1 month postoperatively

    Time frame: Postoperatively 1 month

Other outcomes

  1. Postoperative Satisfaction Survey over Time

    Subject questionnaire will be administered to evaluate overall patient satisfaction postoperatively

    Time frame: Postoperatively Day 1, Week 1, Month 1

07

Study locations

1 site
  • Durrie Vision
    Overland Park, Kansas 66211, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 25, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01693939
Lead sponsor
Durrie Vision
Collaborators
Alcon Research
Responsible party
Sponsor
First posted
Sep 26, 2012
Start date
Feb 2012
Primary completion
Apr 2012
Completion
Apr 2012
Last update
Jan 25, 2013

Study contacts

Daniel S. Durrie, MD
principal investigator · Durrie Vision

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2013. You cannot join it, but the record below documents what was studied.

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