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

This study has been completed.
Sponsor:
Collaborator:
Alcon Laboratories
Information provided by (Responsible Party):
Durrie Vision
ClinicalTrials.gov Identifier:
NCT01693939
First received: September 21, 2012
Last updated: January 24, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention Phase
Myopia
Device: FS200 Femtosecond Laser
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Single Center Prospective Evaluation of the Post-LASIK Flap Thickness of the FS200 Femtosecond Laser Flap

Further study details as provided by Durrie Vision:

Primary Outcome Measures:
  • Flap Thickness [ Time Frame: 1 Week Postoperative visit ] [ Designated as safety issue: No ]
    The flap thickness will be measured one week postoperative using the Visante OCT and the Optivue OCT devices


Secondary Outcome Measures:
  • Change in Uncorrected Visual Acuity at 1 Day, 1 Week, and 1 Month Postoperatively [ Time Frame: Postoperatively 1 month ] [ Designated as safety issue: No ]
    Change in Uncorrected visual acuity will be measured at 1 Day, 1 week, and 1 month postoperatively


Other Outcome Measures:
  • Postoperative Satisfaction Survey over Time [ Time Frame: Postoperatively Day 1, Week 1, Month 1 ] [ Designated as safety issue: No ]
    Subject questionnaire will be administered to evaluate overall patient satisfaction postoperatively


Enrollment: 30
Study Start Date: February 2012
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
FS200 Femtosecond Laser
The LASIK flap will be created using the FS200 Femtosecond Laser
Device: FS200 Femtosecond Laser

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01693939

Locations
United States, Kansas
Durrie Vision
Overland Park, Kansas, United States, 66211
Sponsors and Collaborators
Durrie Vision
Alcon Laboratories
Investigators
Principal Investigator: Daniel S. Durrie, MD Durrie Vision
  More Information

No publications provided

Responsible Party: Durrie Vision
ClinicalTrials.gov Identifier: NCT01693939     History of Changes
Other Study ID Numbers: FT-FS200-001
Study First Received: September 21, 2012
Last Updated: January 24, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Durrie Vision:
Lasik
Myopia
Femtosecond Laser

ClinicalTrials.gov processed this record on October 02, 2014