NCT01693939

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Feb 2012

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 21, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 26, 2012

Completed
Last Updated

January 25, 2013

Status Verified

January 1, 2013

Enrollment Period

2 months

First QC Date

September 21, 2012

Last Update Submit

January 24, 2013

Conditions

Myopia

Keywords

LasikMyopiaFemtosecond Laser

Outcome Measures

Primary Outcomes (1)

  • Flap Thickness

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

    1 Week Postoperative visit

Secondary Outcomes (1)

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

    Postoperatively 1 month

Other Outcomes (1)

  • Postoperative Satisfaction Survey over Time

    Postoperatively Day 1, Week 1, Month 1

Study Arms (1)

FS200 Femtosecond Laser

OTHER

The LASIK flap will be created using the FS200 Femtosecond Laser

Device: FS200 Femtosecond Laser

Interventions

FS200 Femtosecond LaserDEVICE
FS200 Femtosecond Laser

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Durrie Vision

Overland Park, Kansas, 66211, United States

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Study Officials

  • Daniel S. Durrie, MD

    Durrie Vision

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 21, 2012

First Posted

September 26, 2012

Study Start

February 1, 2012

Primary Completion

April 1, 2012

Study Completion

April 1, 2012

Last Updated

January 25, 2013

Record last verified: 2013-01

Locations

US(1)