Working… Menu

Creating LASIK Flaps With the LenSx Femtosecond Laser

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01556893
Recruitment Status : Completed
First Posted : March 19, 2012
Last Update Posted : October 27, 2014
Information provided by (Responsible Party):
Alcon LenSx, Inc.

Brief Summary:

This will be a prospective, single-center clinical trial of up to 50 eyes of subjects scheduled to undergo LASIK surgery requiring an initial corneal flap. Subjects will be screened for eligibility.

Subjects will undergo LASIK surgery using the LenSx Laser to create the corneal flap prior to excimer laser treatment.

Subjects will be evaluated intraoperatively to assess the ease of lifting the flaps, the stromal bed quality, and the amount of opaque bubble layer. All patients will be followed with routine vision exams for 3 months postoperatively to evaluate changes in visual acuity, manifest refraction, slit lamp examination, and endothelial cell counts.

Condition or disease Intervention/treatment Phase
Myopia Hyperopia Device: LenSx Laser Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective, Single-center Clinical Trial of Subjects Scheduled to Undergo LASIK Surgery Requiring an Initial Corneal Flap.
Study Start Date : April 2012
Actual Primary Completion Date : March 2013
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
LASIK Flap Arm
This is a single arm study.
Device: LenSx Laser
The LenSx laser system is a femtosecond laser that has received 510(k) clearance for anterior capsulotomy during cataract surgery (K082947), laser phacofragmentation during cataract surgery (K094052) and for use in the creation of a single and multi-plane arc cut/incisions in the cornea (K092647).

Primary Outcome Measures :
  1. Ease of Lifting Flaps [ Time Frame: Operative ]

    0 - Unable to lift flap

    1. - Able to lift flap with aid of sharp instrument
    2. - Able to lift flap with difficulty using blunt instrument
    3. - Able to lift flap with moderate resistance using blunt instrument
    4. - Able to lift flap with minimal resistance using blunt instrument
    5. - Able to lift flap without any resistance using blunt instrument (Scale)

Secondary Outcome Measures :
  1. Stromal Bed Quality [ Time Frame: Operative ]

    0 - very rough

    1- moderately rough 2 - rough 3 - smooth 4 - moderately smooth 5 - very smooth (Scale)

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  1. Must have myopia or hyperopia eligible for femtosecond initiated LASIK surgery
  2. Must be over 18 years of age
  3. Must have visual acuity correctable to at least 20/25 in both eyes
  4. If subject is a contact lens wearer, discontinuation of contact lens wear prior to preoperative exam (2 weeks prior for soft contact lenses, 4 weeks prior for rigid gas permeable contact lenses, and 8 weeks prior for hard contact lenses)
  5. Must be willing and able to return for scheduled follow up examinations through 3 months after surgery
  6. Must sign and be given a copy of the written Informed Consent form
  7. Postoperative refractive target is emmetropia

Exclusion Criteria:

  1. Known sensitivity to planned study concomitant medications
  2. Participation in any other ophthalmic drug or device clinical trial during the time of this clinical investigation
  3. Presenting any contraindications to femtosecond initiated LASIK
  4. Corneal thickness values that will result in residual bed less than 280 microns when flap resection and excimer ablation are calculated
  5. Irregular astigmatism, based on Investigator's judgment
  6. Undergoing monovision LASIK
  7. Pregnant, lactating or plan to become pregnant during the course of this study
  8. For bilateral second study eyes only: The surgeon shall not proceed with the second eye until the 1 week exam of the first eye shows no vision threatening complications.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01556893

Layout table for location information
Department of Ophthalmology, Semmelweis University
Budapest, Hungary, 1085
Sponsors and Collaborators
Alcon LenSx, Inc.
Layout table for additonal information
Responsible Party: Alcon LenSx, Inc. Identifier: NCT01556893    
Other Study ID Numbers: CS-004f
First Posted: March 19, 2012    Key Record Dates
Last Update Posted: October 27, 2014
Last Verified: October 2014
Keywords provided by Alcon LenSx, Inc.:
Flap Creation
Femtosecond Laser
corneal flap prior to LASIK procedure
Additional relevant MeSH terms:
Layout table for MeSH terms
Refractive Errors
Eye Diseases