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Creating LASIK Flaps With the LenSx Femtosecond Laser

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon LenSx, Inc.
ClinicalTrials.gov Identifier:
NCT01556893
First received: March 15, 2012
Last updated: October 23, 2014
Last verified: October 2014
  Purpose

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 Intervention Phase
Myopia
Hyperopia
Device: LenSx Laser
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prospective, Single-center Clinical Trial of Subjects Scheduled to Undergo LASIK Surgery Requiring an Initial Corneal Flap.

Further study details as provided by Alcon LenSx, Inc.:

Primary Outcome Measures:
  • Ease of Lifting Flaps [ Time Frame: Operative ] [ Designated as safety issue: Yes ]

    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:
  • Stromal Bed Quality [ Time Frame: Operative ] [ Designated as safety issue: Yes ]

    0 - very rough

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



Enrollment: 20
Study Start Date: April 2012
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).

  Eligibility

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

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.
  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: NCT01556893

Locations
Hungary
Department of Ophthalmology, Semmelweis University
Budapest, Hungary, 1085
Sponsors and Collaborators
Alcon LenSx, Inc.
  More Information

No publications provided

Responsible Party: Alcon LenSx, Inc.
ClinicalTrials.gov Identifier: NCT01556893     History of Changes
Other Study ID Numbers: CS-004f
Study First Received: March 15, 2012
Last Updated: October 23, 2014
Health Authority: Hungary: Research Ethics Medical Committee
Hungary: Institutional Ethics Committee

Keywords provided by Alcon LenSx, Inc.:
Flap Creation
Femtosecond Laser
corneal flap prior to LASIK procedure

ClinicalTrials.gov processed this record on November 20, 2014