Creating LASIK Flaps With the LenSx Femtosecond Laser

Prospective, Single-center Clinical Trial of Subjects Scheduled to Undergo LASIK Surgery Requiring an Initial Corneal Flap.

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.

Study Overview

• Status: Completed
• Conditions: Myopia; Hyperopia
• Intervention / Treatment: Device: LenSx Laser

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 1

Contacts and Locations

Study Locations

• Hungary
  • Budapest, Hungary, 1085
    • Department of Ophthalmology, Semmelweis University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ease of Lifting Flaps	0 - Unable to lift flap; - Able to lift flap with aid of sharp instrument; - Able to lift flap with difficulty using blunt instrument; - Able to lift flap with moderate resistance using blunt instrument; - Able to lift flap with minimal resistance using blunt instrument; - Able to lift flap without any resistance using blunt instrument (Scale)	Operative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stromal Bed Quality	0 - very rough 1- moderately rough 2 - rough 3 - smooth 4 - moderately smooth 5 - very smooth (Scale)	Operative

Collaborators and Investigators

• Sponsor: Alcon LenSx, Inc.

Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (Actual): March 1, 2013
• Study Completion (Actual): March 1, 2013

Study Registration Dates

• First Submitted: March 15, 2012
• First Submitted That Met QC Criteria: March 16, 2012
• First Posted (Estimate): March 19, 2012

Study Record Updates

• Last Update Posted (Estimate): October 27, 2014
• Last Update Submitted That Met QC Criteria: October 23, 2014
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Keywords: Femtosecond Laser; Flap Creation; corneal flap prior to LASIK procedure
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Hyperopia
• Other Study ID Numbers: CS-004f