Creating LASIK Flaps With the LenSx Femtosecond Laser

Phase 1

Completed

• Conditions: Hyperopia; Myopia
• Interventions: Device: LenSx Laser

• Registration Number: NCT01556893
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-03-15
• Study First Submitted QC: 2012-03-16
• Study First Posted: 2012-03-19
• Study Start: 2012-04
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-23
• Last Update Posted: 2014-10-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
LASIK Flap Arm	LenSx Laser	This is a single arm study.

Primary Outcome Measures

Name	Time	Method
Ease of Lifting Flaps	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

Name	Time	Method
Stromal Bed Quality	Operative	0 - very rough; 1- moderately rough 2 - rough 3 - smooth 4 - moderately smooth 5 - very smooth (Scale)

Trial Locations

Locations (1)

Department of Ophthalmology, Semmelweis University; 🇭🇺 Budapest, Hungary