Creating LASIK Flaps With the LenSx Femtosecond Laser

Myopia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01556893
• Other study ID #: CS-004f
• Status: Completed
• Phase: Phase 1
• First received: March 15, 2012
• Last updated: October 23, 2014
• Start date: April 2012
• Est. completion date: March 2013

Study information

• Verified date: October 2014
• Source: Alcon LenSx, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hungary: Research Ethics Medical CommitteeHungary: Institutional Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hyperopia
• Myopia

Intervention

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).

Locations

Country	Name	City	State
Hungary	Department of Ophthalmology, Semmelweis University	Budapest

Sponsors (1)

Lead Sponsor	Collaborator
Alcon LenSx, Inc.

Country where clinical trial is conducted

Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Stromal Bed Quality	0 - very rough; 1- moderately rough 2 - rough 3 - smooth 4 - moderately smooth 5 - very smooth (Scale)	Operative	Yes