NCT01556893

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.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Alcon LenSx, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Myopia
• Hyperopia

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2012-04-01
• Primary completion: 2013-03-01
• Completion: 2013-03-01
• First posted: 2012-03-19
• Last updated: 2014-10-27

Locations

1 site across 1 country: Hungary