NCT02112968

A Prospective Safety and Effectiveness Study of a New High Repetition Rate Excimer Laser Using LASIK for the Correction of Ammetropia and Presbyopia

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 97 (estimated)
• Sponsor: Technolas Perfect Vision GmbH · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This clinical study has been planned to evaluate the safety and effectiveness of common treatment algorithms using 500 Hz laser repetition rate for the correction of Ammetropia and Presbyopia

Detailed description

This clinical study has been planned to evaluate the safety and effectiveness of the excimer laser treatment algorithms Proscan, Zyoptix and Supracor of the 500 Hz laser system for ametropia and/or presbyopia when performed on the cornea of virgin eyes.

Conditions

• Myopia
• Hyperopia
• Presbyopia

Interventions

Type	Name	Description
PROCEDURE	Proscan	One device (500 Hz Excimer Laser) with three interventions (Proscan, Zyoptix and Supracor as algorithms)
PROCEDURE	Zyoptix	One device (500 Hz Excimer Laser) with three interventions (Proscan, Zyoptix and Supracor as algorithms)
PROCEDURE	Supracor	One device (500 Hz Excimer Laser) with three interventions (Proscan, Zyoptix and Supracor as algorithms)

Timeline

• Start date: 2014-12-01
• Primary completion: 2016-02-01
• Completion: 2017-05-01
• First posted: 2014-04-14
• Last updated: 2014-11-20