A Prospective Safety and Effectiveness Study of the 500 Hz Technolas Perfect Vision Excimer Laser in Asian Eyes Using LASIK

Technolas Perfect Vision GmbH1 site in 1 country100 target enrollmentAugust 2014

ConditionsMyopia Hyperopia Presbyopia

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Myopia
Sponsor: Technolas Perfect Vision GmbH
Enrollment: 100
Locations: 1
Primary Endpoint: For Proscan and Zyoptix: - The percentage of treated eyes within +/- 0.50D of target refraction. For Supracor: - The percentage of treated eyes with a best corrected high contrast distance VA of Snellen 20/25 (6/7.5 or 0.1 logMAR) or better
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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

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.

Registry

clinicaltrials.gov

Start Date

August 2014

End Date

December 2016

Last Updated

10 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Technolas Perfect Vision GmbH

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Outcomes

Primary Outcomes

For Proscan and Zyoptix: - The percentage of treated eyes within +/- 0.50D of target refraction. For Supracor: - The percentage of treated eyes with a best corrected high contrast distance VA of Snellen 20/25 (6/7.5 or 0.1 logMAR) or better

Time Frame: Myopia: 6 months, Hyperopia 12 months