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

Phase 4

• Conditions: Myopia; Hyperopia; Presbyopia
• Interventions: Device: Proscan, Zyoptix and Supracor

• Registration Number: NCT01977807
• Lead Sponsor: Technolas Perfect Vision GmbH

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.

Study Timeline

• Study First Submitted: 2013-10-31
• Study First Submitted QC: 2013-10-31
• Study First Posted: 2013-11-07
• Study Start: 2014-08
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-19
• Last Update Posted: 2015-05-20
• Primary Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Myopia	Proscan, Zyoptix and Supracor	Myopia Lasik treatment of virgin eyes.
Hyperopia	Proscan, Zyoptix and Supracor	Hyperopia Lasik treatment of virgin eyes.

Primary Outcome Measures

Name	Time	Method
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	Myopia: 6 months, Hyperopia 12 months

Trial Locations

Locations (1)

Asian Eye Institut; 🇵🇭 Manila, Philippines