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Clinical Trials/NCT01977807
NCT01977807UnknownPhase 4

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

Technolas Perfect Vision GmbH2 sites in 1 country100 target enrollmentStarted: August 2014Last updated:
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Conditions

Trial Snapshot

Phase
Phase 4
Enrollment
100
Locations
2
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
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study 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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 85 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (2)

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