NCT01322919

Safety and Efficacy Study to Evaluate the Treatment of Both Near and Distance Vision in a Simultaneous Laser Procedure

A Prospective Study to Evaluate the Safety and Effectiveness of the Presbyopic LASIK Algorithm

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: Technolas Perfect Vision GmbH · Industry
• Sex: All
• Age: 45 Years – 85 Years
• Healthy volunteers: Accepted

Summary

By using a new software two consecutive laser treatments have been combined to correct the distance vision and to provide a near vision component in addition to the first treatment. This study will help us to answer 2 questions: 1. How accurately this combined technique corrects distance and near vision 2. Whether the correction is adequate to remove the complete need for supplementary near spectacles

Detailed description

LASIK is a surgical technique where the cornea is reshaped using a laser to provide visual correction. Typically, this procedure will only correct your long distance vision requiring the use of supplementary spectacles for reading and near vision. The Technolas 217z Excimer Laser used to deliver the treatment is approved for use in the European Community for both treatment versions to correct separately the near vision and the distance vision for cases which need one or the other correction. By using a new software two consecutive treatments have been combined to correct the distance vision and to provide a near vision component in addition to the first treatment. This study will help us to answer 2 questions: 1. How accurately this combined technique corrects distance and near vision 2. Whether the correction is adequate to remove the complete need for supplementary near spectacles

Conditions

• Myopia
• Hyperopia
• Presbyopia
• Refractive Error

Interventions

Type	Name	Description
PROCEDURE	Supracor	All patients will undergo LASIK treatment on their non-dominant eye with a new laser software algorithm designed to treat both the distance and near vision components. The developed software algorithm uses the subjective refraction of the eye to create a treatment for the distance vision correction. This part of the treatment does not show any difference to a regular LASIK treatment for ametropic cases. In addition to the treatment for the distance vision a central ablation component will be added to address the near vision.

Timeline

• Start date: 2010-04-01
• Primary completion: 2012-02-01
• Completion: 2012-03-01
• First posted: 2011-03-25
• Last updated: 2015-05-20

Locations

1 site across 1 country: Mexico