NCT00928122

Intrastromal Correction of Ametropia by a Femtosecond Laser

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: 20/10 Perfect Vision · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study evaluates the intrastromal correction of ametropia with a femtosecond laser made by 20/10 PERFECT VISION. This laser generates a beam of ultrashort, infrared pulses which enables very precise cuts in the cornea. By these cuts lamellae of the cornea are separated locally, and in the consequence the curvature of the cornea is changed, and the correction of the diagnosed ametropia can be achieved. On the contrary to cuts which are generated with a sharp knife, the cuts generated when using a laser can be generated just inside the cornea without opening the surface of the cornea. This means the procedure is minimal-invasive. The study hypothesis is: Different types of ametropia can be corrected safely and on long-term by intrastromal cuts.

Conditions

• Presbyopia
• Myopia
• Hyperopia
• Astigmatism

Interventions

Type	Name	Description
DEVICE	Intrastromal Correction of Presbyopia	Applying defined, pre-programmed patterns (e.g. rings and/or radial cuts)into the human eye cornea. It is a minimal-invasive procedure which changes the topography of the cornea and by that the refraction ability.
DEVICE	Intrastromal correction of Myopia	Applying defined, pre-programmed patterns (e.g. rings and/or radial cuts)into the human eye cornea. It is a minimal-invasive procedure which changes the topography of the cornea and by that the refraction ability.
DEVICE	Intrastromal Correction of Hyperopia	Applying defined, pre-programmed patterns (e.g. rings and/or radial cuts)into the human eye cornea. It is a minimal-invasive procedure which changes the topography of the cornea and by that the refraction ability.
DEVICE	Intrastromal Correction of Myopia incl. Astigmatism	Applying defined, pre-programmed patterns (e.g. rings and/or radial cuts)into the human eye cornea. It is a minimal-invasive procedure which changes the topography of the cornea and by that the refraction ability.
DEVICE	Intrastromal Correction of Hyperopia incl. Astigmatism	Applying defined, pre-programmed patterns (e.g. rings and/or radial cuts)into the human eye cornea. It is a minimal-invasive procedure which changes the topography of the cornea and by that the refraction ability.

Timeline

• Start date: 2008-07-01
• Primary completion: 2009-01-01
• Completion: 2012-12-01
• First posted: 2009-06-25
• Last updated: 2010-02-09

Locations

3 sites across 1 country: Germany