Intrastromal Correction of Ametropia by a Femtosecond Laser

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

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.

Sponsors & Collaborators

• 20/10 Perfect Vision

  lead INDUSTRY

Principal Investigators

• Gerd U. Auffarth, Prof. Dr. · Universitäts-Augenklinik Heidelberg

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2008-07-31

Primary Completion

2009-01-31

Completion

2012-12-31

Countries

• Germany

Study Locations