Clinical Trial: Prospective Evaluation of the Effectiveness of the Femtosecond Laser-assisted Refractive Astigmatic Keratotomy.

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Phase IV Study_Prospective Evaluation of the Effectiveness of the Femtosecond Laser-assisted Refractive Astigmatic Keratotomy Following the Cataract Surgery.

Brief Summary: This clinical phase IV study is an open, prospective phase IV study and acts to evaluate the effectiveness of the femtolaser-assisted astigmatic keratotomy.

Detailed Summary:

The purpose of this prospective phase IV study acts to address the predictability and effectiveness of astigmatic keratotomy in eyes after femtolaser-assisted cataract surgery. Within this prospective data collection the laser-assisted Arcuate Incisions are performed by the VICTUS™ Femtosecond Laser Platform.

This study will be conducted at Gemini eye clinic in Zlin, Czech Republic by Dr. Pavel Stodulka who will treat up to 50 eyes. Patients will be recruited according to the study inclusion/exclusion criteria.


Sponsor: Technolas Perfect Vision GmbH

Current Primary Outcome: Keratomic corneal astigmatism [ Time Frame: The study endpoints will be calculated for the 3-Months follow-up examination. ]

The postoperative keratomic corneal astigmatism is in 60% of all eyes equal or better than 1.0D


Original Primary Outcome: Same as current

Current Secondary Outcome: Topographic corneal and subjective cylinder [ Time Frame: This end point is measured at the 3 Months Follow Up. ]

  • The postoperative astigmatism in topography is in 60% of all eyes equal or better than 1.0D
  • The postoperative subjective astigmatism in manifest refraction is in 60% of all eyes equal or better than 1D.


Original Secondary Outcome: Same as current

Information By: Technolas Perfect Vision GmbH

Dates:
Date Received: June 11, 2013
Date Started: January 2013
Date Completion:
Last Updated: May 30, 2014
Last Verified: May 2014