Prospective Evaluation of the Effectiveness of the Femtosecond Laser-assisted Refractive Astigmatic Keratotomy.
This clinical phase IV study is an open, prospective phase IV study and acts to evaluate the effectiveness of the femtolaser-assisted astigmatic keratotomy.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase IV Study_Prospective Evaluation of the Effectiveness of the Femtosecond Laser-assisted Refractive Astigmatic Keratotomy Following the Cataract Surgery.|
- Keratomic corneal astigmatism [ Time Frame: The study endpoints will be calculated for the 3-Months follow-up examination. ] [ Designated as safety issue: No ]The postoperative keratomic corneal astigmatism is in 60% of all eyes equal or better than 1.0D
- Topographic corneal and subjective cylinder [ Time Frame: This end point is measured at the 3 Months Follow Up. ] [ Designated as safety issue: No ]
- 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.
|Study Start Date:||January 2013|
|Study Completion Date:||March 2014|
|Primary Completion Date:||March 2014 (Final data collection date for primary outcome measure)|
|Experimental: Astigmatic keratotomy||
Device: Laser-assisted Astigmatic keratotomy
Laser-assisted Astigmatic keratotomy are performed by the VICTUS™ Femtosecond Laser Platform.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01885780
|Gemini Eye Clinic|
|Zlin, Czech Republic, 76001|
|Principal Investigator:||Pavel Stodulka, Dr. med||Gemini clinic, Zlin|
|Principal Investigator:||Pavel Stodulka, Dr. med||Gemini eye clinic|