Prospective Evaluation of the Effectiveness of the Femtosecond Laser-assisted Refractive Astigmatic Keratotomy.
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|ClinicalTrials.gov Identifier: NCT01885780|
Recruitment Status : Completed
First Posted : June 25, 2013
Last Update Posted : June 2, 2014
|Condition or disease||Intervention/treatment||Phase|
|Astigmatism||Device: Laser-assisted Astigmatic keratotomy||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||45 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase IV Study_Prospective Evaluation of the Effectiveness of the Femtosecond Laser-assisted Refractive Astigmatic Keratotomy Following the Cataract Surgery.|
|Study Start Date :||January 2013|
|Actual Primary Completion Date :||March 2014|
|Actual Study Completion Date :||March 2014|
|Experimental: Astigmatic keratotomy||
Device: Laser-assisted Astigmatic keratotomy
Laser-assisted Astigmatic keratotomy are performed by the VICTUS™ Femtosecond Laser Platform.
- 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
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|