Clinical Trial: Prospective Evaluation of the Long-term Effectiveness of the Femtosecond Laser-assisted Arcuate Incisions

Study Status: Not yet recruiting
Recruit Status: Unknown status
Study Type: Observational

Official Title: Prospective Evaluation of the Long-term (18 Months) Effectiveness of the Femtosecond Laser-assisted Arcuate Incisions Following Cataract Surgery

Brief Summary: This clinical study is an open, controlled, prospective, single center, single-surgeon, post-market-clinical-follow-up study to evaluate the long-term (18 months) effectiveness of the femtolaser-assisted astigmatic keratotomy.

Detailed Summary:

The purpose of this prospective post-market-clinical-follow-up study is to address the long-term effectiveness of arcuate incisions, in eyes after VICTUS femtosecond laser-assisted astigmatic keratotomy.

This study will be conducted at Gemini eye clinic in Zlin, Czech Republic by Dr. Pavel Stodulka who will examine up to 100 eyes who previously received VICTUS femtolaser-assisted arcuate incisions treatment.

Patients will be recruited according to the study inclusion/exclusion criteria.


Sponsor: Technolas Perfect Vision GmbH

Current Primary Outcome: Postoperative keratometric cylinder [ Time Frame: 18 months after the VICTUS femtosecond laser-assisted arcuate incisions. ]

Postoperative Astigmatism (keratometry) ≤ 1.0 D in 60% of eyes


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Postoperative Manifest Cylinder [ Time Frame: 19 months after VICTUS femtosecond laser-assisted arcuate incisions treatment. ]
    Postoperative Manifest Astigmatism (manifest refraction) ≤ 1.0 D in 60% of eyes
  • Postoperative Objective Cylinder [ Time Frame: 18 months after VICTUS femtosecond laser-assisted arcuate incisions treatment. ]
    Postoperative Objective Astigmatism (manifest refraction) ≤ 1.0 D in 60% of eyes


Original Secondary Outcome: Same as current

Information By: Technolas Perfect Vision GmbH

Dates:
Date Received: June 13, 2014
Date Started: April 2014
Date Completion: November 2015
Last Updated: April 23, 2015
Last Verified: April 2015