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Clinical Trial Summary

This is a single-center, prospective PMCF study whereby patients undergoing routine cataract surgery will have monolateral implantation of hydrophilic monofocal toric intraocular lens Ankoris.


Clinical Trial Description

This is a single-center, prospective, nonrandomized PMCF study whereby patients undergoing routine cataract surgery will have monolateral implantation of hydrophilic monofocal toric intraocular lens (Ankoris). The device under investigation is manufactured by the sponsor of this study. The refractive power of the lens has a spherical and a cylindrical component. The IOLs will be implanted in the course of routine cataract surgery and will benefit to patients suffering from cataract development and showing pre-existing corneal astigmatism. The primary objective of this study is to determine the rotational stability of the Ankoris intraocular lens. The secondary objective is to measure the residual astigmatism after Ankoris implantation with respect to the targeted astigmatism correction. In total approx. 20 eyes of 20 patients will be recruited for this clinical study. Follow-ups will be performed 1 day, 1 month, and 3 months after cataract surgery. Subjects would have the option for unscheduled visits if required medically. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04933487
Study type Interventional
Source Beaver-Visitec International, Inc.
Contact
Status Completed
Phase N/A
Start date August 26, 2014
Completion date March 2019

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