Clinical Study to Investigate Visual Performance of IOL: FineVision HP

Status Completed

Clinical Trial Summary

This is a prospective, non-randomised, controlled, single-surgeon, single-center post-market clinical follow up study whereby patient undergoing routine cataract surgery will have bilateral implantation of a recently introduced TGA (Therapeutics Goods Authority, Australia) approved trifocal intraocular lens FineVision Evo (PhysIOL, Liège, Belgium). The primary and secondary effectiveness data for visual acuity, defocus curves, contrast sensitivity and any adverse events will be collected.

Clinical Trial Description

Subjects participating in the trial will attend a total of 8 study visits (1 preoperative, 2 operative and 5 postoperative) over a period of 3 months, same as the surgeon's standard follow up protocol for bilateral cataract surgery with IOL implantation. Subjects would have the option for unscheduled visits if required medically. Primary endpoint data will be collected at the final visit. Data analyses will be done in the end to support the study publication plan. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03027024
Study type	Interventional
Source	Beaver-Visitec International, Inc.
Contact
Status	Completed
Phase	N/A
Start date	February 27, 2017
Completion date	October 22, 2018

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