NCT03027024

Clinical Study to Investigate Visual Performance of IOL: FineVision HP

Clinical Study to Investigate Visual Performance of Hydrophobic Trifocal IOL: FineVision HP

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Beaver-Visitec International, Inc. · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Cataract
• Lens Opacity

Interventions

Type	Name	Description
DEVICE	Implantation of IOL: PhysIOL POD F GF	Implantation of trifocal IOL POD F GF consisting of hydrophobic material

Timeline

• Start date: 2017-02-27
• Primary completion: 2018-10-22
• Completion: 2018-10-22
• First posted: 2017-01-20
• Last updated: 2021-05-06

Locations

1 site across 1 country: Australia