NCT03423524

Clinical Study to Investigate Visual Performance of a Hydrophobic Monofocal IOL After Bilateral Implantation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Beaver-Visitec International, Inc. · Industry
• Sex: All
• Age: 45 Years
• Healthy volunteers: Accepted

Summary

Prospective, non-randomised, open, controlled, single-center post-market clinical follow study about Micropure 1.2.3 IOL.

Detailed description

This clinical investigation is a prospective, non-randomised, open, controlled, single-center post-market clinical follow whereby study patients undergoing routine cataract surgery will have bilateral implantation of monofocal intraocular lenses Micropure 1.2.3. (PhysIOL, Liège, Belgium) The study purpose is to obtain clinical data on visual acuity and contrast sensitivity on patients implanted with Micropure 1.2.3. The device under investigation (Micropure 1.2.3.) is a monofocal glistening-free hydrophobic acrylic intraocular lens (IOL) manufactured by the sponsor of this study PhysIOL sa/nv. The IOL will be implanted as part of the routine cataract surgery on patients suffering from cataract development. In total 50 patients will be recruited for this clinical study and receive a bilateral implantation of Micropure 1.2.3. intraocular lens. Subjects participating in the trial will attend a total of 8 study visits (1 preoperative, 2 operative and 5 postoperative) over a period of 2 Years.

Conditions

• Cataract
• Lens Opacities

Interventions

Type	Name	Description
DEVICE	Micropure 1.2.3.	Implantation of intraocular lens (IOL). Name: "MicroPure 1.2.3." It is a monofocal intraocular lens consisting of hydrophobic acrylic material. One IOL per eye will be implanted

Timeline

• Start date: 2018-05-02
• Primary completion: 2021-07-27
• Completion: 2021-07-27
• First posted: 2018-02-06
• Last updated: 2022-02-15

Locations

1 site across 1 country: Belgium