NCT03796624

Clinical Outcomes of MICROPURE and PodEye Monofocal Intraocular Lenses

Comparison of Clinical Outcomes After Implantation of MICROPURE (PhysIOL) and PodEye (PhysIOL) Monofocal Intraocular Lenses Into the Two Eyes of the Same Patient

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 76 (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. and PODEYE intraocular lenses.

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 implantation of monofocal intraocular lens Micropure 1.2.3. (PhysIOL, Liège, Belgium) in one eye and implantation of monofocal intraocular lens PODEYE (PhysIOL, Liège, Belgium) in the contralateral eye of the same patient. The study purpose is to obtain clinical data on visual acuity and contrast sensitivity on patients implanted with Micropure 1.2.3. and PODEYE The devices under investigation (Micropure 1.2.3. and PODEYE) are a monofocal glistening-free hydrophobic acrylic intraocular lenses (IOLs) manufactured by the sponsor of this study PhysIOL sa/nv. The optical properties of the lenses are very comparable. The main difference is the mechanical design of the haptics, that is not expected to have an influence on the clinical outcomes. The IOLs will be implanted as part of the routine cataract surgery on patients suffering from cataract development. In total 76 patients will be recruited for this clinical study and receive the implantation of Micropure 1.2.3. and POPDEYE intraocular lenses. Subjects participating in the trial will attend study visits over a period of 12 months.

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 patient will be implanted
DEVICE	PODEYE	Implantation of intraocular lens (IOL). Name: "PODEYE" It is a monofocal intraocular lens consisting of hydrophobic acrylic material. The IOL will be implanted in the contralateral eye of the same patient already implanted with Micropure 1.2.3.

Timeline

• Start date: 2019-02-12
• Primary completion: 2021-06-17
• Completion: 2021-06-17
• First posted: 2019-01-08
• Last updated: 2021-07-09

Locations

1 site across 1 country: Czechia