NCT02409771

Clinical Trial With PRECIZON Presbyopic

Prospective Multicenter Clinical Trial With the PRECIZON Presbyopic Multifocal Intraocular Lens

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Ophtec BV · Industry
• Sex: All
• Age: 45 Years
• Healthy volunteers: Accepted

Summary

The purpose of this clinical trial is to evaluate the effectiveness of the PRECIZON Presbyopic.

Detailed description

Prospective, open-label, single-arm, multicenter clinical evaluation with a 3 months follow-up. The PRECIZON Presbyopic is a lens intended for implantation in the capsular bag, indicated for optical correction of aphakia in adults whom the crystalline lens has been removed and who desire presbyopia correction. The main objective is to evaluate the ability of the PRECIZON Presbyopic to provide near, intermediate and distance vision in patients undergoing cataract extraction / Clear Lens Exchange (CLE) and intraocular lens implantation. Study results will be used for CE-approval and registration and marketing purposes.

Conditions

• Cataract
• Presbyopia

Interventions

Type	Name	Description
DEVICE	PRECIZON Presbyopic	Optical correction of aphakia in adults in whom the crystalline lens has been removed and who desire presbyopia correction.

Timeline

• Start date: 2015-06-01
• Primary completion: 2017-01-17
• Completion: 2017-01-17
• First posted: 2015-04-07
• Last updated: 2017-04-04

Locations

6 sites across 5 countries: Belgium, Germany, Netherlands, Spain, Turkey (Türkiye)