NCT04699266

Clinical Investigation of the Multifocal IOL POD F GF in Cataracteous Eyes

Clinical Investigation of the Multifocal Intraocular Lens (IOL) POD F GF in Cataracteous Eyes

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Beaver-Visitec International, Inc. · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

To evaluate effectiveness and safety of the POD F GF Intraocular Lens (IOL) when implanted to replace the natural lens following cataract removal

Detailed description

Since the investigational lens, like conventional IOLs, is a posterior chamber lens which is widely implanted following cataract extraction, phacoemulsification is adopted. To assess the binocular vision, the investigational lens will be bilaterally implanted. Considering the safety of the study subjects, the time of implant to the remaining eye (2nd eye) will be decided based on the results of the 1st implant.

Conditions

• Cataract
• Lens Opacities
• Presbyopia

Interventions

Type	Name	Description
DEVICE	Assigned Intervention (POD F GF)	The investigational lens (POD F GF )will be implanted to both eyes in subjects with bilateral cataract. Registration of patients and the implantation of the investigational lens (POD F GF) will be conducted in consideration of securing 44 eyes in 22 subjects as the analysis subjects

Timeline

• Start date: 2020-11-01
• Primary completion: 2021-08-30
• Completion: 2021-08-30
• First posted: 2021-01-07
• Last updated: 2023-08-01

Locations

1 site across 1 country: Japan