NCT03688399

Comparison of Clinical Outcomes POD L GF vs POD F GF (PHY1707)

Clinical Study to Compare Clinical Outcomes of Hydrophobic Trifocal IOLs FineVision POD F GF and FineVision POD L GF After Bilateral Implantation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 53 (actual)
• Sponsor: Beaver-Visitec International, Inc. · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Accepted

Summary

Prospective, randomised, controlled, single-surgeon, single-center clinical study to compare the clinical outcomes of two trifocal IOLs differing in the dominance of additional power. The investigational device POD L GF shows dominance for the intermediate addition (+1.75 D), whereas the control device POD F GF shows dominance for the near addition (+3.5 D). Implantation of the IOLs is bilaterally.

Detailed description

This is a prospective, randomised, controlled, single-surgeon, single-center clinical study whereby patients undergoing routine cataract surgery will have bilateral implantation of trifocal intraocular lenses. The patients will either be implanted with the hydrophobic IOL FineVision POD L GF or the hydrophobic IOL FineVision POD F GF (both lenses: (PhysIOL, Liège, Belgium). The devices under investigation (FineVision POD L GF and POD F GF) are trifocal glistening-free acrylic intraocular lenses (IOLs) manufactured by the sponsor of this study PhysIOL sa/nv. Both consist of the same hydrophobic material. The main difference between the lenses is the dominance of additional power. The investigational device POD L GF shows dominance for the intermediate addition (+1.75 D), whereas the control device POD F GF shows dominance for the near addition (+3.5 D). The IOLs will be implanted as part of the routine cataract surgery on patients suffering from cataract development. Subjects participating in the trial will attend a total of 10 study visits (1 preoperative, 2 operative and 7 postoperative) over a period of 6 months. Subjects would have the option for unscheduled visits if required medically. Primary and secondary endpoint data will be collected at the 6 months follow up visit. Data analyses will be done after the last patient finished the final examination to support the study publication plan.

Conditions

• Cataract
• Lens Opacity
• Presbyopia

Interventions

Type	Name	Description
DEVICE	IOL implantation experimental	Implantation of trifocal IOL POD F GF consisting of light distribution order: far \> intermediate \> near
DEVICE	IOL implantation comparator	Implantation of trifocal IOL POD F GF consisting of light distribution order: far \> near \> intermediate

Timeline

• Start date: 2018-07-30
• Primary completion: 2021-02-01
• Completion: 2021-09-21
• First posted: 2018-09-28
• Last updated: 2022-01-11

Locations

1 site across 1 country: Hungary