NCT05255029

Clinical Investigation of a Monofocal Toric Intra Ocular Lens (IOL) in Cataractous Eyes

Clinical Investigation of the Monofocal Toric IOL POD T 49P in Cataractous Eyes

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Beaver-Visitec International, Inc. · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

This is a Multi-center, single-arm and non-masked study whereby patients undergoing routine cataract surgery be implanted with a hydrophobic acrylic monofocal toric intraocular lens PODEYE TORIC (model POD T 49P).

Detailed description

This is a Multi-center, single-arm and non-masked study whereby patients undergoing routine cataract surgery will be implanted with a hydrophobic acrylic monofocal toric intraocular lens PODEYE TORIC. The device under investigation is a hydrophobic acrylic monofocal toric intraocular lens (IOL) manufactured by the sponsor of this study (BVI Medical). The refractive power of the lens has a spherical and a cylindrical component. The IOLs will be implanted in the course of routine cataract surgery and will benefit to patients suffering from cataract development and showing pre-existing corneal astigmatism. In total approx. 28 patients, 56 eyes will be recruited for this clinical study and undergo implantation of PODEYE TORIC intraocular lens. Subjects participating in the trial will attend a total of maximum 6 study visits over a period of 120-180 days (preoperative, operative, 1-2 days, 7-14 days, 30-60 days, 120-180 days, postoperative visits). Subjects would have the option for unscheduled visits if required medically.

Conditions

• Cataract
• Lens Opacities
• Astigmatism

Interventions

Type	Name	Description
DEVICE	POD T 49P implantation experimental	The investigational lens will be implanted within the capsular bag after removal of the natural crystalline lens following phacoemulsification and alignment the toric axis of investigational lens to the intend axis which was calculated by the Toric calculator software. When enroll the test lenses into both eyes, the lens is implanted first to the eye with more advanced cataract. If both eyes have a similar degree of cataract, perform the surgery first for the right eye. The timing of surgery the investigational lens into the fellow eye will be determined after the investigator and the investigator (hereinafter referred to as the investigator) have confirmed the safety of the previously operated eye.

Timeline

• Start date: 2021-12-24
• Primary completion: 2023-02-28
• Completion: 2023-02-28
• First posted: 2022-02-24
• Last updated: 2023-07-19

Locations

4 sites across 1 country: Japan