NCT04987216

PMCF Study on Monofocal Toric IOL (PODEYE TORIC) in Europe (PHY2104)

Multicentric Prospective Post-market Clinical Follow-Up (PMCF) Study to Investigate Clinical Outcomes, Rotational Stability and Patient Reported Outcomes After Implantation of a Monofocal Toric Intraocular Lens (IOL)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Beaver-Visitec International, Inc. · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

This is a multicentric, prospective, open-label PMCF study whereby patients undergoing routine cataract surgery will have mono- or bilateral implantation of hydrophobic acrylic monofocal toric intraocular lens PODEYE TORIC (study no. PHY2104)

Detailed description

This is a multicentric, prospective, open-label PMCF study whereby patients undergoing routine cataract surgery will have mono- or bilateral implantation of 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. 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. If only one eye qualifies for toric lens implantation due to small amount of pre-existing corneal astigmatism, one eye will be implanted with PODEYE TORIC and the contralateral eye will be received an implantation with the monofocal parent lens PODEYE. The study purpose is to determine safety, rotational stability, refractive and visual performance, contrast sensitivity, patient satisfaction and PCO rate after mono- or bilateral implantation of PODEYE TORIC intraocular lens. In total approx. 30 patients will be recruited for this clinical study and undergo mono- or bilateral implantation of PODEYE TORIC intraocular lens. The maximum time between 1st and 2nd eye implantation is 30 days. Subjects participating in the trial will attend a total of maximum 11 study visits over a period of 330-420 days (preoperative, operative, 1-2 days, 7-14 days, 30-60 days, 120-180 days, 330-420 days postoperative visits). Subjects would have the option for unscheduled visits if required medically.

Conditions

• Cataract
• Lens Opacities
• Astigmatism

Interventions

Type	Name	Description
DEVICE	IOL implantation experimental	Mono- or bilateral implantation of toric intraocular lenses PODEYE TORIC. If only one eye qualifies for toric lens implantation due to small amount of pre-existing corneal astigmatism, one eye will be implanted with PODEYE TORIC and the contralateral eye will be receive an implantation with the monofocal parent lens PODEYE (PhysIOL sa/nv, Liège, Belgium).

Timeline

• Start date: 2021-10-27
• Primary completion: 2023-06-26
• Completion: 2024-03-14
• First posted: 2021-08-03
• Last updated: 2024-08-20

Locations

4 sites across 1 country: Germany