NCT05776095

Evaluation of Safety and Performance Outcomes of Eyedeal IOL Implantation After Cataract Removal

A Prospective, Multicenter Study to Evaluate Safety and Performance Outcomes of Eyedeal Intraocular Lens Implantation After Cataract Removal

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 97 (estimated)
• Sponsor: Xi'an Eyedeal Medical Technology Co., Ltd · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

Summary

A cataract is the clouding of the natural lens in the eye and is very common as when getting older. A cloudy lens makes it difficult to see. A cataract is treated by removing the cloudy lens and replacing it with an intraocular lens (known as an IOL). The goal of this clinical trial is to determine if the Eyedeal® IOL can be safely implanted in a subject's eye and if it can replace efficiently the natural lens. Subjects will be asked to attend a total of seven visits for this study for a period of 12 months after surgery.

Detailed description

To investigate the safety and performance of the Eyedeal® PX65AS1 intraocular lens (IOL) * To evaluate the safety profile with regards to best-corrected visual acuity, and adverse events * To evaluate the performance with regards of best corrected distance VA after the device implantation The Eyedeal® IOL (PX65AS1) is a foldable single-piece ultra-violet absorbing posterior chamber intraocular lens (IOL). It is an optical implant to replace the human crystalline lens in the visual correction of aphakia in adult patients after cataract removal. The Eyedeal® PX65AS1 IOL lens is made of a high refractive index soft cross-linked polyolefin. The Eyedeal® PX65AS1 IOL lens has an aspheric optic with symmetric optic design and spherical neutral and correct lens's own spherical aberration supporting haptics to provide proper position of the IOL optic within the capsule.

Conditions

• Lens Implantation, Intraocular

Interventions

Type	Name	Description
PROCEDURE	Cataract surgery	Subjects will undergo surgery to remove cataract (the cloudy lenses) via phacoemulsification, and implant the Eyedeal® Model PX65AS1 IOL in the eye capsule.
DEVICE	Eyedeal® Model PX65AS1 IOL	Subjects will undergo surgery to remove cataract (the cloudy lenses) via phacoemulsification, and implant the Eyedeal® Model PX65AS1 IOL in the eye capsule.

Timeline

• Start date: 2023-11-10
• Primary completion: 2025-02-28
• Completion: 2025-02-28
• First posted: 2023-03-20
• Last updated: 2024-02-02

Locations

2 sites across 2 countries: Germany, Lithuania