Ignite Creation Date:
2024-05-06 @ 6:46 PM
Last Modification Date:
2024-10-26 @ 2:54 PM
Study NCT ID:
NCT05776095
Status:
RECRUITING
Last Update Posted:
2024-02-02
First Post:
2023-02-17
Brief Title:
Evaluation of Safety and Performance Outcomes of Eyedeal IOL Implantation After Cataract Removal
Sponsor:
Xian Eyedeal Medical Technology Co Ltd
Organization:
Xian Eyedeal Medical Technology Co Ltd
Study Overview
Official Title:
A Prospective Multicenter Study to Evaluate Safety and Performance Outcomes of Eyedeal Intraocular Lens Implantation After Cataract Removal
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 subjects 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
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 lenss own spherical aberration supporting haptics to provide proper position of the IOL optic within the capsule
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 lenss own spherical aberration supporting haptics to provide proper position of the IOL optic within the capsule
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None