Ignite Creation Date:
2024-05-06 @ 7:02 PM
Last Modification Date:
2024-10-26 @ 2:59 PM
Study NCT ID:
NCT05875922
Status:
RECRUITING
Last Update Posted:
2024-05-10
First Post:
2023-05-05
Brief Title:
Comparison of ISOPURE and EYHANCE Switzerland
Sponsor:
Beaver-Visitec International Inc
Organization:
Beaver-Visitec International Inc
Study Overview
Official Title:
Prospective Post-Market Clinical Follow-Up PMCF Study to Investigate the Clinical Outcomes of a ISOPURE and EYHANCE Intraocular Lenses IOL
Status:
RECRUITING
Status Verified Date:
2024-05
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:
PHY2301
Brief Summary:
This is a prospective randomised open-label study with the aim to compare the visual performance of the premium monofocal Isopure IOL versus the extended depth of focus Eyhance IOL after phaco-emulsification cataract surgery
Detailed Description:
This is a single center prospective randomised controlled double-blind post-market clinical follow-up PMCF study whereby patients undergoing routine cataract surgery will have bilateral implantation of premium monofocal intraocular lenses PhysIOL ISOPURE 123 or EDOF lenses TECNIS Eyhance The patients will be randomized in a 11 ratio to receive the study or control lenses Both IOLs investigational device and control device are CE approved and commercially available in the countries this clinical investigation is being carried out The investigational device and all study products including the devices used for the study examinations will be used within the intended use specifications from the manufacturer In addition no invasive or other burdening examinations will occur for the patient
The device under investigation ISOPURE 123 is a hydrophobic glistening-free acrylic premium monofocal intraocular lens IOL manufactured by the sponsor of this study PhysIOL sanv The control lens TECNIS Eyhance is a non-diffractive Extended Vision Posterior Chamber IOL
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 6 study visits 1 preoperative 1 operative and 4 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 120-180 days follow up visit
The device under investigation ISOPURE 123 is a hydrophobic glistening-free acrylic premium monofocal intraocular lens IOL manufactured by the sponsor of this study PhysIOL sanv The control lens TECNIS Eyhance is a non-diffractive Extended Vision Posterior Chamber IOL
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 6 study visits 1 preoperative 1 operative and 4 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 120-180 days follow up visit
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