Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06578910
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-06-10
Brief Title:
Retrospective Non-interventional Clinical Investigation of the Safety and Performance of 640AD Monofocal Intraocular Lens
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Retrospective Non-interventional Clinical Investigation of the Safety and Performance of 640AD Monofocal Intraocular Lens
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Medicontur hydrophilic posterior chamber monofocal intraocular lens IOL is indicated to improve vision at far distance in adults with cataract andor ametropia hyperopia myopia secondarily to removal of the crystalline lens
The intraocular lens is intended to be surgically implanted into the eye with the purpose of restoring optical function in the aphakic eye to provide an optical system with high predictability of the precalculated dioptric power
The study will be performed partially as a retrospective study with patients enrolled who had been implanted with 640AD IOLs mono- or binocularly between December 2021 - December 2022
Data from five visits will be collected
Baseline preoperative maximum 30 days prior to surgery- retrospective
IOL implantation Day 0 - retrospective
Postoperative visit at Day 1 - 0 days - retrospective
Postoperative visit at 1 month - 2 weeks - retrospective
Postoperative visit at 12 months - 3 months - consent and prospective visit
The intraocular lens is intended to be surgically implanted into the eye with the purpose of restoring optical function in the aphakic eye to provide an optical system with high predictability of the precalculated dioptric power
The study will be performed partially as a retrospective study with patients enrolled who had been implanted with 640AD IOLs mono- or binocularly between December 2021 - December 2022
Data from five visits will be collected
Baseline preoperative maximum 30 days prior to surgery- retrospective
IOL implantation Day 0 - retrospective
Postoperative visit at Day 1 - 0 days - retrospective
Postoperative visit at 1 month - 2 weeks - retrospective
Postoperative visit at 12 months - 3 months - consent and prospective visit
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None