Ignite Creation Date:
2024-05-06 @ 8:26 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06380478
Status:
RECRUITING
Last Update Posted:
2024-04-24
First Post:
2024-04-18
Brief Title:
Safety and Efficacy of the Bi-Aspheric Monofocal IOL
Sponsor:
ICARES Medicus Inc
Organization:
ICARES Medicus Inc
Study Overview
Official Title:
Safety and Efficacy of the Bi-Aspheric Monofocal Intraocular Lens
Status:
RECRUITING
Status Verified Date:
2024-04
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:
This is an observational single-center non-control open-label post-marketing study Patients implanted with an aspicio Monofocal Intraocular Lens will be scheduled for a follow-up visit at least 3 months after the surgery to undergo a routine basic ophthalmological examination
Detailed Description:
This is an observational single-center non-control open-label post-marketing study Patients implanted with an aspicio Monofocal Intraocular Lens will be scheduled for a single visit in the facilities of Chang Gung University Hospital at least 3 months after the surgery Patients will undergo a routine basic ophthalmological examination
Additionally and retrospectively the patients medical records will be reviewed to obtain information on visual acuity and adverse events at postoperative visit carried out 1 month after surgery
The data corresponding to the preoperative values of corneal curvature flat meridian curved meridian and axes axial length measured by biometry visual acuity and those corresponding to the implanted IOL will also be collected from the medical records
Additionally and retrospectively the patients medical records will be reviewed to obtain information on visual acuity and adverse events at postoperative visit carried out 1 month after surgery
The data corresponding to the preoperative values of corneal curvature flat meridian curved meridian and axes axial length measured by biometry visual acuity and those corresponding to the implanted IOL will also be collected from the medical records
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