Ignite Creation Date:
2024-07-17 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06469541
Status:
COMPLETED
Last Update Posted:
2024-06-21
First Post:
2023-05-31
Brief Title:
Clinical Outcomes After Implantation of a Monofocal Hydrophobic IOL Bi-Flex 877PAY With POB-MA Preloaded Injector
Sponsor:
Medicontur Medical Engineering Ltd
Organization:
Medicontur Medical Engineering Ltd
Study Overview
Official Title:
Clinical Outcomes After Implantation of a Monofocal Hydrophobic IOL Bi-Flex 877PAY With POB-MA Preloaded Injector Visual Outcomes Refractive Stability Safety Features YAG Capsulotomy Rate Retrospective Review
Status:
COMPLETED
Status Verified Date:
2023-04
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:
The purpose of our investigation is to retrospectively assess visual outcomes refractive stability safety features of the lens and the incidence of developing PCO posterior capsular opacification in a 12-month period following mono- or bilateral implantation of the hydrophobic acrylic monofocal IOL Bi-Flex 877PAY Medicontur
Detailed Description:
The purpose of our investigation is to retrospectively assess visual outcomes refractive stability safety features of the lens and the incidence of developing PCO posterior capsular opacification in a 12-month period following mono- or bilateral implantation of the hydrophobic acrylic monofocal IOL Bi-Flex 877PAY Medicontur
Primary objective
o To evaluate the monocular Uncorrected Distance Visual Acuity UCDVA 1 year after IOL implantation
Secondary objectives
To evaluate the spherical equivalent refraction one month postoperatively
To evaluate level of astigmatism one month postoperatively
To evaluate the Uncorrected Distance Visual Acuity UDVA monocular at 1 day 1 month and 6 months after IOL implantation
To evaluate the Best Corrected Distance Visual Acuity CDVA monocular at 1 month 6 months and 1 year after IOL implantation
To evaluate safety features of the lens
To evaluate PCO development NdYAG capsulotomy rate
Primary objective
o To evaluate the monocular Uncorrected Distance Visual Acuity UCDVA 1 year after IOL implantation
Secondary objectives
To evaluate the spherical equivalent refraction one month postoperatively
To evaluate level of astigmatism one month postoperatively
To evaluate the Uncorrected Distance Visual Acuity UDVA monocular at 1 day 1 month and 6 months after IOL implantation
To evaluate the Best Corrected Distance Visual Acuity CDVA monocular at 1 month 6 months and 1 year after IOL implantation
To evaluate safety features of the lens
To evaluate PCO development NdYAG capsulotomy rate
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