Ignite Creation Date:
2024-05-06 @ 3:34 PM
Last Modification Date:
2024-10-26 @ 1:51 PM
Study NCT ID:
NCT04670237
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2023-06-01
First Post:
2020-12-10
Brief Title:
Clinical Outcome After Implantation of Medicontur Liberty 677MTY a Multifocal Toric IOL
Sponsor:
Medicontur Medical Engineering Ltd
Organization:
Medicontur Medical Engineering Ltd
Study Overview
Official Title:
Clinical Outcome After Implantation of Medicontur Multifocal Toric Intraocular Lens Liberty 677MTY Rotational Stability Visual Outcomes Patients Satisfaction YAG Capsulotomy Rate
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2023-05
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:
None
Brief Summary:
The purpose of this study is to evaluate visual outcomes patient satisfaction and YAG capsulotomy rate after implantation of a multifocal toric lens- Liberty 677MTY - manufactured by Medicontur Ltd Zsámbék Hungary
Detailed Description:
The purpose of this study is to evaluate visual outcomes glass independency visual disturbances glares halos neuronal adaptation and patient satisfaction after implantation of multifocal diffractive apodized toric intraocular lens- Liberty 677MTY - diffractive-refractive apodized IOL based on EPS technology manufactured by Medicontur Ltd Zsámbék Hungary
The tested IOL model Liberty 677MTY has an overall length of 13 mm an optic diameter of 60 mm without haptics angulations but with posterior vaulting The refractive index of the optic material is 146 at 23C The IOL is a single-piece-IOL the optic and haptics are made from a hydrophilic acrylic co-polymer with integrated - covalently bound UV absorbent The IOL is produced with yellow filter covalently bound yellow chromophore The toric component of Liberty 677MTY IOL is located on the posterior surface of the lens optic The optic is marked with 2 marks The marks are positioned exactly in middle between the two loops of haptic at the angulation at the flat axis of toric equivalent The Liberty 677MTY is available with cylinder powers of 10 diopter D to 60 D The IOL is designed with sharp edge following 360º to prevent migration of the lens epithelial cells thereby to prevent PCO formation
The trifocality of the lens is provided by the EPS technology recently developed by Medicontur uses an elevated phase shift on the central diffractive part of the lens in order to cause constructive interference between the 0th far and 1st diffractive near order thus creating a 3rd intermediate focal point
The tested IOL model Liberty 677MTY has an overall length of 13 mm an optic diameter of 60 mm without haptics angulations but with posterior vaulting The refractive index of the optic material is 146 at 23C The IOL is a single-piece-IOL the optic and haptics are made from a hydrophilic acrylic co-polymer with integrated - covalently bound UV absorbent The IOL is produced with yellow filter covalently bound yellow chromophore The toric component of Liberty 677MTY IOL is located on the posterior surface of the lens optic The optic is marked with 2 marks The marks are positioned exactly in middle between the two loops of haptic at the angulation at the flat axis of toric equivalent The Liberty 677MTY is available with cylinder powers of 10 diopter D to 60 D The IOL is designed with sharp edge following 360º to prevent migration of the lens epithelial cells thereby to prevent PCO formation
The trifocality of the lens is provided by the EPS technology recently developed by Medicontur uses an elevated phase shift on the central diffractive part of the lens in order to cause constructive interference between the 0th far and 1st diffractive near order thus creating a 3rd intermediate focal point
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