Clinical Outcome After Implantation of Medicontur Liberty 677MTY, a Multifocal, Toric IOL

Medicontur

Status: Invitation-only

Conditions: Cataract

Treatments: Device: Liberty677MTY Multifocal Toric IOL

Study type: Observational

Funder types: Industry

Identifiers

NCT04670237

MC_Liberty677MTY_HU_2019

Details and patient eligibility

About

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),

Full 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 6.0 mm without haptics angulations but with posterior vaulting. The refractive index of the optic material is 1.46 (at 23°C). 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 1.0 diopter (D) to 6.0 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Exclusion criteria

• astigmatism less than 1 dpt
• irregural astigmatism
• diabetic retinopathy
• iris neovascularisation
• serious intraoperative complications
• congenital eye abnormality
• glaucoma
• pseudoexfoliation syndrom
• amblyopia
• uveitis
• long-term anti-inflammatory treatment
• AMD (advanced AMD)
• retinal detachment
• prior ocular surgery in personal medical history
• corneal diseases
• severe retinal diseases (dystrophy, degeneration)
• severe myopia (if required IOL power is lower than 10 D)
• inadequate visualization of the fundus on preoperative examination
• patients deemed by the clinical investigator because of any systemic disease.
• eye trauma in medical history intraoperative exclusions:
• tear in capsulorhexis
• zonular dehiscence
• posterior capsular rupture
• vitreous loss and other unexpected surgical complication