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

Clinical Outcome After Implantation of Medicontur Multifocal, Toric Intraocular Lens Liberty 677MTY: Rotational Stability, Visual Outcomes, Patients' Satisfaction, YAG Capsulotomy Rate

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),

Study Overview

• Status: Enrolling by invitation
• Conditions: Cataract
• Intervention / Treatment: Device: Liberty677MTY Multifocal Toric IOL

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 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.

• Study Type: Observational
• Enrollment (Estimated): 30

Contacts and Locations

Study Locations

• Hungary
  • Budapest, Hungary, H-1085
    • Semmelweis University, Department of Ophthalmology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 86 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The enrolled subjects will be the patients with cataract and pre-existing regular corneal astigmatism between 1.0 to 6.0 dpt. (Cylindric power of IOLs will range between 1.0 to 6.0 dpts). The patients will be indicated for cataract surgery and toric IOL implantation by the clinical investigator. The study will be conducted according to the tenets of the Declaration of Helsinki and patients will give informed consent after the nature and intent of study will be fully explained to them.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rotational stability	Rotational stability will be measured using slit lamp images of the implanted lens on day one, seven, month one, three and one year postoperatively	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual outcome	Monocular and binocular visual aquity will be measured at far, intermediate and near by standard ETDRS chart at month one, three and one year postoperatively	1 year
Contrast sensitivity	Contrast sensitivity will be assessed by using the CSV-1000 method in photopic and mesopic light condition three month and one year after implantation	1 year
YAG capsulatomy	The rate of YAG capsulatomy will be assessed during the one year follow-up	1 year
Patient satisfaction	Patient satisfaction will be assessed by using the VFQ-25 questionnaire three month and one year postoperatively	1 year

Collaborators and Investigators

• Sponsor: Medicontur Medical Engineering Ltd

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2019
• Primary Completion (Estimated): December 31, 2023
• Study Completion (Estimated): December 31, 2023

Study Registration Dates

• First Submitted: December 10, 2020
• First Submitted That Met QC Criteria: December 10, 2020
• First Posted (Actual): December 17, 2020

Study Record Updates

• Last Update Posted (Actual): June 1, 2023
• Last Update Submitted That Met QC Criteria: May 31, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: MC_Liberty677MTY_HU_2019

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No