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

Last updated: May 31, 2023
Sponsor: Medicontur Medical Engineering Ltd
Overall Status: Active - Enrolling

Phase

N/A

Condition

Eye Disorders/infections

Eye Disease

Vision Loss

Treatment

Liberty677MTY Multifocal Toric IOL

Clinical Study ID

NCT04670237
MC_Liberty677MTY_HU_2019
  • Ages > 18
  • All Genders

Study 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),

Eligibility Criteria

Inclusion

Inclusion Criteria:

Exclusion

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 Design

Total Participants: 30
Treatment Group(s): 1
Primary Treatment: Liberty677MTY Multifocal Toric IOL
Phase:
Study Start date:
December 01, 2019
Estimated Completion Date:
December 31, 2023

Study 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.

Connect with a study center

  • Semmelweis University, Department of Ophthalmology

    Budapest, H-1085
    Hungary

    Site Not Available

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