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

Sponsor
Medicontur Medical Engineering Ltd (Industry)
Overall Status
Enrolling by invitation
CT.gov ID
NCT04670237
Collaborator
(none)
30
Enrollment
1
Location
25
Anticipated Duration (Months)
1.2
Patients Per Site Per Month

Study Details

Study Description

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),

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Actual Enrollment :
30 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Clinical Outcome After Implantation of Medicontur Multifocal, Toric Intraocular Lens Liberty 677MTY: Rotational Stability, Visual Outcomes, Patients' Satisfaction, YAG Capsulotomy Rate
Actual Study Start Date :
Dec 1, 2019
Anticipated Primary Completion Date :
Dec 31, 2021
Anticipated Study Completion Date :
Dec 31, 2021

Outcome Measures

Primary Outcome Measures

  1. Rotational stability [1 year]

    Rotational stability will be measured using slit lamp images of the implanted lens on day one, seven, month one, three and one year postoperatively

Secondary Outcome Measures

  1. Visual outcome [1 year]

    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

  2. Contrast sensitivity [1 year]

    Contrast sensitivity will be assessed by using the CSV-1000 method in photopic and mesopic light condition three month and one year after implantation

  3. YAG capsulatomy [1 year]

    The rate of YAG capsulatomy will be assessed during the one year follow-up

  4. Patient satisfaction [1 year]

    Patient satisfaction will be assessed by using the VFQ-25 questionnaire three month and one year postoperatively

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 86 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Semmelweis University, Department of Ophthalmology Budapest Hungary H-1085

Sponsors and Collaborators

  • Medicontur Medical Engineering Ltd

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Medicontur Medical Engineering Ltd
ClinicalTrials.gov Identifier:
NCT04670237
Other Study ID Numbers:
  • MC_Liberty677MTY_HU_2019
First Posted:
Dec 17, 2020
Last Update Posted:
Dec 17, 2020
Last Verified:
Dec 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Cataract

Study Results

No Results Posted as of Dec 17, 2020