Clinical trial NCT04670237: Clinical Outcome After Implantation of Medicontur Liberty 677MTY, a Multifocal, Toric IOL
Official title: Clinical Outcome After Implantation of Medicontur Multifocal, Toric Intraocular Lens Liberty 677MTY: Rotational Stability, Visual Outcomes, Patients' Satisfaction, YAG Capsulotomy Rate
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cataract
Lead sponsor: Medicontur Medical Engineering Ltd
Sponsor class: INDUSTRY
First posted: 2020-12-17
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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 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.

Eligibility criteria: Inclusion Criteria:

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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

Primary outcomes:
measure: Rotational stability
timeFrame: 1 year
Secondary outcomes:
measure: Visual outcome
timeFrame: 1 year
measure: Contrast sensitivity
timeFrame: 1 year
measure: YAG capsulatomy
timeFrame: 1 year
measure: Patient satisfaction
timeFrame: 1 year
Other outcomes:
Locations:
city: Budapest
country: Hungary
facility: Semmelweis University, Department of Ophthalmology
Study officials:
References: