An observational study in Cataract, sponsored by Medicontur Medical Engineering Ltd. Enrolling by invitation at 1 site in Hungary. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-06-01.
Sponsored by Medicontur Medical Engineering Ltd · Observational
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),
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.
1,701 studies on the registry are indexed under Cataract; 230 are open to participants now.
This study's planned enrollment of 30 is below the median of 81 across 484 observational studies indexed under Cataract.
Browse Cataract studies →Medicontur Medical Engineering Ltd is the lead sponsor of 11 studies on the registry; 3 are open to participants now.
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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.
Inclusion Criteria:
-
Exclusion Criteria:
multifocal, toric intraocular lens (IOL)
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
Time frame: 1 year
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
Time frame: 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
Time frame: 1 year
YAG capsulatomy
The rate of YAG capsulatomy will be assessed during the one year follow-up
Time frame: 1 year
Patient satisfaction
Patient satisfaction will be assessed by using the VFQ-25 questionnaire three month and one year postoperatively
Time frame: 1 year
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Medicontur Medical Engineering Ltd