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临床试验/NCT04670237
NCT04670237Enrolling By Invitation不适用

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

Medicontur Medical Engineering Ltd1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2019年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
30
试验地点
1
主要终点
Rotational stability

研究概览

简要总结

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),

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • astigmatism less than 1 dpt
  • irregural astigmatism
  • diabetic retinopathy
  • iris neovascularisation
  • serious intraoperative complications
  • congenital eye abnormality
  • pseudoexfoliation syndrom
  • amblyopia
  • 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

结局指标

主要结局

Rotational stability

时间窗: 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

次要结局

  • Contrast sensitivity(1 year)
  • YAG capsulatomy(1 year)
  • Patient satisfaction(1 year)
  • Visual outcome(1 year)

研究者

发起方
Medicontur Medical Engineering Ltd
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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