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临床试验/NCT05895396
NCT05895396已完成不适用

Comparison of Clinical Outcome After Implantation With Two Different Multifocal Toric Intraocular Lens: Liberty Trifocal 677MTY (Medicontur) and PanOptix® Multifocal Toric (Alcon) Lens, With Respect to 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 35 人开始时间: 2020年9月14日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
35
试验地点
1
主要终点
Rotational stability

研究概览

简要总结

This study is to compare the rotational stability, visual outcome and patient satisfaction after implantation with either Liberty 677MTY, a multifocal diffractive-refractive IOL based on EPS technology manufactured by Medicontur Ltd. (Zsámbék, Hungary) or the multifocal toric IOL PanOptix®, manufactured by Alcon.

详细描述

According to numerous estimations, 15% to 29% of patients with cataract have more than 1.5 diopters of refractive astigmatism. Corneal astigmatism can be reduced with a variety of surgical techniques including selective positioning of the phacoemulsification incision, corneal relaxing incision, implantation of toric IOLs, photorefractive keratectomy and there are first results of implantation of short arc-length intrastromal corneal ring segments for correcting astigmatism and myopia . The use of toric IOLs to reduce visually significant keratometric astigmatism offers a rational, more predictable and stable method of refractive correction. Implanting a toric intraocular lens offers the possibility of correcting not only spherical equivalent of refraction, but also astigmatism. The success of a toric IOL can be judged not only by its ability to reduce refractive astigmatism immediately postoperatively, but also by its ability to maintain a stable position in the capsular bag in the longer term. Even a small rotational deviation of the toric IOL from its intended axis can result in large reduction of the astigmatic correction.

The purpose of this study is to evaluate and compare the visual outcomes, spectacle independency, visual disturbances (glares, halos), neuronal adaptation and patient satisfaction after implantation of either the Liberty 677MTY (a multifocal diffractive apodized toric intraocular lens- diffractive-refractive IOL based on EPS technology manufactured by Medicontur Ltd. Zsámbék, Hungary) or the multifocal toric PanOptix® IOL, manufactured by Alcon.

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

  • The enrolled subjects will be the patients with cataract and pre-existing regular corneal astigmatism between 1.0 to 6.0 dpt.

排除标准

  • astigmatism less than 1 dpt
  • irregular 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

次要结局

  • Visual outcome (UDVA, CDVA, UIVA, DCIVA, UNVA, DCNVA)(1 year)
  • Contrast sensitivity defocus curve(1 year)
  • Contrast sensitivity(1 year)
  • Multifocality (Visual Acuity Defocus Curve)(1 year)
  • Patient satisfaction(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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