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Rotational Stability of the Acunex Vario Toric

2026年11月3日 更新者:Prim. Prof. Dr. Oliver Findl, MBA

Evaluation of the Rotational Stability of the Acunex Vario Toric Intraocular Lens

Efficacy of the rotational stability and astigmatism correction of a toric EDOF IOL, the Acunex Vario toric.

研究概览

地位

招聘中

条件

干预/治疗

详细说明

Recent advances in cataract surgery technology have transformed the procedure from a purely vision-restoring approach into a procedure for correcting presbyopia. Patients' resulting higher expectations regarding freedom from spectacles have led to advances in intraocular lens (IOL) technology in recent years. The implantation of a standard monofocal IOL designed to achieve emmetropia results in a high level of patient satisfaction with regard to distance vision. However, spectacles are still required for intermediate and near vision.

One approach to achieving freedom from spectacles at all distances is the use of multifocal IOLs. Compared with monofocal IOLs, however, these lenses are more frequently associated with photic phenomena such as glare and halos, as well as reduced contrast sensitivity. Another approach to minimize the need for spectacles is the use of IOLs with extended depth of focus (EDOF). These lenses feature an extended distance focus range that extends into the intermediate range, thereby offering high visual quality across a continuous focus range. Unlike trifocal IOLs, which split the light into different focal points, the extended focus of these IOLs is designed to improve contrast perception in the intermediate range and reduce light-related phenomena.

Furthermore, residual corneal astigmatism is an important factor in achieving post-operative freedom from spectacles, and its correction is necessary to achieve the best possible visual performance. The most widely used and effective approach to correcting corneal astigmatism is the implantation of a toric IOL. To ensure that these lenses achieve the desired effect, they must be positioned precisely along the intended axis, as any rotation of a toric IOL can reduce its ability to correct astigmatism.

Particularly in the case of IOLs designed to correct presbyopia, such as trifocal or EDOF lenses, it is therefore important to correct corneal astigmatism in order to achieve the best possible post-operative visual outcome. The aim of this study is therefore to analyze the efficacy and rotational stability of a toric EDOF IOL (Acunex Vario toric, AN6VT).

38 eyes from 38 patients will be included into the study, into each eye an AN6VT IOL will be implanted. Follow-up examinations will take place 1 hour, 1 week after surgery on the first eye and 1 week after surgery on the second eye, and 4-6 months post-operatively.

研究类型

介入性

注册 (估计的)

38

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

  • 姓名:Johannes Zeilinger, MD
  • 电话号码:57564 +43 1 91021
  • 邮箱:office@viros.at

研究联系人备份

  • 姓名:Oliver Findl, Prim. Prof. Dr.
  • 电话号码:57564 +43 1 91021
  • 邮箱:office@viros.at

学习地点

      • Vienna、奥地利、1140
        • 招聘中
        • Vienna Institute for Research in Ocular Surgery
        • 接触:
          • Johannes Zeilinger, MD
          • 电话号码:57564 +43 1 91021
          • 邮箱:office@viros.at
        • 接触:
          • Oliver Findl, Prim. Prof. Dr.
          • 电话号码:57564 +43 1 91021
          • 邮箱:office@viros.at

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

21年 至 105年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Bilateral age-related cataract scheduled for cataract surgery
  • Age 21 or older
  • Predefined postoperative residual astigmatism to be < 0.5 D (calculated with Barrett total K toric calculator)
  • Calculated IOL power within the range of the investigated IOL
  • Pupil size ≥ 5 mm (in mydriasis)
  • Willingness to comply with the postoperative follow-up examination schedule
  • Written informed consent prior to surgery

Exclusion Criteria:

  • Previous ocular surgery or trauma
  • Extreme shallow anterior chamber
  • Uncontrolled systemic or ocular disease
  • Associated corneal pathologies (e.g., edema, scarring) or relevant other ophthalmic diseases that may result in altered visual outcome or lens stability (e.g., pseudoexfoliation syndrome, floppy iris syndrome, glaucoma, retinal disease)
  • Concurrent participation in another clinical investigation
  • Pregnancy or lactation (pregnancy test will be performed in women of reproductive age)

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:不适用
  • 介入模型:单组作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Acunex Vario toric

Patient will recieve the Acunex Vario IOL during cataract surgery

The Acunex Vario toric IOL, toric EDOF IOL, will be implanted

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
IOL axis rotation
大体时间:12 monthes

The IOL axis rotation before and after cataract surgery will be analyzed with retroillumination photographs

12 monthes

次要结果测量

结果测量
措施说明
大体时间
Distance visual acuity
大体时间:12 months

Uncorrected and corrected distance visual acuity before and after cataract surgery will be determined using ETDRS-charts in a distance of 4 metres

12 months
Intermediate visual acuity
大体时间:12 months

Uncorrected and corrected intermediate visual acuity before and after cataract surgery will be determined using ETDRS-charts in a distance of 66 centimetres

12 months
Refraction
大体时间:12 months

Refraction before and after cataract surgery will be determined using trial frame glasses and Jackson cross cylinders

12 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

调查人员

  • 首席研究员:Oliver Findl, Prim. Prof. Dr.、Vienna Institute for Research in Ocular Surgery

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年3月27日

初级完成 (估计的)

2027年12月1日

研究完成 (估计的)

2028年7月1日

研究注册日期

首次提交

2026年11月3日

首先提交符合 QC 标准的

2026年11月3日

首次发布 (实际的)

2026年11月9日

研究记录更新

最后更新发布 (实际的)

2026年11月9日

上次提交的符合 QC 标准的更新

2026年11月3日

最后验证

2026年11月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • Acunex Vario toric

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

未定

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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