跳至主要内容
临床试验/NCT05912829
NCT05912829招募中不适用

Evaluation of Two Different Intraocular Lens Models After Lens Implantation Using the Yamane Technique

Johannes Kepler University of Linz2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2023年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
50
试验地点
2
主要终点
uncorrected visual acuity

研究概览

简要总结

In case of instability or rupture of capsular bag occurs during cataract surgery, Yamane technique is one of the options to fix intracocularlens' haptics. Yamane technique uses a double-needle technique that seamlessly fixes the haptics intrascleral by creating a scleral tunnel.

Aberrations, IOL tilting or even dislocations might occur and influence the final outcome of IOL implantation.

The aim of this study is the evaluation of the postoperative tilt of Kowa PU6AS using Yamane technique. Furthermore of the corrected and uncorrected visual acuity and the anterior chamber depth are being developed.

详细描述

During uncomplicated cataract surgery, an intraocular lens (IOL) is implanted into the patient's capsular bag. If increased instability or rupture of this capsular bag occurs due to aggravated intraoperative conditions or IOL dislocation, several options are available to the surgeon to correct the aphakia, all characterized by their respective advantages and disadvantages, but with no clear superiority of any one method.

The popular Yamane technique, or "flanged IOL fixation", uses a double-needle technique that seamlessly fixes the haptics intrascleral by creating a scleral tunnel using two 30-gauge needles.

Examples of lenses used for this purpose are the TECNIS ZA9003 (Johnson&Johnson, USA) and the Kowa PU6AS (Kowa, Japan). Another approach is the Carlevale FIL-SSF IOL (Soleko, Italy), which was developed specifically for use in aphakia with lack of capsular stability.

All types of implantation are not immune to aberrations, tilting or even dislocation. Many factors influence the final outcome of IOL implantation, be it the optimal choice of intraocular lens power, the surgeon's experience regarding fixation in more challenging eyes, or individual anatomical conditions. As part of quality assurance, an evaluation of monthly and six-monthly data will now be performed. The aim of this study is the evaluation of the postoperative tilt of the Kowa PU6AS in Yamane technique, as well as the evaluation of the corrected and uncorrected visual acuity and the anterior chamber depth within the clinical quality management.

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
21 Years 至 110 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Minimum age: 21 Years
  • planned or performed lens implantation using the Kowa PU6AS or the Johnson & Johnson ZA9003 using the Yamane technique
  • signed patient consent form

排除标准

  • best corrected visual acuity >0.1 (Snellen)
  • pregnancy

结局指标

主要结局

uncorrected visual acuity

时间窗: 6 Weeks

Measurement performed by experienced staff

Tilt

时间窗: 6 Weeks

Postoperative Tilt

Autorefraction

时间窗: 6 Weeks

Refraction using an automated refractor

Subjective Refraction

时间窗: 6 Weeks

Refraction performed by experienced staff

Best corrected visual acuity

时间窗: 6 Weeks

Measurement performed by experienced staff

次要结局

未报告次要终点

研究者

发起方
Johannes Kepler University of Linz
申办方类型
Other
责任方
Sponsor

研究点 (2)

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