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临床试验/NCT05779306
NCT05779306已完成不适用

Performance of Two Sclera Fixated Intraocular Lens Concepts

Johannes Kepler University of Linz1 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2023年1月19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
26
试验地点
1
主要终点
Best corrected visual acuity

研究概览

简要总结

To evaluate and compare the post-operative outcome of two different sceral fixated IOL concepts, the Yamane method (ZA9003, J&J, USA) and the Carlevale IOL (FIL-SSF, Soleko, Italy).

详细描述

Various approaches to fix the haptics in the sclera can be found in literature. A distinction can be made between suture-fixed and sutureless techniques. The former often proves to be technically challenging and complicated, which has led to an increased rethinking towards sutureless implantation in recent years.

The popular Yamane technique or "flanged IOL fixation" uses a double-needle technique that creates a scleral tunnel and fixates the haptics seamlessly using two 30-gauge needles. However, the haptics must be bent for this purpose Thus, this method is not ideal, since besides from the high degree of manipulation necessary for implantation of the IOL, it is also prone to dislocation and tilt.

A more recent approach is the Carlevale FIL-SSF IOL (Soleko, Italy), which was developed specifically for use in aphakia with a lack of capsular stability. Using two t-shaped anchors, the lens is positioned in two scleral flaps at 180 degrees to each other, without the preparation of a tunnel or excessive manipulation of the haptics. These two self-blocking anchors also provide a great deal of stability. The extent of abberations is also much less with this type of lens implantation, as the fixed position reduces the risk of them. Thus, the Carlevale technique represents a new, potentially superior option for intrascleral fixation.

However, all these types of implantation are not free from aberrations, tilt, or even dislocation. Many factors influence the outcome of IOL implantation, 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 management, an evaluation of monthly and six-monthly data will be performed. The aim of this study is the evaluation of the postoperative tilt of the Carlevale lens, as well as the evaluation of the corrected and uncorrected visual acuity and the anterior chamber depth within the clinical quality management. Patients who have already undergone surgery are called to our clinic by telephone at the earliest 6 weeks after surgery for a one-time follow-up appointment.

The collected data is then evaluated and analyzed as well as compared to the Yamane data.

研究设计

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

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 of 21 years
  • planned surgery or already taken place surgery using a scleral fixated lens

排除标准

  • best corrected visual acuity <0.05 Snellen
  • pregnancy
  • missing informed consent form

结局指标

主要结局

Best corrected visual acuity

时间窗: 6 Weeks

Measurement performed by experienced staff

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

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 (1)

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