Prospective, multicenter, single-arm, open study for post market clinical follow-up and evaluation of safety and performance of MORCHER® Capsular Rings during clinical routine - MORCHER® Capsular Rings / PMCF Study 2018

MORCHER® GmbH0 个研究点目标入组 37 人开始时间: 2019年5月20日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•1. The Patient receives cataract surgery of one or both eyes.
•2. The Patient receives a MORCHER® Capsular Ring according to the Instruction for Use (IFU).
•3. The Patient has freely given his consent in written form to take part in the study, that is to use patient´s clinical data within the study.
•4. The Patient is willing and able to take part in control examinations at the study site. The patient has been informed that participation in the control examinations at the study site is voluntary.
•5. The corresponding eye receives cataract surgery and a MORCHER® Capsular Ring according to the IFU.
•6. The corresponding eye has one of the following indications:
•High myopia
•Additional indications only for capsular tension rings and Cionni rings
•With zonulolysis
•In pseudoexfoliation
•Primary zonular weakness
•Defective or missing zonules
•Additional indications only for capsular tension rings
•Marchesani syndrome
•Additional indications only for Cionni rings
•Secondary zonular weakness (e.g. Marfans’s syndrome)

•1. The patient and/or the corresponding eye has a contraindication according to the IFU.
•2. The eyes of the patient are not fully developed and/or the patient is younger than 18 years.
•3. The MORCHER® Capsular Ring is used „off label (sometimes referred to as „compassionate use), that is beyond of its intended use.
•4. The patient is vulnerable.
•5. The patient participates in one or several interventional studies.

发起方

MORCHER® GmbH