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

• Conditions: H28; Cataract and other disorders of lens in diseases classified elsewhere

• Registration Number: DRKS00015295
• Lead Sponsor: MORCHER® GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-05-20
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting stopped after recruiting started
• Sex: All
• Target Recruitment: 37

Inclusion Criteria

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)

Exclusion Criteria

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.

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Assessment of centering of the intraocular lens after cataract surgery

Secondary Outcome Measures

Name	Time	Method
1) Assessment of Tension folds within the capsular bag, <br>2) Documentation of tretament-associated adverse Events