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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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00015295
Enrollment
150
Registered
2019-05-20
Start date
2019-12-05
Completion date
Unknown
Last updated
2025-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

H25 H26

Interventions

Group 1: MORCHER Capsular Ring

Sponsors

MORCHER® GmbH
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
Assessment of centering of the intraocular lens after cataract surgery

Secondary

MeasureTime frame
1) Assessment of Tension folds within the capsular bag, 2) Documentation of tretament-associated adverse Events

Countries

Germany

Contacts

Public ContactDaniela Schilling

MORCHER GmbH

info@morcher.com+49(0)711-953-20-0

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026