Assessment of Low Energy Lens Fragmentation Cataract Extraction in Patients Undergoing Cataract Surgery

Completed · Not applicable

Conditions studied: Cataract

In brief

The purpose of this research study is to evaluate the clinical outcomes of the use of low-energy segment removal with a micro-interventional irrigation/aspiration port (MICOR-304) to evacuate the lens prior to intraocular lens insertion in subjects undergoing routine cataract surgery.

Key facts

Study ID

NCT04747834

Run by

Carl Zeiss Meditec, Inc.

People needed

100

Starts

2021-01-06

Expected to finish

2022-01-24

Last updated by the study team

2024-06-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Able to understand study requirements, willing to follow study instructions and willing to return for required study follow-up visits
• Willing and able to understand and complete the informed consent document
• Subjects with a cataract grade of 1 to 3+ and are scheduled to undergo cataract surgery
• Subjects ≥ 18 years of age
• Clear intraocular media, other than cataract

You may not qualify if…

• Polar cataracts
• Zonular instability
• History of dry eye treatments/devices and or dry eye medications other than artificial tears.
• Concurrent participation or participation in any clinical trial up to 30 days prior to preoperative visit
• Subjects that are pregnant, lactating or planning to become pregnant during the course of the study

Where it is running

• Young H. Choi Eye Surgery Center — Vestavia Hills, Alabama, United States
• Argus Research at Cape Coral Eye Center — Cape Coral, Florida, United States
• Chu Vision Institute — Bloomington, Minnesota, United States

Full record on ClinicalTrials.gov

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