Status:
COMPLETED
Assessment of Low Energy Lens Fragmentation Cataract Extraction in Patients Undergoing Cataract Surgery
Lead Sponsor:
Carl Zeiss Meditec, Inc.
Conditions:
Cataract
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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...
Detailed Description
Up to 300 eyes at up to 5 investigational sites will be enrolled in one of the two cohorts of this clinical investigation - up to 50 eyes in Cohort 1 and up to 50 eyes in Cohort 2. Only one eye per su...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
January 6 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 24 2022
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04747834
Start Date
January 6 2021
End Date
January 24 2022
Last Update
June 6 2024
Active Locations (3)
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1
Young H. Choi Eye Surgery Center
Vestavia Hills, Alabama, United States, 35243
2
Argus Research at Cape Coral Eye Center
Cape Coral, Florida, United States, 33904
3
Chu Vision Institute
Bloomington, Minnesota, United States, 55420