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

NCT04747834 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2024-06-06

Study results available
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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 prior to intraocular lens insertion in subjects undergoing routine cataract surgery.

Conditions

  • Cataract

Interventions

DEVICE

MICOR-304

The MICOR-304 offers a mechanical approach to lens fragmentation and aspiration which provides an alternative to phacoemulsification with no cavitation, no thermogenic energy in the eye, which can eliminate generation of heat inside the eye while maintaining the same minimally invasive surgical approach through a small clear-cornea 2.5 mm incision.

Sponsors & Collaborators

  • Carl Zeiss Meditec, Inc.

    lead INDUSTRY

Principal Investigators

  • Farrell C. Tyson, M.D. · Argus Research at Cape Coral Eye Center

  • Young H. Choi, M.D. · Young H Choi Eye Surgery Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-01-06
Primary Completion
2022-01-24
Completion
2022-01-24
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04747834 on ClinicalTrials.gov