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

NCT04747834 | Completed Results FDA Device

• 1 other identifier: MICOR-304-101
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 3

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

Conditions

Cataract

Outcome Measures

Primary Outcomes (2)

• Total Lens Removal Time

  Total lens removal time is defined in two phases: * The beginning time starts when the surgeon enters the eye with the MICOR-304 to start the lens removal process and completing when the surgeon finishes the nucleus lens removal with the MICOR-304 before changing over to irrigation and aspiration. * The second phase of lens removal time is the irrigation and aspiration stage for cortex removal which starts when the irrigation and aspiration tip enters the eye and completion time is when the cortex is removed. The total lens removal time as defined above is recorded in minutes and seconds.

  Assessed during the surgical procedure, measured in seconds.

• Amount of Irrigation Solution Fluid Volume Used During the Surgical Procedure

  Total irrigation solution volume will be recorded using the indicators on the bag which will have labels that have pre-defined markers to indicate milliliters (ml) of volume of irrigation solution used for the surgical procedure.

  Assessed during the surgical procedure, approximately 8 - 10 minutes.

Secondary Outcomes (37)

• Total Surgical Procedure Time

  Assessed during the surgical procedure.

• UCVA at 1-Day

  Postoperative 1 Day

• BCDVA at 1 Week

  1- week postoperative

• BCDVA at 1 Month

  1 month postoperative

• Change in Corneal Thickness

  Measured at Baseline, 1 Day, 1 Week and 1 Month postoperative.

Study Arms (2)

Cohort 1

ACTIVE COMPARATOR

Subjects with mild to moderate cataracts (Grade 1 to 2) scheduled to undergo mechanical non-phacoemulsification lens extraction using low-energy segment removal with a micro-interventional irrigation/aspiration port (MICOR-304) to evacuate the lens prior to intraocular lens insertion.

Device: MICOR-304

Cohort 2

ACTIVE COMPARATOR

Subjects with moderate to dense cataracts (Grade 2+ to 3+) scheduled to undergo mechanical non-phacoemulsification lens extraction using low-energy segment removal with a micro-interventional irrigation/aspiration port (MICOR-304) to evacuate the lens prior to intraocular lens insertion..

Device: MICOR-304

Interventions

MICOR-304 DEVICE

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.

Cohort 1; Cohort 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Carl Zeiss Meditec, Inc.: lead

Study Sites (3)

Young H. Choi Eye Surgery Center

Vestavia Hills, Alabama, 35243, United States

Location

Argus Research at Cape Coral Eye Center

Cape Coral, Florida, 33904, United States

Location

Chu Vision Institute

Bloomington, Minnesota, 55420, United States

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Results Point of Contact

• Title: Gretchen Neumann
• Organization: Regulatory Pathways Group, Inc.

gneumann@regulatorypathways.com

19494667124

Study Officials

• Farrell C. Tyson, M.D.

  Argus Research at Cape Coral Eye Center

  PRINCIPAL INVESTIGATOR

• Young H. Choi, M.D.

  Young H Choi Eye Surgery Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Subjects will be stratified into two Cohorts. Cohort 1 is comprised of eyes with mild-to- moderate cataracts only (Grade 1 to 2). Cohort 2 is comprised of eyes with moderate to more dense cataracts only (Grade 2+ to 3+).

Study Record Dates

• First Submitted: February 2, 2021
• First Posted: February 10, 2021
• Study Start: January 6, 2021
• Primary Completion: January 24, 2022
• Study Completion: January 24, 2022
• Last Updated: June 6, 2024
• Results First Posted: June 6, 2024

Record last verified: 2024-06

Locations

US (3)