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

A Prospective Multicenter Study to Assess The Clinical Outcomes of Low Energy Lens Fragmentation Cataract Extraction in Patients Undergoing Cataract Surgery

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.

Study Overview

• Status: Completed
• Conditions: Cataract
• Intervention / Treatment: Device: MICOR-304

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 subject will be enrolled into the study. This is multicenter, multi-cohort, prospective clinical study designed to provide longitudinal, observational, non-comparative clinical outcome data for 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.

Participants who meet the inclusion and exclusion will be asked to enroll in the study. The investigator or designee will explain the study purpose, procedures and responsibilities to the potential participant and provide sufficient opportunity to ask questions, while allowing adequate time for consideration of the information provided. Upon participant confirmation of interest, written informed consent will be obtained and the subject will be enrolled in the study. One copy of the informed consent document (ICD) will be retained with the subject's medical records and one copy will be provided to the subject.

Study 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+).

Subjects will be seen at the screening visit, intraoperative visit, and at post-operative days 1, 7, and 30.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Vestavia Hills, Alabama, United States, 35243
      • Young H. Choi Eye Surgery Center
  • Florida
    • Cape Coral, Florida, United States, 33904
      • Argus Research at Cape Coral Eye Center
  • Minnesota
    • Bloomington, Minnesota, United States, 55420
      • Chu Vision Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Cohort 1; 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; 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.
Active Comparator: Cohort 2; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Surgical Procedure Time	Total Surgical Procedure Time time is defined as the beginning time when the surgeon makes the first incision in the eye and completion time is when the eye speculum is removed at the end of the procedure. Total surgical procedure time is recorded in minutes and seconds.	Assessed during the surgical procedure.
UCVA at 1-Day	Assessment of subjects uncorrected visual acuity (UCVA) at day 1 postoperative. Visual acuity is assessed by the healthcare provider without the aid of glasses or spectacles.	Postoperative 1 Day
BCDVA at 1 Week	Assessment of best-corrected distance visual acuity (BCDVA) at the 1-week postoperative visit. BCDVA is assessed by the healthcare provider and is a measurement of how well someone can see at 6m with corrective lenses, such as glasses or contact lenses.	1- week postoperative
BCDVA at 1 Month	Assessment of BCDVA at the 1 Month postoperative visit	1 month postoperative
Change in Corneal Thickness	Assessment in the mean change in corneal thickness from baseline exam through the end of the study. Corneal thickness is measured using pachymetry presented with unit of measure "μm".	Measured at Baseline, 1 Day, 1 Week and 1 Month postoperative.
Corneal Edema	Corneal edema will be assessed as the following: 0=None, 1+=Mild, 2+=Moderate and 3+=Severe	Pre-operative
Corneal Edema 1 Day Postoperative	Corneal edema will be assessed as the following: 0=None, 1+=Mild, 2+=Moderate, 3+=Severe	1 Day Postoperative
Corneal Edema 1-Week Postoperative	Corneal edema will be assessed as the following: 0=None, 1+=Mild, 2+=Moderate, 3+=Severe	1-Week Postoperative
Corneal Edema 1 Month Postoperative	Corneal edema will be assessed as the following: 0=None, 1+=Mild, 2+=Moderate and 3+=Severe	1 Month Postoperative
Corneal Cells	Corneal cells will be assessed as the following: 0=>1 cell, 0.5+=1-5 cells, 1+=6-15 cells, 2+=16-25 cells, 3+=26-50 cells and 4+=>50 cells.	Pre-operative
Corneal Cells	Corneal cells will be assessed as the following: 0=>1 cell, 0.5+=1-5 cells, 1+=6-15 cells, 2+=16-25 cells, 3+=26-50 cells and 4+=>50 cells	1 Day Postoperative
Corneal Cells	Corneal cells will be assessed as the following: 0=>1 cell, 0.5+=1-5 cells, 1+=6-15 cells, 2+=16-25 cells, 3+=26-50 cells and 4+=>50 cells	1-Week Postoperative
Corneal Cells	Corneal cells will be assessed as the following: 0=>1 cell, 0.5+=1-5 cells, 1+=6-15 cells, 2+=16-25 cells, 3+=26-50 cells and 4+=>50 cells	1-Month Postoperative
Anterior Chamber Flare	Anterior chamber flare will be assessed as the following: 0-None, 1+=Faint, 2+=Moderate, (iris and lens details clear), 3+=Marked (iris and lens details hazy), 4+=Intense fibrin or plastic aqueous.	Pre-operative
Anterior Chamber Flare	Anterior chamber flare will be assessed as the following: 0-None, 1+=Faint, 2+=Moderate, (iris and lens details clear), 3+=Marked (iris and lens details hazy), 4+=Intense fibrin or plastic aqueous.	1-Day Postoperative
Anterior Chamber Flare	Anterior chamber flare will be assessed as the following: 0-None, 1+=Faint, 2+=Moderate, (iris and lens details clear), 3+=Marked (iris and lens details hazy), 4+=Intense fibrin or plastic aqueous.	1-Week Postoperative
Anterior Chamber Flare	Anterior chamber flare will be assessed as the following: 0-None, 1+=Faint, 2+=Moderate, (iris and lens details clear), 3+=Marked (iris and lens details hazy), 4+=Intense fibrin or plastic aqueous.	1-Month Postoperative
Posterior Capsule Opacification	Posterior capsule opacification will be assessed as the following: none, minimal, mild, moderate and severe.	Pre-operative
Posterior Capsule Opacification	Posterior capsule opacification will be assessed as the following: none, minimal, mild, moderate and severe.	1-Day Postoperative
Posterior Capsule Opacificaiton	Posterior capsule opacification will be assessed as the following: none, minimal, mild, moderate and severe.	1-Week Postoperative
Posterior Capsule Opacification	Posterior capsule opacification will be assessed as the following: none, minimal, mild, moderate and severe.	1-Month Postoperative
Corneal Staining Erosion	Corneal staining erosion will be assessed as the following: 0=None, 1+=Mild, 2+=Moderate and 3=Severe	Pre-operative
Corneal Staining Erosion	Corneal staining erosion will be assessed as the following: 0=None, 1+=Mild, 2+=Moderate and 3=Severe	1-Day Postoperative
Corneal Staining Erosion	Corneal staining erosion will be assessed as the following: 0=None, 1+=Mild, 2+=Moderate and 3=Severe	1-Week Postoperative
Corneal Staining Erosion	Corneal staining erosion will be assessed as the following: 0=None, 1+=Mild, 2+=Moderate and 3=Severe	1-Month Postoperative
Other Slit-Lamp Findings	Assessment of other slit-lamp exam findings not listed on data collection form.	Preoperative
Other Slit-Lamp Findings	Assessment of other slit-lamp exam findings not listed on data collection form.	1-Day Postoperative
Other Slit-Lamp Findings	Assessment of other slit-lamp exam findings not listed on data collection form.	1-Week Postoperative
Other Slit-Lamp Findings	Assessment of other slit-lamp exam findings not listed on data collection form.	1-Month Postoperative
Macula	Macula is assessed as normal and abnormal with free text to specify if abnormal, assessed via dilated fundus examination.	Pre-operative
Macula	Macula is assessed as normal and abnormal with free text to specify if abnormal, assessed via dilated fundus examination.	1-Month Postoperative
Disc Appearance	Disc appearance is assessed as normal and abnormal with free text to specify if abnormal, assessed via dilated fundus examination.	Pre-operative
Disc Appearance	Disc appearance is assessed as normal and abnormal with free text to specify if abnormal, assessed via dilated fundus examination.	1-Month Postoperative
Vessels	Vessels are assessed as normal and abnormal with free text to specify if abnormal, assessed via dilated fundus examination.	Pre-operative
Vessels	Vessels are assessed as normal and abnormal with free text to specify if abnormal, assessed via dilated fundus examination.	1-Month Postoperative
Periphery	Periphery is assessed as normal and abnormal with free text to specify if abnormal, assessed via dilated fundus examination.	Pre-operative
Periphery	Periphery is assessed as normal and abnormal with free text to specify if abnormal, assessed via dilated fundus examination.	1-Month Postoperative

Collaborators and Investigators

• Sponsor: Carl Zeiss Meditec, Inc.
• Collaborators: Carl Zeiss Meditec Cataract Technology, Inc.
• Investigators: Principal Investigator: 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

Study record dates

Study Major Dates

• Study Start (Actual): January 6, 2021
• Primary Completion (Actual): January 24, 2022
• Study Completion (Actual): January 24, 2022

Study Registration Dates

• First Submitted: February 2, 2021
• First Submitted That Met QC Criteria: February 5, 2021
• First Posted (Actual): February 10, 2021

Study Record Updates

• Last Update Posted (Actual): June 6, 2024
• Last Update Submitted That Met QC Criteria: June 4, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: MICOR-304-101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes