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

Cataract Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04747834
• Other study ID #: MICOR-304-101
• Status: Enrolling by invitation
• Phase: N/A
• Start date: January 6, 2021
• Est. completion date: December 2025

Study information

• Verified date: January 2024
• Source: Carl Zeiss Meditec, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 300
• Est. completion date: December 2025
• Est. primary completion date: November 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cataract

Intervention

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.

Locations

Country	Name	City	State
United States	Chu Vision Institute	Bloomington	Minnesota
United States	Argus Research at Cape Coral Eye Center	Cape Coral	Florida
United States	Young H. Choi Eye Surgery Center	Vestavia Hills	Alabama

Sponsors (2)

Lead Sponsor	Collaborator
Carl Zeiss Meditec, Inc.	Carl Zeiss Meditec Cataract Technology, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.; o 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.
Primary	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.
Secondary	Uncorrected Visual Acuity	Assessment of Uncorrected Visual Acuity.	Postoperative days 1, 7, and 30.
Secondary	Change in corneal thickness	Assessment in change in corneal thickness from baseline through end of study.	Baseline through 30 days postoperative.
Secondary	Rate of occurrence of intraoperative and postoperative adverse events	Assessment of intraoperative and postoperative adverse events.	From study enrollment through study completion at 1 month postoperative.
Secondary	Corneal Edema	Corneal edema will be assessed as the following: 0=None, 1+=Mild, 2+=Moderate and 3+=Severe assessed via slit-lamp.	Pre-operative, 1-day, 1-week and 1-month postoperative study completion.
Secondary	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 assessed via slit-lamp.	Pre-operative, 1-day, 1-week and 1-month postoperative study completion.
Secondary	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 assessed via slit-lamp.	Pre-operative, 1-day, 1-week and 1-month postoperative study completion.
Secondary	Posterior Capsule Opacification	Posterior capsule opacification will be assessed as the following: none, minimal, mild, moderate and severe assessed via slit-lamp.	Pre-operative, 1-day, 1-week and 1-month postoperative study completion.
Secondary	Corneal Staining Erosion	Corneal staining erosion will be assessed as the following: 0=None, 1+=Mild, 2+=Moderate and 3=Severe assessed via slit-lamp.	Pre-operative, 1-day, 1-week and 1-month postoperative study completion.
Secondary	Disc Appearance	Disc appearance is assessed as normal and abnormal with free text to specify if abnormal, assessed via dilated fundus examination.	Pre-operative and 1-month postoperative study completion.
Secondary	Macula	Macula is assessed as normal and abnormal with free text to specify if abnormal, assessed via dilated fundus examination.	Pre-operative and 1-month postoperative study completion.
Secondary	Vessels	Vessels are assessed as normal and abnormal with free text to specify if abnormal, assessed via dilated fundus examination.	Pre-operative and 1-month postoperative study completion.
Secondary	Periphery	Periphery is assessed as normal and abnormal with free text to specify if abnormal, assessed via dilated fundus examination.	Pre-operative and 1-month postoperative study completion.
Secondary	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.