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

Not Applicable

Completed

Conditions: Cataract

Interventions: Device: MICOR-304

Registration Number: NCT04747834

Lead Sponsor: Carl Zeiss Meditec, Inc.

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.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 100

Inclusion Criteria

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 Criteria

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort 2	MICOR-304	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..
Cohort 1	MICOR-304	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.

Primary Outcome Measures

Name	Time	Method
Total Lens Removal Time	Assessed during the surgical procedure, measured in seconds.	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.
Amount of Irrigation Solution Fluid Volume Used During the Surgical Procedure	Assessed during the surgical procedure, approximately 8 - 10 minutes.	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.

Secondary Outcome Measures

Name	Time	Method
Posterior Capsule Opacificaiton	1-Week Postoperative	Posterior capsule opacification will be assessed as the following: none, minimal, mild, moderate and severe.
Corneal Edema 1 Day Postoperative	1 Day Postoperative	Corneal edema will be assessed as the following: 0=None, 1+=Mild, 2+=Moderate, 3+=Severe
Corneal Edema 1-Week Postoperative	1-Week Postoperative	Corneal edema will be assessed as the following: 0=None, 1+=Mild, 2+=Moderate, 3+=Severe
Posterior Capsule Opacification	1-Month Postoperative	Posterior capsule opacification will be assessed as the following: none, minimal, mild, moderate and severe.
BCDVA at 1 Week	1- week postoperative	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.
Change in Corneal Thickness	Measured at Baseline, 1 Day, 1 Week and 1 Month postoperative.	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".
Corneal Edema 1 Month Postoperative	1 Month Postoperative	Corneal edema will be assessed as the following: 0=None, 1+=Mild, 2+=Moderate and 3+=Severe
BCDVA at 1 Month	1 month postoperative	Assessment of BCDVA at the 1 Month postoperative visit
Corneal Edema	Pre-operative	Corneal edema will be assessed as the following: 0=None, 1+=Mild, 2+=Moderate and 3+=Severe
Periphery	1-Month Postoperative	Periphery is assessed as normal and abnormal with free text to specify if abnormal, assessed via dilated fundus examination.
Total Surgical Procedure Time	Assessed during the surgical procedure.	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.
Anterior Chamber Flare	1-Month Postoperative	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.
Other Slit-Lamp Findings	1-Month Postoperative	Assessment of other slit-lamp exam findings not listed on data collection form.
Vessels	1-Month Postoperative	Vessels are assessed as normal and abnormal with free text to specify if abnormal, assessed via dilated fundus examination.
UCVA at 1-Day	Postoperative 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.
Corneal Cells	1-Month Postoperative	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
Corneal Staining Erosion	1-Month Postoperative	Corneal staining erosion will be assessed as the following: 0=None, 1+=Mild, 2+=Moderate and 3=Severe
Macula	1-Month Postoperative	Macula is assessed as normal and abnormal with free text to specify if abnormal, assessed via dilated fundus examination.
Disc Appearance	1-Month Postoperative	Disc appearance is assessed as normal and abnormal with free text to specify if abnormal, assessed via dilated fundus examination.

Trial Locations

Locations (3): Chu Vision Institute
🇺🇸
Bloomington, Minnesota, United States
Young H. Choi Eye Surgery Center
🇺🇸
Vestavia Hills, Alabama, United States
Argus Research at Cape Coral Eye Center
🇺🇸
Cape Coral, Florida, United States