Clinical trial NCT04747834: Assessment of Low Energy Lens Fragmentation Cataract Extraction in Patients Undergoing Cataract Surgery
Official title: A Prospective Multicenter Study to Assess The Clinical Outcomes of Low Energy Lens Fragmentation Cataract Extraction in Patients Undergoing Cataract Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract
Lead sponsor: Carl Zeiss Meditec, Inc.
Sponsor class: INDUSTRY
First posted: 2021-02-10
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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+).
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Total Lens Removal Time
timeFrame: Assessed during the surgical procedure, measured in seconds.
measure: Amount of Irrigation Solution Fluid Volume Used During the Surgical Procedure
timeFrame: Assessed during the surgical procedure, approximately 8 - 10 minutes.
Secondary outcomes:
measure: Total Surgical Procedure Time
timeFrame: Assessed during the surgical procedure.
measure: UCVA at 1-Day
timeFrame: Postoperative 1 Day
measure: BCDVA at 1 Week
timeFrame: 1- week postoperative
measure: BCDVA at 1 Month
timeFrame: 1 month postoperative
measure: Change in Corneal Thickness
timeFrame: Measured at Baseline, 1 Day, 1 Week and 1 Month postoperative.
measure: Corneal Edema
timeFrame: Pre-operative
measure: Corneal Edema 1 Day Postoperative
timeFrame: 1 Day Postoperative
measure: Corneal Edema 1-Week Postoperative
timeFrame: 1-Week Postoperative
measure: Corneal Edema 1 Month Postoperative
timeFrame: 1 Month Postoperative
measure: Corneal Cells
timeFrame: Pre-operative
measure: Corneal Cells
timeFrame: 1 Day Postoperative
measure: Corneal Cells
timeFrame: 1-Week Postoperative
measure: Corneal Cells
timeFrame: 1-Month Postoperative
measure: Anterior Chamber Flare
timeFrame: Pre-operative
measure: Anterior Chamber Flare
timeFrame: 1-Day Postoperative
measure: Anterior Chamber Flare
timeFrame: 1-Week Postoperative
measure: Anterior Chamber Flare
timeFrame: 1-Month Postoperative
measure: Posterior Capsule Opacification
timeFrame: Pre-operative
measure: Posterior Capsule Opacification
timeFrame: 1-Day Postoperative
measure: Posterior Capsule Opacificaiton
timeFrame: 1-Week Postoperative
measure: Posterior Capsule Opacification
timeFrame: 1-Month Postoperative
measure: Corneal Staining Erosion
timeFrame: Pre-operative
measure: Corneal Staining Erosion
timeFrame: 1-Day Postoperative
measure: Corneal Staining Erosion
timeFrame: 1-Week Postoperative
measure: Corneal Staining Erosion
timeFrame: 1-Month Postoperative
measure: Other Slit-Lamp Findings
timeFrame: Preoperative
measure: Other Slit-Lamp Findings
timeFrame: 1-Day Postoperative
measure: Other Slit-Lamp Findings
timeFrame: 1-Week Postoperative
measure: Other Slit-Lamp Findings
timeFrame: 1-Month Postoperative
measure: Macula
timeFrame: Pre-operative
measure: Macula
timeFrame: 1-Month Postoperative
measure: Disc Appearance
timeFrame: Pre-operative
measure: Disc Appearance
timeFrame: 1-Month Postoperative
measure: Vessels
timeFrame: Pre-operative
measure: Vessels
timeFrame: 1-Month Postoperative
measure: Periphery
timeFrame: Pre-operative
measure: Periphery
timeFrame: 1-Month Postoperative
Other outcomes:
Locations:
city: Vestavia Hills
country: United States
facility: Young H. Choi Eye Surgery Center
state: Alabama
city: Cape Coral
country: United States
facility: Argus Research at Cape Coral Eye Center
state: Florida
city: Bloomington
country: United States
facility: Chu Vision Institute
state: Minnesota
Study officials:
affiliation: Argus Research at Cape Coral Eye Center
name: Farrell C. Tyson, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Young H Choi Eye Surgery Center
name: Young H. Choi, M.D.
role: PRINCIPAL_INVESTIGATOR
References: