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

Carl Zeiss Meditec

Status: Completed

Conditions: Cataract

Treatments: Device: MICOR-304

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT04747834

MICOR-304-101

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Cohort 1

Active Comparator group

Description:

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.

Treatment:

Device: MICOR-304

Cohort 2

Active Comparator group

Description:

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..

Treatment:

Device: MICOR-304