Ignite Creation Date:
2024-05-06 @ 3:45 PM
Last Modification Date:
2024-10-26 @ 1:56 PM
Study NCT ID:
NCT04747834
Status:
COMPLETED
Last Update Posted:
2024-06-06
First Post:
2021-02-02
Brief Title:
Assessment of Low Energy Lens Fragmentation Cataract Extraction in Patients Undergoing Cataract Surgery
Sponsor:
Carl Zeiss Meditec Inc
Organization:
Carl Zeiss Meditec Inc
Study Overview
Official Title:
A Prospective Multicenter Study to Assess The Clinical Outcomes of Low Energy Lens Fragmentation Cataract Extraction in Patients Undergoing Cataract Surgery
Status:
COMPLETED
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 irrigationaspiration 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 irrigationaspiration 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 subjects 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
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 subjects 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None