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Device

Low Energy Lens Fragmentation for Cataract Surgery

N/A
Waitlist Available
Led By Farrell C. Tyson, M.D.
Research Sponsored by Carl Zeiss Meditec, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subjects with a cataract grade of 1 to 3+ and are scheduled to undergo cataract surgery
Subjects ≥ 18 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre-operative and 1-month postoperative study completion.
Awards & highlights

Study Summary

This trial studies how removing a cloudy lens during cataract surgery can improve intraocular lens insertion.

Who is the study for?
This trial is for adults over 18 with mild to moderate cataracts who understand the study and can follow instructions. They must be scheduled for cataract surgery, not pregnant, nor have participated in another clinical trial within the last month. People with unstable eye structures or severe dry eye conditions are excluded.Check my eligibility
What is being tested?
The study is testing a new method called MICOR-304 which uses low-energy to remove lens fragments during routine cataract surgery before placing a new intraocular lens.See study design
What are the potential side effects?
While specific side effects of MICOR-304 aren't detailed, typical risks may include inflammation, infection, bleeding inside the eye, increased eye pressure, or retinal detachment associated with standard cataract procedures.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have a mild to moderate cataract and am scheduled for surgery.
Select...
I am 18 years old or older.
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My eyes are clear of any issues except for cataracts.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre-operative and 1-month postoperative study completion.
This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-operative and 1-month postoperative study completion. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Amount of irrigation solution fluid volume used during the surgical procedure
Total lens removal time
Secondary outcome measures
Anterior Chamber Flare
Change in corneal thickness
Corneal Cells
+10 more

Trial Design

2Treatment groups
Active Control
Group I: Cohort 1Active Control1 Intervention
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.
Group II: Cohort 2Active Control1 Intervention
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..

Find a Location

Who is running the clinical trial?

Carl Zeiss Meditec, Inc.Lead Sponsor
22 Previous Clinical Trials
5,350 Total Patients Enrolled
2 Trials studying Cataract
411 Patients Enrolled for Cataract
Carl Zeiss Meditec Cataract Technology, Inc.UNKNOWN
Farrell C. Tyson, M.D.Principal InvestigatorArgus Research at Cape Coral Eye Center

Media Library

MICOR-304 (Device) Clinical Trial Eligibility Overview. Trial Name: NCT04747834 — N/A
Cataract Research Study Groups: Cohort 1, Cohort 2
Cataract Clinical Trial 2023: MICOR-304 Highlights & Side Effects. Trial Name: NCT04747834 — N/A
MICOR-304 (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04747834 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there any remaining capacity to enroll participants in this experiment?

"According to the clinicaltrials.gov website, this study is not currently welcoming new participants. This trial was first posted on June 1st 2021 and last edited February 13th 2023; however, there are 131 other medical trials actively searching for enrollees at present."

Answered by AI

What is the underlying goal of this experimental endeavor?

"The central aim of this medical research is to measure the amount of irrigation solution fluid volume used during a specific surgical procedure. Secondary objectives include gauging changes in corneal thickness, assessing intraoperative and postoperative adverse events, as well as measuring corneal edema intensity via slit-lamp examination over the course of the trial."

Answered by AI

Who else is applying?

What state do they live in?
Florida
What site did they apply to?
Argus Research at Cape Coral Eye Center
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
Recent research and studies
clinicaltrials.govStudy
Assessment of Low Energy Lens Fragmentation Cataract Extraction in Patients Undergoing Cataract Surgery
2021. "Assessment of Low Energy Lens Fragmentation Cataract Extraction in Patients Undergoing Cataract Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04747834.
All > Cataract
~95 spots leftby Nov 2025
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