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Device

Group 1 Phaco Subject Cohort for Cataract Surgery

N/A
Waitlist Available
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 4+ and are scheduled to undergo cataract surgery.
Subjects ≥ 18 years of age.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up all adverse events will be followed for 1 month
Awards & highlights

Study Summary

This trial compares two ways of cataract surgery: using high-frequency energy and a device with low-energy and a micro port to remove the lens.

Who is the study for?
This trial is for adults over 18 with cataract grades 1 to 4+ who are scheduled for surgery. Participants must understand the study, follow instructions, and attend follow-up visits. Those with compromised eyes or undergoing other eye surgeries, pregnant women, or those in another trial within the last month can't join.Check my eligibility
What is being tested?
The study compares traditional phacoemulsification using high-frequency energy for cataract removal against a new MICOR System device that uses low-energy and a special port to remove the lens during routine cataract surgery.See study design
What are the potential side effects?
While specific side effects aren't listed here, typical risks may include discomfort at the surgical site, inflammation, infection risk post-surgery, visual disturbances like blurriness or glare, and rare cases of more serious complications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have a cataract graded between 1 to 4+ and will have surgery for it.
Select...
I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~all adverse events will be followed for 1 month
This trial's timeline: 3 weeks for screening, Varies for treatment, and all adverse events will be followed for 1 month for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
UCVA Measurement
Other outcome measures
Rate of intraoperative and postoperative adverse events.

Trial Design

3Treatment groups
Active Control
Group I: Group 1 Phaco Subject CohortActive Control1 Intervention
The Group 1 Phaco subject cohort will begin enrolling subjects sequentially in the first initial arm of the study with up to 250 eyes total.
Group II: Group 2 miCOR System Subject CohortActive Control1 Intervention
The Group 2 MICOR System subject cohort, non-use of miLOOP will enroll subsequently with up to 250 eyes total.
Group III: Group 3 miCOR System Subject CohortActive Control1 Intervention
The Group 3 MICOR System subject cohort, use of miLOOP optional will enroll subsequently with up to 250 eyes total.

Find a Location

Who is running the clinical trial?

Carl Zeiss Meditec, Inc.Lead Sponsor
22 Previous Clinical Trials
5,275 Total Patients Enrolled

Frequently Asked Questions

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

Does this clinical trial currently have open enrollment for participants?

"Clinicaltrials.gov indicates that this medical study, which began accepting participants on December 6th 2022 is no longer recruiting. Nonetheless, 131 other trials are currently seeking recruits to participate in the clinical trial process."

Answered by AI

In what number of medical facilities is this trial being conducted currently?

"Six institutes are offering this research opportunity, including Mittleman Eye in West Palm Beach, Wolfe Eye Clinic in Hiawatha and Penn State Health's Eye Center situated in Hershey. Additionally, there are three other centers participating as well."

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

Why did patients apply to this trial?

Need cataract surgery with astigmatism cannot afford surgery.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
A Prospective Multicenter Study To Assess The Clinical Outcomes Of Current Phacoemulsification Approach To Cataract Extraction Versus The Micor System Device
2022. "A Prospective Multicenter Study To Assess The Clinical Outcomes Of Current Phacoemulsification Approach To Cataract Extraction Versus The Micor System Device". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05729477.
All > Cataract
~161 spots leftby Apr 2025
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