Cataract SurgeryNCT05729477
A Prospective Multicenter Study To Assess The Clinical Outcomes Of Current Phacoemulsification Approach To Cataract Extraction Versus The Micor System Device
A study testing miCOR System and Phaco Subject Cohort in people with Cataract Surgery, run by Carl Zeiss Meditec, Inc. at 6 sites in United States.
Trial summary
The purpose of this research study is to evaluate the clinical outcomes of current phacoemulsification approaches to cataract extraction involving high-frequency thermogenic energy versus the use of the MICOR System device using low-energy segment removal with a micro-interventional irrigation/aspiration port to… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cataract Surgery
- What is being tested?
- miCOR System and Phaco Subject Cohort
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 402 participants
- Where
- 6 sitesUnited States
- Study dates
- 6 Dec 2022to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Able to understand study requirements, willing to follow study instructions and willing to return for required study follow-up visits.
- Willing and able to understand and complete the informed consent document.
- Subjects with a cataract grade of 1 to 4+ and are scheduled to undergo cataract surgery.
- Subjects ≥ 18 years of age.
Who cannot join
- Subjects, who in the opinion of the investigator, have "compromised" eye(s); no comorbidities and no patients undergoing concurrent corneal surgery with cataract extraction.
- Concurrent participation or participation in any clinical trial up to 30 days prior to preoperative visit.
- Subjects that are pregnant, lactating or planning to become pregnant during the course of the study.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Argus Research at Cape Coral Eye Center
Cape Coral, Florida, 33904
Penn State Health Eye Center
Hershey, Pennsylvania, 17033
Wolfe Eye Clinic
Hiawatha, Iowa, 52233
Virginia Eye Consultants
Norfolk, Virginia, 23502
The eye Centers of Racine and Kenosh
Racine, Wisconsin, 53405
Mittleman Eye
West Palm Beach, Florida, 33409
About this study
Official title: A Prospective Multicenter Study To Assess The Clinical Outcomes Of Current Phacoemulsification Approach To Cataract Extraction Versus The Micor System Device Using Low Energy Lens Extraction In Patients Undergoing Cataract Surgery
The purpose of this research study is to evaluate the clinical outcomes of current phacoemulsification approaches to cataract extraction involving high-frequency thermogenic energy versus the use of the MICOR System device using low-energy segment removal with a micro-interventional irrigation/aspiration port to evacuate the lens in subjects undergoing routine cataract surgery.
Read the detailed description
This is prospective, multicenter, 3-arm study designed to provide longitudinal, observational, clinical outcome data for the use of traditional phacoemulsification for subjects undergoing cataract surgery versus the MICOR System device used to evacuate the lens prior to intraocular lens insertion and cataract surgery. Only FDA cleared phacoemulsification devices can be used per indications.
Both eyes of the study subjects may be enrolled into the study; however, if only 1 eye is eligible for study participation, then the eligible eye of the subject may be enrolled. Up to 750 eyes will be enrolled into one of three study groups, up to 250 subjects per group, with a maximum of 10 study centers. The 3 arms of the study groups are as follows:
- Group 1 Phaco subject cohort.
- Group 2 MICOR System subject cohort, non-use of miLOOP.
- Group 3 MICOR System subject cohort, use of miLOOP optional.
- Conditions
- Cataract Surgery
- Being tested
- miCOR System, Phaco Subject Cohort
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
miCOR SystemDevice
The miCOR system is a lens fragmentation device used to break up the cataract prior to IOL implantation during cataract surgery.
Phaco Subject CohortDevice
Phaco Subject Cohort
| Study group | Role | What they receive |
|---|---|---|
| Group 1 Phaco Subject Cohort | Active comparator | 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. Receives: Device: Phaco Subject Cohort |
| Group 2 miCOR System Subject Cohort | Active comparator | The Group 2 MICOR System subject cohort, non-use of miLOOP will enroll subsequently with up to 250 eyes total. Receives: Device: miCOR System |
| Group 3 miCOR System Subject Cohort | Active comparator | The Group 3 MICOR System subject cohort, use of miLOOP optional will enroll subsequently with up to 250 eyes total. Receives: Device: miCOR System |
What is being measured
The primary outcome is the main question the study is designed to answer.
UCVA Measurement
1-Day postoperative UCVA measurement using LogMAR visual acuity charts
Measured: 1 day postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2023
- Study start6 Dec 2022
- Primary completion30 Nov 2025
- Study completion30 Dec 2025
Why it stopped: Sponsor decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cataract SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- The miCOR System used during cataract surgery is a lens fragmentation and lens removal device which is an alternative to conventional phacoemulsification. The miCOR system has no cavitation and no thermogenic energy in the eye which can eliminate the generation of heat inside the eye while at the same time maintaining the same minimally invasive surgical approach through a small clear-cornea 2.5 mm incision.
- Masking
- None (open label)
- Enrolment
- 402 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carl Zeiss Meditec, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05729477
- Sponsor's protocol ID
- MICOR-304-102
- Status last verified
- Mar 2026
- First submitted
- 8 Nov 2022
- Last updated
- 14 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Multicenter Study To Assess The Clinical Outcomes Of Current Phacoemulsification Approach To Cataract Extraction Versus The Micor System Device Using Low Energy Lens Extraction In Patients Undergoing Cataract Surgery
- ClinicalTrials.gov ID
- NCT05729477
- Acronym / sponsor ID
- MICOR-304-102
- Conditions
- Cataract Surgery
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor decision
- Enrolment
- 402 participants (actual)
- Lead sponsor
- Carl Zeiss Meditec, Inc.Industry (pharma, biotech, devices)
- Study start
- 6 Dec 2022 (actual)
- Primary completion
- 30 Nov 2025 (actual)
- Study completion
- 30 Dec 2025 (actual)
- First posted
- 15 Feb 2023 (actual)
- Results
- Posted 14 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research study is to evaluate the clinical outcomes of current phacoemulsification approaches to cataract extraction involving high-frequency thermogenic energy versus the use of the MICOR System device using low-energy segment removal with a micro-interventional irrigation/aspiration port to evacuate the lens in subjects undergoing routine cataract surgery.
Detailed description
This is prospective, multicenter, 3-arm study designed to provide longitudinal, observational, clinical outcome data for the use of traditional phacoemulsification for subjects undergoing cataract surgery versus the MICOR System device used to evacuate the lens prior to intraocular lens insertion and cataract surgery. Only FDA cleared phacoemulsification devices can be used per indications.
Both eyes of the study subjects may be enrolled into the study; however, if only 1 eye is eligible for study participation, then the eligible eye of the subject may be enrolled. Up to 750 eyes will be enrolled into one of three study groups, up to 250 subjects per group, with a maximum of 10 study centers. The 3 arms of the study groups are as follows:
- Group 1 Phaco subject cohort.
- Group 2 MICOR System subject cohort, non-use of miLOOP.
- Group 3 MICOR System subject cohort, use of miLOOP optional.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- The miCOR System used during cataract surgery is a lens fragmentation and lens removal device which is an alternative to conventional phacoemulsification. The miCOR system has no cavitation and no thermogenic energy in the eye which can eliminate the generation of heat inside the eye while at the same time maintaining the same minimally invasive surgical approach through a small clear-cornea 2.5 mm incision.
| Arm | Type | Receives |
|---|---|---|
| Group 1 Phaco Subject Cohort | Active comparator | Device: Phaco Subject CohortThe 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 2 miCOR System Subject Cohort | Active comparator | Device: miCOR SystemThe Group 2 MICOR System subject cohort, non-use of miLOOP will enroll subsequently with up to 250 eyes total. |
| Group 3 miCOR System Subject Cohort | Active comparator | Device: miCOR SystemThe Group 3 MICOR System subject cohort, use of miLOOP optional will enroll subsequently with up to 250 eyes total. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Able to understand study requirements, willing to follow study instructions and willing to return for required study follow-up visits.
- Willing and able to understand and complete the informed consent document.
- Subjects with a cataract grade of 1 to 4+ and are scheduled to undergo cataract surgery.
- Subjects ≥ 18 years of age.
Key exclusion criteria (3 listed)
- Subjects, who in the opinion of the investigator, have "compromised" eye(s); no comorbidities and no patients undergoing concurrent corneal surgery with cataract extraction.
- Concurrent participation or participation in any clinical trial up to 30 days prior to preoperative visit.
- Subjects that are pregnant, lactating or planning to become pregnant during the course of the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| miCOR SystemThe miCOR system is a lens fragmentation device used to break up the cataract prior to IOL implantation during cataract surgery. | Device | Group 2 miCOR System Subject Cohort, Group 3 miCOR System Subject Cohort |
| Phaco Subject CohortPhaco Subject Cohort | Device | Group 1 Phaco Subject Cohort |
Primary outcome
UCVA Measurement
Time frame: 1 day postoperative
1-Day postoperative UCVA measurement using LogMAR visual acuity charts
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing miCOR System and Phaco Subject Cohort in people with Cataract Surgery, run by Carl Zeiss Meditec, Inc. at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
UCVA Measurement (time frame: 1 day postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026; AzTrials last refreshed its copy on 6 Nov 2026.