Trial Outcomes & Findings for A Prospective Multicenter Study To Assess The Clinical Outcomes Of Current Phacoemulsification Approach To Cataract Extraction Versus The Micor System Device (NCT NCT05729477)
NCT ID: NCT05729477
Last Updated: 2026-05-14
Results Overview
1-Day postoperative UCVA measurement using LogMAR visual acuity charts
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
402 participants
Primary outcome timeframe
1 day postoperative
Results posted on
2026-05-14
Participant Flow
Subject recruitment began in November of 2022 thru November of 2023 at 6 clinical study sites.
Unit of analysis: Eyes
Participant milestones
| Measure |
Group 1 Phaco Subject Cohort
The Group 1 Phaco subject cohort will begin enrolling subjects sequentially in the first initial arm of the study.
|
Group 2 Micor Subject Cohort
The Group 2 Micor subject cohort will enrolling subjects subsequent to the Phaco arm of the study.
|
|---|---|---|
|
Overall Study
STARTED
|
288 449
|
114 162
|
|
Overall Study
COMPLETED
|
283 444
|
111 150
|
|
Overall Study
NOT COMPLETED
|
5 5
|
3 12
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Eyes
Baseline characteristics by cohort
| Measure |
Group 1 Phaco Subject Cohort
n=449 Eyes
The Group 1 Phaco subject cohort will begin enrolling subjects sequentially in the first initial arm of the study with up to 510 eyes total.
|
Group 3 miCOR System Subject Cohort
n=162 Eyes
The Group 3 MICOR System subject cohort, use of miLOOP optional will enroll subsequently with up to 450 eyes total.
|
Total
n=611 Eyes
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
0 Participants
n=2016 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=1512 Participants
|
13 Participants
n=504 Participants
|
27 Participants
n=2016 Participants
|
|
Age, Categorical
>=65 years
|
274 Participants
n=1512 Participants
|
101 Participants
n=504 Participants
|
375 Participants
n=2016 Participants
|
|
Sex: Female, Male
Female
|
164 Participants
n=1512 Participants
|
71 Participants
n=504 Participants
|
235 Participants
n=2016 Participants
|
|
Sex: Female, Male
Male
|
124 Participants
n=1512 Participants
|
43 Participants
n=504 Participants
|
167 Participants
n=2016 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
0 Participants
n=2016 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=1512 Participants
|
1 Participants
n=504 Participants
|
3 Participants
n=2016 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=1512 Participants
|
1 Participants
n=504 Participants
|
1 Participants
n=2016 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=1512 Participants
|
2 Participants
n=504 Participants
|
12 Participants
n=2016 Participants
|
|
Race (NIH/OMB)
White
|
263 Participants
n=1512 Participants
|
108 Participants
n=504 Participants
|
371 Participants
n=2016 Participants
|
|
Race (NIH/OMB)
More than one race
|
13 Participants
n=1512 Participants
|
2 Participants
n=504 Participants
|
15 Participants
n=2016 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
0 Participants
n=2016 Participants
|
|
Region of Enrollment
United States
|
288 Participants
n=1512 Participants
|
114 Participants
n=504 Participants
|
402 Participants
n=2016 Participants
|
|
Cataract Type
Nuclear Sclerotic :
|
407 Eyes
n=28 Eyes • Eyes
|
140 Eyes
n=60 Eyes • Eyes
|
547 Eyes
n=60 Eyes • Eyes
|
|
Cataract Type
Cortical :
|
26 Eyes
n=28 Eyes • Eyes
|
19 Eyes
n=60 Eyes • Eyes
|
45 Eyes
n=60 Eyes • Eyes
|
|
Cataract Type
Brunescent :
|
5 Eyes
n=28 Eyes • Eyes
|
0 Eyes
n=60 Eyes • Eyes
|
5 Eyes
n=60 Eyes • Eyes
|
|
Cataract Type
Posterior Subcapsular :
|
11 Eyes
n=28 Eyes • Eyes
|
3 Eyes
n=60 Eyes • Eyes
|
14 Eyes
n=60 Eyes • Eyes
|
|
Cataract Grade
1-1+ : :
|
14 Eyes
n=28 Eyes • The number of patients analyzed is different from the unit number of eyes. Each patient could have either 1 or 2 eyes enrolled into the study.
|
10 Eyes
n=60 Eyes • The number of patients analyzed is different from the unit number of eyes. Each patient could have either 1 or 2 eyes enrolled into the study.
|
24 Eyes
n=60 Eyes • The number of patients analyzed is different from the unit number of eyes. Each patient could have either 1 or 2 eyes enrolled into the study.
|
|
Cataract Grade
2-2+ : :
|
209 Eyes
n=28 Eyes • The number of patients analyzed is different from the unit number of eyes. Each patient could have either 1 or 2 eyes enrolled into the study.
|
125 Eyes
n=60 Eyes • The number of patients analyzed is different from the unit number of eyes. Each patient could have either 1 or 2 eyes enrolled into the study.
|
334 Eyes
n=60 Eyes • The number of patients analyzed is different from the unit number of eyes. Each patient could have either 1 or 2 eyes enrolled into the study.
|
|
Cataract Grade
3-3+ : :
|
211 Eyes
n=28 Eyes • The number of patients analyzed is different from the unit number of eyes. Each patient could have either 1 or 2 eyes enrolled into the study.
|
27 Eyes
n=60 Eyes • The number of patients analyzed is different from the unit number of eyes. Each patient could have either 1 or 2 eyes enrolled into the study.
|
238 Eyes
n=60 Eyes • The number of patients analyzed is different from the unit number of eyes. Each patient could have either 1 or 2 eyes enrolled into the study.
|
|
Cataract Grade
4-5 : :
|
15 Eyes
n=28 Eyes • The number of patients analyzed is different from the unit number of eyes. Each patient could have either 1 or 2 eyes enrolled into the study.
|
0 Eyes
n=60 Eyes • The number of patients analyzed is different from the unit number of eyes. Each patient could have either 1 or 2 eyes enrolled into the study.
|
15 Eyes
n=60 Eyes • The number of patients analyzed is different from the unit number of eyes. Each patient could have either 1 or 2 eyes enrolled into the study.
|
|
Manifest Refraction Spherical Equivalent
|
-0.91 Diopters
n=28 Eyes
|
-0.58 Diopters
n=60 Eyes
|
-0.75 Diopters
n=60 Eyes
|
|
Uncorrected Visual Acuity (UCVA) LogMAR
|
0.72 logMAR
n=28 Eyes
|
0.65 logMAR
n=60 Eyes
|
0.69 logMAR
n=60 Eyes
|
|
Best-Corrected Visual Acuity (BCVA) LogMAR
|
0.19 logMAR
n=28 Eyes
|
0.19 logMAR
n=60 Eyes
|
0.19 logMAR
n=60 Eyes
|
|
Pinhole Visual Acuity LogMAR
|
0.25 logMAR
n=28 Eyes
|
0.22 logMAR
n=60 Eyes
|
0.24 logMAR
n=60 Eyes
|
PRIMARY outcome
Timeframe: 1 day postoperativePopulation: A total of 402 subjects were enrolled into the study, 288 Phaco subjects and 114 Micor subjects. Either one or both eyes of each subject could have been enrolled into the study. Group 1 (Phaco) enrolled 449 eyes and Group 2 (Micor) enrolled 162 eyes.
1-Day postoperative UCVA measurement using LogMAR visual acuity charts
Outcome measures
| Measure |
Group 1 Phaco Subject Cohort
n=449 Eyes
The Group 1 Phaco subject cohort will begin enrolling subjects sequentially in the first initial arm of the study with up to 510 eyes total.
|
Group 2 Micor Group
n=162 Eyes
The Micor group will enroll subjects subsequent to the Phaco subject group.
|
|---|---|---|
|
UCVA Measurement
|
0.22 logMAR
Interval -0.12 to 2.3
|
0.42 logMAR
Interval -0.12 to 2.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: All adverse events will be followed from enrollment until end of the 1-day follow-up.All adverse events will be recorded and followed for safety purposes.
Outcome measures
| Measure |
Group 1 Phaco Subject Cohort
n=449 Eyes
The Group 1 Phaco subject cohort will begin enrolling subjects sequentially in the first initial arm of the study with up to 510 eyes total.
|
Group 2 Micor Group
n=162 Eyes
The Micor group will enroll subjects subsequent to the Phaco subject group.
|
|---|---|---|
|
Rate of Intraoperative and Postoperative Adverse Events.
|
32 Adverse Events
|
5 Adverse Events
|
Adverse Events
Group 1 Phaco Subject Cohort
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
Group 2 miCOR System Subject Cohort
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Group 1 Phaco Subject Cohort
n=288 participants at risk
The Group 1 Phaco subject cohort enrolled subjects sequentially in the first initial arm of the study.
|
Group 2 miCOR System Subject Cohort
n=114 participants at risk
The Group 2 MICOR System subject cohort enrolled subsequently.
|
|---|---|---|
|
Eye disorders
Retained Lens Fragment
|
0.35%
1/288 • From enrollment until end of the 1-day follow-up.
All adverse events were reported in the "study" eyes only. All adverse events reported were ocular AEs.
|
0.00%
0/114 • From enrollment until end of the 1-day follow-up.
All adverse events were reported in the "study" eyes only. All adverse events reported were ocular AEs.
|
|
Eye disorders
Retained Cortex
|
0.00%
0/288 • From enrollment until end of the 1-day follow-up.
All adverse events were reported in the "study" eyes only. All adverse events reported were ocular AEs.
|
0.88%
1/114 • From enrollment until end of the 1-day follow-up.
All adverse events were reported in the "study" eyes only. All adverse events reported were ocular AEs.
|
|
Eye disorders
Detachment Descemet's Membrane
|
0.00%
0/288 • From enrollment until end of the 1-day follow-up.
All adverse events were reported in the "study" eyes only. All adverse events reported were ocular AEs.
|
0.88%
1/114 • From enrollment until end of the 1-day follow-up.
All adverse events were reported in the "study" eyes only. All adverse events reported were ocular AEs.
|
|
Eye disorders
Raised Intraocular Pressure
|
7.6%
22/288 • From enrollment until end of the 1-day follow-up.
All adverse events were reported in the "study" eyes only. All adverse events reported were ocular AEs.
|
4.4%
5/114 • From enrollment until end of the 1-day follow-up.
All adverse events were reported in the "study" eyes only. All adverse events reported were ocular AEs.
|
|
Eye disorders
Postoperative Corneal Edema
|
1.7%
5/288 • From enrollment until end of the 1-day follow-up.
All adverse events were reported in the "study" eyes only. All adverse events reported were ocular AEs.
|
0.00%
0/114 • From enrollment until end of the 1-day follow-up.
All adverse events were reported in the "study" eyes only. All adverse events reported were ocular AEs.
|
|
Eye disorders
Anterior Chamber Cell and Flare
|
1.7%
5/288 • From enrollment until end of the 1-day follow-up.
All adverse events were reported in the "study" eyes only. All adverse events reported were ocular AEs.
|
0.00%
0/114 • From enrollment until end of the 1-day follow-up.
All adverse events were reported in the "study" eyes only. All adverse events reported were ocular AEs.
|
|
Eye disorders
Capsular Tear
|
0.35%
1/288 • From enrollment until end of the 1-day follow-up.
All adverse events were reported in the "study" eyes only. All adverse events reported were ocular AEs.
|
0.00%
0/114 • From enrollment until end of the 1-day follow-up.
All adverse events were reported in the "study" eyes only. All adverse events reported were ocular AEs.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60