Trial Outcomes & Findings for 621 Real World Study (NCT NCT05646004)
NCT ID: NCT05646004
Last Updated: 2026-06-25
Results Overview
Percentage of Participants with a Monocular CDVA ≤0.3 logMAR at 6 Months Postoperatively,
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
105 participants
Primary outcome timeframe
6 months
Results posted on
2026-06-25
Participant Flow
Participant milestones
| Measure |
CT LUCIA 621P
Cataract surgery: Implantation of 621 lens
|
|---|---|
|
Overall Study
STARTED
|
105
|
|
Overall Study
COMPLETED
|
105
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
621 Real World Study
Baseline characteristics by cohort
| Measure |
CT LUCIA 621P
n=105 Participants
Cataract surgery: Implantation of 621 lens
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=20 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=20 Participants
|
|
Age, Categorical
>=65 years
|
90 Participants
n=20 Participants
|
|
Age, Continuous
|
70.1 years
STANDARD_DEVIATION 6.1 • n=20 Participants
|
|
Sex: Female, Male
Female
|
57 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
48 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
105 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
|
Region of Enrollment
China
|
105 participants
n=20 Participants
|
|
best corrected visual acuity
|
0.59 LogMar
STANDARD_DEVIATION 0.27 • n=20 Participants
|
|
uncorrected visual acuity
|
0.76 LogMar
STANDARD_DEVIATION 0.25 • n=20 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPercentage of Participants with a Monocular CDVA ≤0.3 logMAR at 6 Months Postoperatively,
Outcome measures
| Measure |
CT LUCIA 621P
n=105 Participants
Cataract surgery: Implantation of 621 lens
|
|---|---|
|
Percentage of Participants With a Monocular CDVA ≤0.3 logMAR at 6 Months Postoperatively
|
99 Percentage of participants
Interval 94.81 to 99.98
|
Adverse Events
CT LUCIA 621P
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
CT LUCIA 621P
n=105 participants at risk
Cataract surgery: Implantation of 621 lens
|
|---|---|
|
Eye disorders
Expected Adverse Events
|
0.95%
1/105 • Number of events 1 • 6 months
|
|
Eye disorders
Adverse Events Related to Study Device
|
0.95%
1/105 • Number of events 1 • 6 months
|
|
Eye disorders
Adverse Events Related to Surgery
|
3.8%
4/105 • Number of events 4 • 6 months
|
|
Eye disorders
Adverse Events Requiring Corrective Treatment
|
2.9%
3/105 • Number of events 3 • 6 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60