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621 Real World Study

An Open Single-arm Clinical Investigation to Evaluate the Clinical Safety and Effectiveness of 621

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05646004
Enrollment
105
Registered
2022-12-12
Start date
2023-01-09
Completion date
2023-11-27
Last updated
2026-06-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Senile Cataract

Brief summary

This study is evaluating the clinical safety and effectiveness of 621, after cataract surgery.

Interventions

DEVICECataract surgery

Implantation of 621 lens

Sponsors

Carl Zeiss Meditec AG
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Inclusion: 1. Age ≥ 18 years old; 2. Patient with clinically significant cataract with planned phacoemulsification cataract extraction and implantation of IOL into the capsular bag; 3. Preoperative corneal astigmatism ≤ 1.00D; 4. Patient is willing and capable of providing informed consent; 5. Patient is willing and capable of complying with visits and procedures as defined by this protocol. Exclusion: 1. Preoperative best corrected visual acuity \> 4.7 or ≤ 0.3 logMAR; 2. Corneal endothelial cell count less than 2000 cell/mm2; 3. Age under 18 years old; 4. Pregnant and lactating women; 5. Patients who attend other drug or medical device study; 6. Ocular disorder that could potentially cause a clinically significant future visual acuity loss; 7. Anterior segment pathology (e.g. chronic uveitis, iritis, aniridia, rubeosis iridis, anterior membrane dystrophies, poor pupil dilation, etc.) 8. Abnormal corneal finding (e.g. keratoconus, pellucid marginal degeneration, or irregular astigmatism, clinically significant corneal membrane dystrophies); 9. Any condition in the study eye that could affect IOL stability (e.g. pseudo-exfoliation, zonular dialysis, evident zonular weakness or dehiscence, etc; 10. Any acute infection (acute ocular disease, external/internal infection, systemic infection); 11. History of any clinically significant retinal pathology or ocular diagnosis (e.g. diabetic retinopathy, ischemic diseases, macular degeneration, retinal detachment, optic neuropathy, amblyopia, strabismus, microphthalmia, aniridia, epiretinal membrane etc.) in the study eye that could alter or limit final postoperative visual prognosis; 12. Any previous intraocular and corneal surgery ; 13. Uncontrolled glaucoma or IOP higher than 24mmHg under ocular hypertension treatment; 14. Current systemic or ocular pharmacotherapy that effects patients' vision; 15. Current pathology or condition that could be a risk for the patient according to the investigator opinion; 16. Patients unable to meet the limitations of the protocol or likely of non-cooperation during the clinical investigation; 17. Patients whose freedom is impaired by administrative or legal order.

Design outcomes

Primary

MeasureTime frameDescription
Percentage of Participants With a Monocular CDVA ≤0.3 logMAR at 6 Months Postoperatively6 monthsPercentage of Participants with a Monocular CDVA ≤0.3 logMAR at 6 Months Postoperatively,

Countries

China

Baseline characteristics

Characteristic
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
90 Participants
Age, Categorical
Between 18 and 65 years
15 Participants
Age, Continuous70.1 years
STANDARD_DEVIATION 6.1
best corrected visual acuity0.59 LogMar
STANDARD_DEVIATION 0.27
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
105 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
Region of Enrollment
China
105 participants
Sex: Female, Male
Female
57 Participants
Sex: Female, Male
Male
48 Participants
uncorrected visual acuity0.76 LogMar
STANDARD_DEVIATION 0.25

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 105
other
Total, other adverse events
9 / 105
serious
Total, serious adverse events
0 / 105

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 26, 2026