Senile CataractNCT05646004
621 Real World Study
A study testing Cataract surgery in people with Senile Cataract, run by Carl Zeiss Meditec AG at 1 site in China.
Trial summary
This study is evaluating the clinical safety and effectiveness of 621, after cataract surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Senile Cataract
- What is being tested?
- Cataract surgery
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteChina
- Study dates
- 9 Jan 2023to 27 Nov 2023
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years old;
- Patient with clinically significant cataract with planned phacoemulsification cataract extraction and implantation of IOL into the capsular bag;
- Preoperative corneal astigmatism ≤ 1.00D;
- Patient is willing and capable of providing informed consent;
- Patient is willing and capable of complying with visits and procedures as defined by this protocol.
Who cannot join
- Preoperative best corrected visual acuity > 4.7 or ≤ 0.3 logMAR;
- Corneal endothelial cell count less than 2000 cell/mm2;
- Age under 18 years old;
- Pregnant and lactating women;
- Patients who attend other drug or medical device study;
- Ocular disorder that could potentially cause a clinically significant future visual acuity loss;
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- Anterior segment pathology (e.g. chronic uveitis, iritis, aniridia, rubeosis iridis, anterior membrane dystrophies, poor pupil dilation, etc.)
- Abnormal corneal finding (e.g. keratoconus, pellucid marginal degeneration, or irregular astigmatism, clinically significant corneal membrane dystrophies);
- Any condition in the study eye that could affect IOL stability (e.g. pseudo-exfoliation, zonular dialysis, evident zonular weakness or dehiscence, etc;
- Any acute infection (acute ocular disease, external/internal infection, systemic infection);
- 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;
- Any previous intraocular and corneal surgery ;
- Uncontrolled glaucoma or IOP higher than 24mmHg under ocular hypertension treatment;
- Current systemic or ocular pharmacotherapy that effects patients' vision;
- Current pathology or condition that could be a risk for the patient according to the investigator opinion;
- Patients unable to meet the limitations of the protocol or likely of non-cooperation during the clinical investigation;
- Patients whose freedom is impaired by administrative or legal order.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open Single-arm Clinical Investigation to Evaluate the Clinical Safety and Effectiveness of 621
This study is evaluating the clinical safety and effectiveness of 621, after cataract surgery.
- Conditions
- Senile Cataract
- Being tested
- Cataract surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cataract surgeryDevice
Implantation of 621 lens
| Study group | Role | What they receive |
|---|---|---|
| 621 | Experimental | Not described Receives: Device: Cataract surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With a Monocular CDVA ≤0.3 logMAR at 6 Months Postoperatively
Percentage of Participants with a Monocular CDVA ≤0.3 logMAR at 6 Months Postoperatively,
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2022
- Study start9 Jan 2023
- Primary completion27 Nov 2023
- Study completion27 Nov 2023
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 Senile CataractStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carl Zeiss Meditec AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05646004
- Sponsor's protocol ID
- 621P-BER-401-21
- Status last verified
- Apr 2026
- First submitted
- 2 Dec 2022
- Last updated
- 25 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Single-arm Clinical Investigation to Evaluate the Clinical Safety and Effectiveness of 621
- ClinicalTrials.gov ID
- NCT05646004
- Acronym / sponsor ID
- 621P-BER-401-21
- Conditions
- Senile Cataract
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Carl Zeiss Meditec AGIndustry (pharma, biotech, devices)
- Study start
- 9 Jan 2023 (actual)
- Primary completion
- 27 Nov 2023 (actual)
- Study completion
- 27 Nov 2023 (actual)
- First posted
- 12 Dec 2022 (actual)
- Results
- Posted 25 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is evaluating the clinical safety and effectiveness of 621, after cataract surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 621 | Experimental | Device: Cataract surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 18 years old;
- Patient with clinically significant cataract with planned phacoemulsification cataract extraction and implantation of IOL into the capsular bag;
- Preoperative corneal astigmatism ≤ 1.00D;
- Patient is willing and capable of providing informed consent;
- Patient is willing and capable of complying with visits and procedures as defined by this protocol.
Key exclusion criteria (17 listed)
- Preoperative best corrected visual acuity > 4.7 or ≤ 0.3 logMAR;
- Corneal endothelial cell count less than 2000 cell/mm2;
- Age under 18 years old;
- Pregnant and lactating women;
- Patients who attend other drug or medical device 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 |
|---|---|---|
| Cataract surgeryImplantation of 621 lens | Device | 621 |
Primary outcome
Percentage of Participants With a Monocular CDVA ≤0.3 logMAR at 6 Months Postoperatively
Time frame: 6 months
Percentage of Participants with a Monocular CDVA ≤0.3 logMAR at 6 Months Postoperatively,
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cataract surgery in people with Senile Cataract, run by Carl Zeiss Meditec AG at 1 site in China.
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 5 inclusion and 17 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: finished, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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 25 Jun 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?
Percentage of Participants With a Monocular CDVA ≤0.3 logMAR at 6 Months Postoperatively (time frame: 6 months). 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 25 Jun 2026.