621 Real World Study

Carl Zeiss Meditec

Status: Enrolling

Conditions: Senile Cataract

Treatments: Device: Cataract surgery

Study type: Interventional

Funder types: Industry

Identifiers

NCT05646004

621P-BER-401-21

Details and patient eligibility

About

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

Enrollment: 105 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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105 participants in 1 patient group

621

Experimental group

Treatment:

Device: Cataract surgery