621 Real World Study

NCT05646004 | Completed

• 1 other identifier: 621P-BER-401-21
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Senile Cataract

Outcome Measures

Primary Outcomes (1)

• Corrected Distance Visual Acuity (CDVA)

  measurement of CDVA after IOL implantation

  6 months

Study Arms (1)

621

EXPERIMENTAL

Device: Cataract surgery

Interventions

Cataract surgery DEVICE

Implantation of 621 lens

621

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• Carl Zeiss Meditec AG: lead

Study Sites (1)

Hainan Boao Lecheng Aier Eye Hospital

Qionghai, Hainan, China

Location

MeSH Terms

Interventions

Cataract Extraction

Intervention Hierarchy (Ancestors)

Refractive Surgical Procedures; Ophthalmologic Surgical Procedures; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2022
• First Posted: December 12, 2022
• Study Start: January 9, 2023
• Primary Completion: November 27, 2023
• Study Completion: November 27, 2023
• Last Updated: April 20, 2026

Record last verified: 2023-01

Locations

CN (1)