621 Real World Study

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.

Study Overview

• Status: Completed
• Conditions: Senile Cataract
• Intervention / Treatment: Device: Cataract surgery

• Study Type: Interventional
• Enrollment (Actual): 105
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Hainan
    • Qionghai, Hainan, China
      • Hainan Boao Lecheng Aier Eye Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 621	Device: Cataract surgery; Implantation of 621 lens

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Corrected Distance Visual Acuity (CDVA)	measurement of CDVA after IOL implantation	6 months

Collaborators and Investigators

• Sponsor: Carl Zeiss Meditec AG

Study record dates

Study Major Dates

• Study Start (Actual): January 9, 2023
• Primary Completion (Actual): November 27, 2023
• Study Completion (Actual): November 27, 2023

Study Registration Dates

• First Submitted: December 2, 2022
• First Submitted That Met QC Criteria: December 2, 2022
• First Posted (Actual): December 12, 2022

Study Record Updates

• Last Update Posted (Actual): April 20, 2026
• Last Update Submitted That Met QC Criteria: April 15, 2026
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract; Surgical Procedures, Operative; Ophthalmologic Surgical Procedures; Refractive Surgical Procedures; Cataract Extraction
• Other Study ID Numbers: 621P-BER-401-21

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No