621 Real World Study

Senile Cataract Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05646004
• Other study ID #: 621P-BER-401-21
• Status: Recruiting
• Phase: N/A
• Start date: January 9, 2023
• Est. completion date: September 1, 2024

Study information

• Verified date: January 2023
• Source: Carl Zeiss Meditec AG
• Contact: CZM Clinical Affairs
• Phone: +49 30 8540010
• Email: clinicalstudies.meditec.sur[@]zeiss.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 105
• Est. completion date: September 1, 2024
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cataract
• Senile Cataract

Intervention

Device:
• Cataract surgery
Implantation of 621 lens

Locations

Country	Name	City	State
China	Hainan Boao Lecheng Aier Eye Hospital	Qionghai	Hainan

Sponsors (1)

Lead Sponsor	Collaborator
Carl Zeiss Meditec AG

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Corrected Distance Visual Acuity (CDVA)	measurement of CDVA after IOL implantation	6 months