621 Real World Study

Sponsor
Carl Zeiss Meditec AG (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05646004
Collaborator
(none)
105
1
1
19.7
5.3

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Device: Cataract surgery
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
105 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Open Single-arm Clinical Investigation to Evaluate the Clinical Safety and Effectiveness of 621
Actual Study Start Date :
Jan 9, 2023
Anticipated Primary Completion Date :
Sep 1, 2024
Anticipated Study Completion Date :
Sep 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: 621

Device: Cataract surgery
Implantation of 621 lens

Outcome Measures

Primary Outcome Measures

  1. Corrected Distance Visual Acuity (CDVA) [6 months]

    measurement of CDVA after IOL implantation

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hainan Boao Lecheng Aier Eye Hospital Qionghai Hainan China

Sponsors and Collaborators

  • Carl Zeiss Meditec AG

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Carl Zeiss Meditec AG
ClinicalTrials.gov Identifier:
NCT05646004
Other Study ID Numbers:
  • 621P-BER-401-21
First Posted:
Dec 12, 2022
Last Update Posted:
Jan 10, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 10, 2023