search
Back to results

621 Real World Study

Primary Purpose

Senile Cataract

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Cataract surgery
Sponsored by
Carl Zeiss Meditec AG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Senile Cataract

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion: 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. Exclusion: 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; Patients unable to meet the limitations of the protocol or likely of non-cooperation during the clinical investigation; Patients whose freedom is impaired by administrative or legal order.

Sites / Locations

  • Hainan Boao Lecheng Aier Eye HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

621

Arm Description

Outcomes

Primary Outcome Measures

Corrected Distance Visual Acuity (CDVA)
measurement of CDVA after IOL implantation

Secondary Outcome Measures

Full Information

First Posted
December 2, 2022
Last Updated
January 9, 2023
Sponsor
Carl Zeiss Meditec AG
search

1. Study Identification

Unique Protocol Identification Number
NCT05646004
Brief Title
621 Real World Study
Official Title
An Open Single-arm Clinical Investigation to Evaluate the Clinical Safety and Effectiveness of 621
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 9, 2023 (Actual)
Primary Completion Date
September 1, 2024 (Anticipated)
Study Completion Date
September 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Carl Zeiss Meditec AG

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Senile Cataract

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
105 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
621
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Cataract surgery
Intervention Description
Implantation of 621 lens
Primary Outcome Measure Information:
Title
Corrected Distance Visual Acuity (CDVA)
Description
measurement of CDVA after IOL implantation
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion: 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. Exclusion: 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; Patients unable to meet the limitations of the protocol or likely of non-cooperation during the clinical investigation; Patients whose freedom is impaired by administrative or legal order.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
CZM Clinical Affairs
Phone
+49 30 8540010
Email
clinicalstudies.meditec.sur@zeiss.com
First Name & Middle Initial & Last Name or Official Title & Degree
Santiago Furio Lanuza
Phone
+49 30 85 4001 296
Email
santiago.furio-lanuza@zeiss.com
Facility Information:
Facility Name
Hainan Boao Lecheng Aier Eye Hospital
City
Qionghai
State/Province
Hainan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aier Eye
Phone
13118913565

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

621 Real World Study

We'll reach out to this number within 24 hrs