Back to resultsClinical Safety and Efficacy of CT ASPHINA 509 Lenses (UVEA509)
Primary Purpose
Cataract
Status
Terminated
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
CT ASPHINA 509
Sponsored by
About this trial
This is an interventional treatment trial for Cataract
Eligibility Criteria
Inclusion Criteria:
Patient informed of the consequences and constraints of the protocol and who has given his/her written informed consent;
- Patients of any gender
- Assured follow-up examinations
- Biometry measurement preferably compatible with the IOLMaster evaluation;
- IOL implanted into the capsular bag with IOL model CT ASPHINA 409MP (UVE material) in one eye with at least 12 months follow up at the time of the postop visit
- Patients who had uncomplicated (no peroperative complication) agedrelated cataract surgery in a healthy eye (beside clinically significant cataract)
Exclusion Criteria:
• BCVA not available preoperatively or better than 0.3 logMAR pre-op
- Patients unable to meet the limitations of the protocol or likely of noncooperation during the trial
- Patients whose freedom is impaired by administrative or legal order
- Concurrent participation in another drug or device investigation
Sites / Locations
- Augenklinink
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
509
Arm Description
Outcomes
Primary Outcome Measures
Visual acuity
Monocular best corrected distance visual acuity
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03145116
Brief Title
Clinical Safety and Efficacy of CT ASPHINA 509 Lenses
Acronym
UVEA509
Official Title
Clinical Safety and Efficacy of Hydrophilic Acrylic Intraocular Lenses - Retro Prospective Study
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Terminated
Why Stopped
recruitment rate
Study Start Date
September 22, 2017 (Actual)
Primary Completion Date
February 5, 2018 (Actual)
Study Completion Date
February 5, 2018 (Actual)
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
Data Monitoring Committee
No
5. Study Description
Brief Summary
Clinical safety and efficacy of CT ASPHINA 509 IOLs after implantation
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
95 (Actual)
8. Arms, Groups, and Interventions
Arm Title
509
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
CT ASPHINA 509
Intervention Description
Intraocular lens
Primary Outcome Measure Information:
Title
Visual acuity
Description
Monocular best corrected distance visual acuity
Time Frame
12 to 18 months after surgery
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient informed of the consequences and constraints of the protocol and who has given his/her written informed consent;
Patients of any gender
Assured follow-up examinations
Biometry measurement preferably compatible with the IOLMaster evaluation;
IOL implanted into the capsular bag with IOL model CT ASPHINA 409MP (UVE material) in one eye with at least 12 months follow up at the time of the postop visit
Patients who had uncomplicated (no peroperative complication) agedrelated cataract surgery in a healthy eye (beside clinically significant cataract)
Exclusion Criteria:
• BCVA not available preoperatively or better than 0.3 logMAR pre-op
Patients unable to meet the limitations of the protocol or likely of noncooperation during the trial
Patients whose freedom is impaired by administrative or legal order
Concurrent participation in another drug or device investigation
Facility Information:
Facility Name
Augenklinink
City
Ahaus
ZIP/Postal Code
12593
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Clinical Safety and Efficacy of CT ASPHINA 509 Lenses
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