Clinical Safety and Efficacy of CT ASPHINA 509 Lenses
Not Applicable
Terminated
- Conditions
- Cataract
- Registration Number
- NCT03145116
- Lead Sponsor
- Carl Zeiss Meditec AG
- Brief Summary
Clinical safety and efficacy of CT ASPHINA 509 IOLs after implantation
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 95
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Visual acuity 12 to 18 months after surgery Monocular best corrected distance visual acuity
- Secondary Outcome Measures
Name Time Method
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms underlie the hydrophilic acrylic material's efficacy in CT ASPHINA 509 IOLs for cataract correction?
How does the CT ASPHINA 509 lens compare to standard intraocular lenses in terms of postoperative visual acuity and refractive outcomes?
Are there specific ocular biomarkers that correlate with improved safety profiles in patients receiving CT ASPHINA 509 lenses?
What are the most common adverse events reported in NCT03145116 and how do they compare to other Carl Zeiss Meditec IOL trials?
How do the optical properties of CT ASPHINA 509 lenses influence photic phenomena compared to competitor aspheric IOLs like Alcon's AcrySof IQ?
Trial Locations
- Locations (1)
Augenklinink
🇩🇪Ahaus, Germany
Augenklinink🇩🇪Ahaus, Germany