Clinical Safety and Efficacy of Hydrophilic Acrylic Intraocular Lenses
Not Applicable
Completed
- Conditions
- Cataract
- Interventions
- Device: CT ASPHINA 409
- Registration Number
- NCT03145103
- Lead Sponsor
- Carl Zeiss Meditec AG
- Brief Summary
Clinical safety and efficacy of CT ASPHINA 409 IOLs after implantation
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 282
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) aged-related 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 non-cooperation 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
- Arm && Interventions
Group Intervention Description 409M CT ASPHINA 409 CT ASPHINA 409M IOL
- 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
Trial Locations
- Locations (1)
Department of Ophthalmology
🇸🇪Linköping, Sweden