Cataract
Conditions
Brief summary
Clinical safety and efficacy of CT ASPHINA 409 IOLs after implantation
Interventions
DEVICECT ASPHINA 409
intraocular lens
Sponsors
Carl Zeiss Meditec AG
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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 -
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual acuity | 12 to 18 months after surgery | Monocular best corrected distance visual acuity |
Countries
Sweden
Outcome results
None listed