Clinical Safety and Efficacy of Hydrophilic Acrylic Intraocular Lenses (UVEA409)

Carl Zeiss Meditec

Status

Completed

Conditions

Cataract

Treatments

Device: CT ASPHINA 409

Study type

Interventional

Funder types

Industry

Identifiers

ASPHINA 409-BER-401-17

Details and patient eligibility

About

Clinical safety and efficacy of CT ASPHINA 409 IOLs after implantation

Enrollment

282 patients

Sex

All

Volunteers

No Healthy Volunteers

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 -