Clinical Safety and Efficacy of CT ASPHINA 509 Lenses (UVEA509)

Carl Zeiss Meditec

Status: Terminated

Conditions: Cataract

Treatments: Device: CT ASPHINA 509

Study type: Interventional

Funder types: Industry

Identifiers

NCT03145116

ASPHINA 509-BER-401-17

Details and patient eligibility

About

Clinical safety and efficacy of CT ASPHINA 509 IOLs after implantation

Enrollment: 95 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) 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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95 participants in 1 patient group

509

Experimental group

Treatment:

Device: CT ASPHINA 509