Clinical Safety and Efficacy of CT ASPHINA 509 Lenses

Not Applicable

Terminated

• Conditions: Cataract
• Interventions: Device: CT ASPHINA 509

• 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

Study Timeline

• Study First Submitted: 2017-05-05
• Study First Submitted QC: 2017-05-05
• Study First Posted: 2017-05-09
• Study Start: 2017-09-22
• Status Verified: 2018-01
• Primary Completion: 2018-02-05
• Study Completion: 2018-02-05
• Last Update Submitted: 2018-07-17
• Last Update Posted: 2018-07-18

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

Arm && Interventions

Group	Intervention	Description
509	CT ASPHINA 509	-

Primary Outcome Measures

Name	Time	Method
Visual acuity	12 to 18 months after surgery	Monocular best corrected distance visual acuity

Trial Locations

Locations (1)

Augenklinink; 🇩🇪 Ahaus, Germany