Clinical Safety and Efficacy of CT ASPHINA 509 Lenses

Cataract Clinical Trial

— UVEA509  

Official title:

Clinical Safety and Efficacy of Hydrophilic Acrylic Intraocular Lenses - Retro Prospective Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03145116
• Other study ID #: ASPHINA 509-BER-401-17
• Status: Terminated
• Phase: N/A
• Start date: September 22, 2017
• Est. completion date: February 5, 2018

Study information

• Verified date: January 2018
• Source: Carl Zeiss Meditec AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Clinical safety and efficacy of CT ASPHINA 509 IOLs after implantation

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 95
• Est. completion date: February 5, 2018
• Est. primary completion date: February 5, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Cataract

Intervention

Device:
• CT ASPHINA 509
Intraocular lens

Locations

Country	Name	City	State
Germany	Augenklinink	Ahaus

Sponsors (1)

Lead Sponsor	Collaborator
Carl Zeiss Meditec AG

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual acuity	Monocular best corrected distance visual acuity	12 to 18 months after surgery