NCT03145103CompletedNot Applicable
Clinical Safety and Efficacy of Hydrophilic Acrylic Intraocular Lenses - Retro Prospective Study
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Carl Zeiss Meditec AG
- Enrollment
- 282
- Locations
- 2
- Primary Endpoint
- Visual acuity
Study Overview
Brief Summary
Clinical safety and efficacy of CT ASPHINA 409 IOLs after implantation
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Sex
- All
- Accepts 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 -
Arms & Interventions
409M
Experimental
CT ASPHINA 409M IOL
Intervention: CT ASPHINA 409 (Device)
Outcomes
Primary Outcomes
Visual acuity
Time Frame: 12 to 18 months after surgery
Monocular best corrected distance visual acuity
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (2)
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