NCT01731743CompletedNot Applicable
Evaluation of Visual Acuity and Patient Satisfaction With AT LISA TRI 839MP Intraocular Lenses
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Carl Zeiss Meditec AG
- Enrollment
- 107
- Locations
- 1
- Primary Endpoint
- Intermediate visual acuity
Study Overview
Brief Summary
The purpose of the study is to evaluate the far, intermediate and near visual acuities with a trifocal IOL.
Detailed Description
After bilateral cataract surgery, monocular and binocular uncorrected (UCVA) and best distance corrected visual acuity (BCVA) will be measured at far (4m), intermediate (80 cm) and near (40 cm) distance as well as the subjective refraction.
A patient questionnaire will be used to assess the patient satisfaction and spectacle independence.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 50 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Man or woman, over 50 years of age
- •Bilateral implantation of a trifocal intraocular lens
- •Capsular bag implantation
Exclusion Criteria
- •Existing ocular pathology
- •Surgical complications
- •Corneal astigmatism ≥ 1.0D
Arms & Interventions
implantation of a trifocal IOL (AT LISA tri 839MP)
Other
Intervention: AT LISA tri 839MP (Device)
Outcomes
Primary Outcomes
Intermediate visual acuity
Time Frame: up to 3 months postoperatively
Monocular and binocular uncorrected and best distance corrected
Secondary Outcomes
- near and far visual acuity(1 and 3 month postoperatively)
Investigators
Study Sites (1)
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