A Clinical Assessment of Visual Performance of Combining the Tecnis Symfony Extended Range of Vision IOL (ZXR00) With the +3.25D Tecnis Multifocal 1-Piece IOL (ZLB00) in Subjects Undergoing Bilateral Cataract Extraction
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 50
- Locations
- 2
- Primary Endpoint
- Visual Acuity
Study Overview
Brief Summary
This will be a single center, non comparison clinical trial. Fifty study patients will have the Symfony IOL implanted in their dominant eye and a +3,25D Tecnis Multifocal in their non-dominant eye. The investigators will be evaluated vision at distance, intermediate and near as well as assessing patient satisfaction and spectacle independence.
Detailed Description
Each study patient will undergo the same routine cataract extraction procedure in each eye. In their dominant eye a Tecnis Symfony IOL will be implanted and in the non dominant eye, a Tecnis +3.25D Multifocal implanted. The surgeries will be within 2 days of each other. Every patient will receive same postoperative instructions and medications. The aim is to investigate the potential benefits of implanting two different IOL's to give the patient a wider range of near vision with decreased risk of haloing and glare to enable them to be less dependent on reading glasses
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 21 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •good general health,
- •willing to comply with study instructions,
- •Visual potential of 20/30 or better,
- •less than 1.5D of corneal astigmatism,
- •normal macula,
- •clear lens or cataract,
- •pupil size greater than 3.5mm
Exclusion Criteria
- •known pathology to affect visual outcome,
- •amblyopia or strabismus,
- •pupil abnormalities,
- •zonule problems,
- •keratoconus,
- •no prior ocular surgery,use of medication that could affect vision,
- •uncontrolled systemic disease
Arms & Interventions
Surgery Patient
All patients to be implanted bilaterally with a Tecnis Extended Range Lens in the Dominant eye and a Low Add Multifocal in the non dominant
Intervention: Cataract Surgery (Procedure)
Outcomes
Primary Outcomes
Visual Acuity
Time Frame: 3 months
Vision will be measured at distance, intermediate and near with and without correction.
Secondary Outcomes
- Patient Satisfaction(3 months)