NCT01278420UnknownPhase 4
AMO's Tecnis™ Multifocal Intraocular Lenses (Tecnis MF), Alcon's ReStor Multifocal IOL
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 4
- Sponsor
- Innovative Medical
- Enrollment
- 60
- Locations
- 6
- Primary Endpoint
- Intermediate Acuities
Study Overview
Brief Summary
The purpose of this study is to compare the visual outcomes with bilateral implantation of Tecnis MF and ReSTOR IOLs Six months post cataract surgery.
Detailed Description
The purpose of this study is to compare the visual outcomes with bilateral implantation of Tecnis MF and ReSTOR IOLs Six months post cataract surgery.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Age 18 or greater
- •Bilateral condition (cataracts or Presbyopia) for which phacoemulsification and posterior IOL implantation has been planned for both eyes
- •Visual potential of 20/25 or better in each eye after cataract removal and IOL implantation
- •Clear intraocular media other than cataract
- •Normal OCT of the macula
- •No evidence of Keratoconus or significant irregular astigmatism on Preoperative topography
- •No evidence of Epithelial Basement Membrane Dystrophy on Slit lamp Exam
- •Availability, willingness, and sufficient cognitive awareness to comply with examination procedures
Exclusion Criteria
- •Use of systemic or ocular medications that may affect vision
- •Uncontrolled systemic or ocular disease
- •History of ocular trauma
- •History of intraocular, extraocular Muscle, or corneal surgery (including laser vision correction)
- •Amblyopia or strabismus
- •Known pathology that may affect visual acuity; particularly retinal changes that affect vision (macular degeneration, cystoid macular edema, proliferative diabetic retinopathy, etc.)
- •Diagnosed degenerative visual disorders (e.g. macular degeneration, or other retinal disorders) that are predicted to cause future acuity losses to a level of 20/25 or worse
- •Subjects who may be expected to require retinal laser treatment or other surgical intervention (i.e patients with diabetic retinopathy)
- •Capsule or zonular abnormalities that may affect postoperative centration or tilt of the lens (e.g. pseudoexfoliation syndrome)
- •Contact lens usage within 2 months for PMMA contacts lenses, 2 weeks for gas permeable lenses or 3 days for extended-wear and daily-wear soft contact lenses
Arms & Interventions
Tecnis MF
Other
Intervention: Tecnis MF (Device)
ReSTOR
Other
Intervention: ReSTOR (Device)
Outcomes
Primary Outcomes
Intermediate Acuities
Time Frame: 1 year
Refraction
Time Frame: 1 year
Distance Visual Acuities
Time Frame: 1 year
Near Visual Acuities
Time Frame: 1 year
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (6)
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