Clinical trial NCT01278420: AMO's Tecnis™ Multifocal Intraocular Lenses (Tecnis MF), Alcon's ReStor Multifocal IOL
Official title: AMO's Tecnis™ Multifocal Intraocular Lenses (Tecnis MF), Alcon's ReStor Multifocal IOL
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Cataract
Keywords: Visual outcomes with bilateral implantation of Tecnis MF and ReSTOR IOLs Six months post cataract surgery
Lead sponsor: Innovative Medical
Sponsor class: INDUSTRY
First posted: 2011-01-17
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Refraction
timeFrame: 1 year
measure: Distance Visual Acuities
timeFrame: 1 year
measure: Near Visual Acuities
timeFrame: 1 year
measure: Intermediate Acuities
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Santa Barbara
country: United States
facility: Sansum- Santa Barbara medical foundation Clinic
state: California
city: Boynton Beach
country: United States
facility: Katzen Eye Care & Laser Center
state: Florida
city: Miami
country: United States
facility: The Center for Excellence in Eye Care
state: Florida
city: Lake Villa,
country: United States
facility: Jackson Eye, SC
state: Illinois
city: Indianapolis
country: United States
facility: Eye Surgeons of Indiana
state: Indiana
city: Breckville
country: United States
facility: Cleveland Eye Clinic
state: Ohio
Study officials:
affiliation: The Center for Excellence in Eye Care
name: William Trattler, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Jackson Eye
name: Mitch Jackson, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Katzen Eye Care & Laser Center
name: Larry Katzen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Eye Surgeons of Indiana
name: Kevin Waltz, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Clevland Eye Clinic
name: Shamik Bafna, MD
role: PRINCIPAL_INVESTIGATOR
References: