AMO's Tecnis™ Multifocal Intraocular Lenses (Tecnis MF), Alcon's ReStor Multifocal IOL

Innovative Medical

Status and phase

Unknown

Phase 4

Conditions

Cataract

Treatments

Device: Tecnis MF

Device: ReSTOR

Study type

Interventional

Funder types

Industry

Identifiers

NCT01278420

TMF vs Restor MF 3D

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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