AMO's Tecnis™ Multifocal Intraocular Lenses (Tecnis MF), Alcon's ReStor Multifocal IOL
Status unconfirmed · Phase 4
Conditions studied: Cataract
In brief
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.
Key facts
- Study ID
- NCT01278420
- Run by
- Innovative Medical
- People needed
- 60
- Starts
- 2010-09-01
- Expected to finish
- 2012-12-01
- Last updated by the study team
- 2012-06-14
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Katzen Eye Care & Laser Center — Boynton Beach, Florida, United States (enrolling)
- The Center for Excellence in Eye Care — Miami, Florida, United States (enrolling)
- Jackson Eye, SC — Lake Villa, Illinois, United States (enrolling)
- Eye Surgeons of Indiana — Indianapolis, Indiana, United States (enrolling)
- Cleveland Eye Clinic — Breckville, Ohio, United States (enrolling)
- Sansum- Santa Barbara medical foundation Clinic — Santa Barbara, California, United States
Full record on ClinicalTrials.gov
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