AMO's Tecnis™ Multifocal Intraocular Lenses (Tecnis MF), Alcon's ReStor Multifocal IOL
Launched by INNOVATIVE MEDICAL · Jan 14, 2011
Trial Information
Current as of April 24, 2025
Unknown status
Keywords
ClinConnect 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.
Gender
ALL
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
Trial Officials
William Trattler, MD
Principal Investigator
The Center for Excellence in Eye Care
Mitch Jackson, MD
Principal Investigator
Jackson Eye
Larry Katzen, MD
Principal Investigator
Katzen Eye Care & Laser Center
Kevin Waltz, MD
Principal Investigator
Eye Surgeons of Indiana
Shamik Bafna, MD
Principal Investigator
Clevland Eye Clinic
About Innovative Medical
Innovative Medical is a forward-thinking clinical trial sponsor dedicated to advancing healthcare through the development of groundbreaking therapies and medical technologies. With a focus on patient-centric research, Innovative Medical collaborates with leading healthcare professionals and institutions to conduct rigorous clinical trials that adhere to the highest standards of safety and efficacy. The organization is committed to fostering innovation and improving patient outcomes by bridging the gap between scientific discovery and real-world application, ultimately contributing to the evolution of modern medicine.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Miami, Florida, United States
Indianapolis, Indiana, United States
Santa Barbara, California, United States
Boynton Beach, Florida, United States
Lake Villa,, Illinois, United States
Breckville, Ohio, United States
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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