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Search / Trial NCT01278420

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

Visual Outcomes With Bilateral Implantation Of Tecnis Mf And Re Stor Io Ls Six Months Post Cataract Surgery

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.

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

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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