Evaluation Of Bilateral Tecnis Multifocal Versus ReSTOR 3D Intraocular Lenses

This study has been completed.
Sponsor:
Information provided by:
Innovative Medical
ClinicalTrials.gov Identifier:
NCT01061918
First received: February 2, 2010
Last updated: February 16, 2011
Last verified: February 2011
  Purpose

The purpose of this study is to compare the visual outcomes with bilateral implantation of Tecnis MF and ReSTOR intraocular lenses (IOLs) 6 months post cataract surgery.


Condition Intervention Phase
Cataract
Device: Tecnis MF
Device: ReSTOR
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Evaluation Of Bilateral Tecnis Multifocal Versus ReSTOR 3D Intraocular Lenses

Resource links provided by NLM:


Further study details as provided by Innovative Medical:

Primary Outcome Measures:
  • Refraction [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Distance Visual Acuities [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: August 2009
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Tecnis MF Device: Tecnis MF
20 patients in the Tecnis MF group.
Active Comparator: ReSTOR Device: ReSTOR
20 patients in the ReSTOR group.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18 or greater
  • Bilateral cataracts for which phacoemulsification extraction and posterior IOL implantation has been planned for both eyes
  • Visual potential of 20/30 or better in each eye after cataract removal and IOL implantation
  • Preoperative best-corrected distance visual acuity (BSDVA) worse than 20/40 Snellen. If there is a glare component, glare testing which reduces the visual acuity to less than 20/40
  • Naturally dilated pupil size (in dim light) > 3.5 mm (with no dilation medications) for both eyes
  • Preoperative corneal astigmatism of 1.0 D or less
  • Clear intraocular media other than cataract
  • Availability, willingness, and sufficient cognitive awareness to comply with examination procedures

Exclusion Criteria:

  • Use of systemic or ocular medications that may affect vision
  • Acute or chronic disease or illness that would increase risk or confound study results (e.g. diabetes mellitus, immunocompromised, etc.)
  • Subjects with diabetes mellitus
  • Uncontrolled systemic or ocular disease
  • History of ocular trauma or prior ocular surgery
  • 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 20/30 or worse
  • Subjects who may be expected to require retinal laser treatment or other surgical intervention
  • Capsule or zonular abnormalities that may affect postoperative centration or tilt of the lens (e.g. pseudoexfoliation syndrome)
  • Pupil abnormalities (non-reactive, tonic pupils, abnormally shaped pupils, or pupils that do not dilate at least 4.0 mm under mesopic/scotopic conditions)
  • Contact lens usage within 6 months for polymethyl methacrylate (PMMA) contacts lenses, 1 month for gas permeable lenses or 1 week for extended-wear and daily-wear soft contact lenses
  • Requiring an intraocular lens <15.0 or >26.0 diopters
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01061918

Locations
United States, Florida
William Trattler
Miami, Florida, United States, 33176
William Lahners
Sarasota, Florida, United States, 34239
Sponsors and Collaborators
Innovative Medical
  More Information

No publications provided

Responsible Party: William Lahners, Center For Sight
ClinicalTrials.gov Identifier: NCT01061918     History of Changes
Other Study ID Numbers: Tecnis MF/Restor
Study First Received: February 2, 2010
Last Updated: February 16, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Innovative Medical:
Compare the visual outcomes with bilateral implantation of Tecnis MF and ReSTOR IOLs 6 months post cataract surgery.

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases

ClinicalTrials.gov processed this record on August 28, 2014