Evaluation of the Tecnis™ Multifocal and Crystalens™ Accommodating Intraocular Lenses

This study has been completed.
Sponsor:
Information provided by:
Innovative Medical
ClinicalTrials.gov Identifier:
NCT01061281
First received: February 1, 2010
Last updated: January 13, 2012
Last verified: January 2012
  Purpose

The purpose of this study is to compare the visual outcomes with bilateral implantation of Tecnis MF and Crystalens™ AO Aberration-free Accommodating intraocular lens (IOLs) 6 months after post cataract surgery.


Condition Intervention Phase
Aphakia
Device: Tecnis MF IOL
Device: Crystalens AO IOL
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of the Tecnis™ Multifocal and Crystalens™ Accommodating Intraocular Lenses

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 ]

Enrollment: 40
Study Start Date: March 2010
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Tecnis MF IOL Device: Tecnis MF IOL
20 patients enrolled with the Tecnis MF IOL.
Active Comparator: Crystalens AO IOL Device: Crystalens AO IOL
20 patients enrolled with the Crystalens AO

  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 20/25 or better in each eye after cataract removal and IOL implantation
  • Preoperative best-corrected distance visual acuity (BCDVA) worse than 20/40 Snellen
  • Naturally dilated pupil size (in dim light) > 4.0 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 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: NCT01061281

Locations
United States, Florida
Farrell Tyson
Cape Coral, Florida, United States
Sponsors and Collaborators
Innovative Medical
  More Information

No publications provided

Responsible Party: Farrell Tyson, Cape Coral Eye Center
ClinicalTrials.gov Identifier: NCT01061281     History of Changes
Other Study ID Numbers: Tecnis MF/Crystalens
Study First Received: February 1, 2010
Last Updated: January 13, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Innovative Medical:
Aphakia following refractive lensectomy to treat presbyopia

Additional relevant MeSH terms:
Aphakia
Lens Diseases
Eye Diseases

ClinicalTrials.gov processed this record on August 20, 2014