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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
History of Changes
  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
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 May 23, 2013