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

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ClinicalTrials.gov Identifier: NCT01061281
Recruitment Status : Completed
First Posted : February 3, 2010
Last Update Posted : January 18, 2012
Information provided by:
Innovative Medical

Brief Summary:
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 or disease Intervention/treatment Phase
Aphakia Device: Tecnis MF IOL Device: Crystalens AO IOL Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of the Tecnis™ Multifocal and Crystalens™ Accommodating Intraocular Lenses
Study Start Date : March 2010
Primary Completion Date : December 2011
Study Completion Date : December 2011

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Refraction [ Time Frame: 1 year ]
  2. Distance Visual Acuities [ Time Frame: 1 year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01061281

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

Responsible Party: Farrell Tyson, Cape Coral Eye Center
ClinicalTrials.gov Identifier: NCT01061281     History of Changes
Other Study ID Numbers: Tecnis MF/Crystalens
First Posted: February 3, 2010    Key Record Dates
Last Update Posted: January 18, 2012
Last Verified: January 2012

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

Additional relevant MeSH terms:
Lens Diseases
Eye Diseases