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

Sponsor
Innovative Medical (Industry)
Overall Status
Completed
CT.gov ID
NCT01061281
Collaborator
(none)
40
Enrollment
1
Location
2
Arms
21
Duration (Months)
1.9
Patients Per Site Per Month

Study Details

Study Description

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
  • Device: Tecnis MF IOL
  • Device: Crystalens AO IOL
 Phase 4

Study Design

Study Type:
Interventional
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 :
Mar 1, 2010
Actual Primary Completion Date :
Dec 1, 2011
Actual Study Completion Date :
Dec 1, 2011

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Refraction [1 year]

  2. Distance Visual Acuities [1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Farrell Tyson Cape Coral Florida United States

Sponsors and Collaborators

  • Innovative Medical

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT01061281
Other Study ID Numbers:
  • Tecnis MF/Crystalens
First Posted:
Feb 3, 2010
Last Update Posted:
Jan 18, 2012
Last Verified:
Jan 1, 2012
Keywords provided by , ,
Aphakia following refractive lensectomy to treat presbyopia
Additional relevant MeSH terms:
Aphakia

Study Results

No Results Posted as of Jan 18, 2012