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Evaluation Of Bilateral Tecnis Multifocal Versus ReSTOR 3D Intraocular Lenses

Sponsor
Innovative Medical (Industry)
Overall Status
Completed
CT.gov ID
NCT01061918
Collaborator
(none)
40
Enrollment
2
Locations
2
Arms
16
Duration (Months)
20
Patients Per Site
1.3
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 ReSTOR intraocular lenses (IOLs) 6 months post cataract surgery.

Condition or Disease Intervention/Treatment Phase
  • Device: Tecnis MF
  • Device: ReSTOR
 Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Official Title:
Evaluation Of Bilateral Tecnis Multifocal Versus ReSTOR 3D Intraocular Lenses
Study Start Date :
Aug 1, 2009
Actual Primary Completion Date :
Dec 1, 2010
Actual Study Completion Date :
Dec 1, 2010

Arms and Interventions

Arm Intervention/Treatment
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.

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 20/30 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

Locations

Site City State Country Postal Code
1 William Trattler Miami Florida United States 33176
2 William Lahners Sarasota Florida United States 34239

Sponsors and Collaborators

  • Innovative Medical

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT01061918
Other Study ID Numbers:
  • Tecnis MF/Restor
First Posted:
Feb 3, 2010
Last Update Posted:
Feb 17, 2011
Last Verified:
Feb 1, 2011
Keywords provided by , ,
Compare the visual outcomes with bilateral implantation of Tecnis MF and ReSTOR IOLs 6 months post cataract surgery.
Additional relevant MeSH terms:
Cataract

Study Results

No Results Posted as of Feb 17, 2011