Evaluation Of Bilateral Tecnis Multifocal Versus ReSTOR 3D Intraocular Lenses

Cataract Clinical Trial

Official title:

Evaluation Of Bilateral Tecnis Multifocal Versus ReSTOR 3D Intraocular Lenses

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01061918
• Other study ID #: Tecnis MF/Restor
• Status: Completed
• Phase: Phase 4
• First received: February 2, 2010
• Last updated: February 16, 2011
• Start date: August 2009
• Est. completion date: December 2010

Study information

• Verified date: February 2011
• Source: Innovative Medical
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Cataract

Intervention

Device:
• Tecnis MF
20 patients in the Tecnis MF group.
• ReSTOR
20 patients in the ReSTOR group.

Locations

Country	Name	City	State
United States	William Trattler	Miami	Florida
United States	William Lahners	Sarasota	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Innovative Medical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Refraction		1 year	No
Primary	Distance Visual Acuities		1 year	No