AMO's Tecnis™ Multifocal Intraocular Lenses (Tecnis MF), Alcon's ReStor Multifocal IOL

Cataract Clinical Trial

Official title:

AMO's Tecnis™ Multifocal Intraocular Lenses (Tecnis MF), Alcon's ReStor Multifocal IOL

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01278420
• Other study ID #: TMF vs Restor MF 3D
• Status: Recruiting
• Phase: Phase 4
• First received: August 27, 2010
• Last updated: June 13, 2012
• Start date: September 2010
• Est. completion date: December 2012

Study information

• Verified date: June 2012
• Source: Innovative Medical
• Contact: Jenna Piel
• Phone: 951-653-5566
• Email: j.piel[@]imedsonline.com
• 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 IOLs Six months post cataract surgery.

Description:

The purpose of this study is to compare the visual outcomes with bilateral implantation of Tecnis MF and ReSTOR IOLs Six months post cataract surgery.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age 18 or greater

• Bilateral condition (cataracts or Presbyopia) for which phacoemulsification 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

• Clear intraocular media other than cataract

• Normal OCT of the macula

• No evidence of Keratoconus or significant irregular astigmatism on Preoperative topography

• No evidence of Epithelial Basement Membrane Dystrophy on Slit lamp Exam

• Availability, willingness, and sufficient cognitive awareness to comply with examination procedures

Exclusion Criteria:

• Use of systemic or ocular medications that may affect vision

• Uncontrolled systemic or ocular disease

• History of ocular trauma

• History of intraocular, extraocular Muscle, or corneal surgery (including laser vision correction)

• 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 20/25 or worse

• Subjects who may be expected to require retinal laser treatment or other surgical intervention (i.e patients with diabetic retinopathy)

• Capsule or zonular abnormalities that may affect postoperative centration or tilt of the lens (e.g. pseudoexfoliation syndrome)

• Contact lens usage within 2 months for PMMA contacts lenses, 2 weeks for gas permeable lenses or 3 days for extended-wear and daily-wear soft contact lenses

Study Design

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

Related Conditions & MeSH terms

• Cataract

Intervention

Device:
• Tecnis MF
30 subjects will be implanted with the Tecnis MF
• ReSTOR
30 subjects will be implanted with ReSTOR

Locations

Country	Name	City	State
United States	Katzen Eye Care & Laser Center	Boynton Beach	Florida
United States	Cleveland Eye Clinic	Breckville	Ohio
United States	Eye Surgeons of Indiana	Indianapolis	Indiana
United States	Jackson Eye, SC	Lake Villa,	Illinois
United States	The Center for Excellence in Eye Care	Miami	Florida
United States	Sansum- Santa Barbara medical foundation Clinic	Santa Barbara	California

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
Primary	Near Visual Acuities		1 year	No
Primary	Intermediate Acuities		1 year	No