Visual Function and Patient Satisfaction After Bilateral Implantation of Acrysof Natural Restor (Mod. SN60D3) or Acrysof Natural Monofocal (Mod. SN60AT)

This study is currently recruiting participants.

Verified by Alcon Research, September 2008

Sponsored by:	Alcon Research
Information provided by:	Alcon Research
ClinicalTrials.gov Identifier:	NCT00759668

Purpose

The purpose of the study is:

to compare visual parameters (Subjective refraction and VA) and safety (tilt, decentration and PCO) in a prospective series of 40 patients after bilateral implantation of Acrysof Natural Restor (SN60D3) or Acrysof Natural Monofocal (SN60AT)
to assess patients satisfaction before and after implant

Condition	Intervention
Cataract	Device: Acrysof Natural Restor SN60D3 Device: Acrysof Natural Monofocal SN60AT

MedlinePlus related topics: Cataract

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment

Further study details as provided by Alcon Research:

Primary Outcome Measures:

Changes in visual acuity [ Time Frame: Baseline, 1,3 and 6 months after second implantation ] [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	May 2007
Estimated Study Completion Date:	September 2009
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Intraocular Lens Acrysof Natural Restor SN60D3	Device: Acrysof Natural Restor SN60D3 Intraocular Lens
2: Active Comparator Intraocular Lens Acrysof Natural Monofocal SN60AT	Device: Acrysof Natural Monofocal SN60AT Intraocular Lens

Eligibility

Criteria

Inclusion:

Written informed consent
Age: ≥ 50 years ≤ 75 years
Bilateral age related cataract, to be extracted and followed by the implantation of Posterior chamber IOLs Preop and post op astigmatism ≤ 1D, as from K readings
Potential post op VA ≥ 20/40
Second eye surgery to take place no longer than 45 days after the first implant

Exclusion:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00759668

Contacts

Contact: Alcon Call Center

1-888-451-3937

Locations

United States, Texas
Contact Alcon Call Center for Trial Locations	Recruiting
Fort Worth, Texas, United States, 76134

Sponsors and Collaborators

Alcon Research

More Information

Responsible Party:	Alcon ( Marcello Fornoni )
Study ID Numbers:	IT 06 01
Study First Received:	September 24, 2008
Last Updated:	September 24, 2008
ClinicalTrials.gov Identifier:	NCT00759668
Health Authority:	Italy: The Italian Medicines Agency

Study placed in the following topic categories:

Eye Diseases
Cataract
Lens Diseases

ClinicalTrials.gov processed this record on January 16, 2009