Visual Function With Contralateral AcrySof® ReSTOR® Aspheric SN6AD1 and SN6AD3

Cataract Clinical Trial

Official title:

Visual Function With Contralateral AcrySof® ReSTOR® Aspheric SN6AD1 and SN6AD3

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00710905
• Other study ID #: ALCONsur002.08
• Status: Terminated
• Phase: Phase 4
• First received: July 3, 2008
• Last updated: November 21, 2011
• Start date: October 2009
• Est. completion date: September 2010

Study information

• Verified date: November 2011
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

The objective of this study is to prospectively evaluate the visual parameters in a series of patients after phacoemulsification cataract surgery in a series of patients bilaterally implanted with the AcrySof® ReSTOR® Aspheric Intraocular Lens (IOL) Models SN6AD1 And SN6AD3.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 50
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• Prospective subjects should be 21 years of age and older, be of any race and gender and meet study entry criteria. Subject must require extraction of cataracts followed by implantation of a posterior chamber intraocular lens (IOL). Subjects must be candidates for bilateral removal of the natural crystalline lens followed by implantation of a multifocal IOL and be willing and able to complete all follow-up visits.

Exclusion Criteria:

• Subjects with pre-existing conditions that could skew the results or are contraindications for the AcrySof® ReSTOR® IOL should be excluded from the study. Please consult the AcrySof® ReSTOR® Aspheric product inserts under "Precautions" for subject groups that should be excluded from this study.

• All subjects must have = 0.75 diopters of astigmatism preoperatively as measured by Keratometry (K) readings. If the surgeon determines that a correction of cylinder is necessary postoperatively, this may be performed after the three month evaluations are completed.

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:
• AcrySof ReSTOR Aspheric IOL models SN6AD1 and SN6AD3
Contralateral implantation of AcrySof ReSTOR +3 Intraocular Lens (IOL) in one eye, AcrySof ReSTOR +4 IOL in the other eye following cataract removal.

Locations

Country	Name	City	State
Canada	Dr John Blaylock	Abbotsford	British Columbia
Canada	Dr Dominique Meyer	Quebec City	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Binocular Visual Acuity at Near, Intermediate and Distance	Binocular uncorrected and best corrected visual acuity (VA) was tested at 4 meters (m) (distance), 60 centimeters (cm) (intermediate), and near at preferred distance (distance chosen by each subject and recorded in cm; mean and standard deviation calculated) with a standard ETDRS chart for distance and a hand held chart for near. Scores were calculated using logMAR values. LogMAR is the "logarithm of the minimum angle of resolution". A lower logMAR value indicates better VA.	6 months after surgery	No