Visual Function With Bilateral AcrySof® ReSTOR® Aspheric SN6AD1

NCT00710931 | Completed Phase 4 Results

• 1 other identifier: ALCONsur001.08
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief 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 +3.0 Intraocular Lens (IOL).

Conditions

Cataract

Keywords

Bilateral Cataract; IOL; ReSTOR; Aspheric

Outcome Measures

Primary Outcomes (1)

• Binocular Visual Acuity at Distance, Near and Intermediate

  Uncorrected and best corrected visual acuity (VA) was tested at 4 meters (m), 60 centimeters (cm), 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. VA is measured in logMAR. LogMAR is the "logarithm of the minimum angle of resolution". A lower logMAR value indicates better VA.

  6 months after surgery

Study Arms (1)

ReSTOR +3 Multifocal Lens

EXPERIMENTAL

Bilateral implantation of the AcrySof ReSTOR +3 Intraocular Lens (IOL)

Device: AcrySof ReSTOR Aspheric IOL model SN6AD1

Interventions

AcrySof ReSTOR Aspheric IOL model SN6AD1 DEVICE

Bilateral implantation of the AcrySof ReSTOR +3 Intraocular Lens (IOL) following cataract removal.

ReSTOR +3 Multifocal Lens

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alcon Research: lead

Study Sites (1)

Contact Alcon Call Center for Trial Locations

Fort Worth, Texas, 76134, United States

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Results Point of Contact

• Title: Director of Alcon Clinical
• Organization: Alcon Research, Ltd.

medinfo@alconlabs.com

888.451.3937; 817.568.6725

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2008
• First Posted: July 8, 2008
• Study Start: October 1, 2008
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: December 12, 2011
• Results First Posted: November 8, 2011

Record last verified: 2011-12

Locations

US (1)