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

NCT00710905 | Terminated Phase 4 Results

• 1 other identifier: ALCONsur002.08
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

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 Intraocular Lens (IOL) Models SN6AD1 And SN6AD3.

Conditions

Cataract

Keywords

Cataract IOL ReSTOR Aspheric; Bilateral cataract

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

ReSTOR

EXPERIMENTAL

Contralateral implantation of AcrySof ReSTOR +3 Intraocular Lens (IOL) in one eye, Acrysof ReSTOR +4 IOL in the other eye.

Device: AcrySof ReSTOR Aspheric IOL models SN6AD1 and SN6AD3

Interventions

AcrySof ReSTOR Aspheric IOL models SN6AD1 and SN6AD3 DEVICE

Contralateral implantation of AcrySof ReSTOR +3 Intraocular Lens (IOL) in one eye, AcrySof ReSTOR +4 IOL in the other eye following cataract removal.

ReSTOR

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 (2)

Dr John Blaylock

Abbotsford, British Columbia, V2S 5A1, Canada

Location

Dr Dominique Meyer

Québec, Quebec, G1S 1X6, Canada

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

Study Officials

• John Blaylock

  PRINCIPAL INVESTIGATOR

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, 2009
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: November 24, 2011
• Results First Posted: November 8, 2011

Record last verified: 2011-11

Locations

CA (2)