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Completed

NCT Number: NCT00710931

Visual Function With Bilateral AcrySof® ReSTOR® Aspheric SN6AD1

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).

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Key information

Conditions

Cataract Eye Diseases Lens Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Contact Alcon Call Center for Trial Locations

Fort Worth, Texas, 76134, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

AcrySof ReSTOR Aspheric IOL model SN6AD1

Device

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

Primary outcomes

  1. Binocular Visual Acuity at Distance, Near and Intermediate

    Time frame: 6 months after surgery

    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.

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Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Jul 8, 2008
Registry last updated
Dec 12, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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