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Completed

NCT Number: NCT00758576

ReSTOR Natural +3.0D Study In Japan

The objective of this study is to evaluate safety and effectiveness of ACRYSOF Multifocal Single-piece Intraocular Lens (IOL) Model SN6AD1 when implanted to replace the natural lens following cataract removal.

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Key information

Conditions

Cataract Eye Diseases Lens Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hayashi Eye Hospital

Fukuoka, 812-0011, Japan

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Planned bilateral cataract removal by phacoemulsification
  • Potential postoperative best corrected visual acuity of 0.5 or over
  • 1.5 Diopter (D) or less of astigmatism preoperatively, measured by keratometry

Exclusion criteria

  • Poorly controlled glaucoma
  • Progressive diabetic retinopathy

Treatment and study plan

ACRYSOF Multifocal Single-piece Intraocular Lens (IOL) Model SN6AD1

Device

Implantation with the AcrySof ReSTOR Intraocular Lens (IOL) Model SN6AD1 following cataract removal.

Primary outcomes

  1. Uncorrected Intermediate Visual Acuity

    Time frame: 1 year after surgery

    Binocular Uncorrected Intermediate Visual Acuity, measured at 1 meter and 50 centimeters measured in decimal visual acuity. Decimal visual acuity is the normal method to measure visual acuity in Japan. A higher decimal visual acuity value indicates better visual acuity. 0.5 in decimal visual acuity means 20/40 in Snellen fraction.

  2. Uncorrected Distance Visual Acuity

    Time frame: 1 year after surgery

    Binocular Uncorrected Dinstance Visual Acuity measured in decimal visual acuity. Decimal visual acuity is the normal method to measure visual acuity in Japan. A higher decimal visual acuity value indicates better visual acuity. 0.5 in decimal visual acuity means 20/40 in Snellen fraction.

  3. Uncorrected Near Visual Acuity

    Time frame: 1 year after surgery

    Binocular Near Visual Acuity measured in decimal visual acuity. Decimal visual acuity is the normal method to measure visual acuity in Japan. A higher decimal visual acuity value indicates better visual acuity. 0.5 in decimal visual acuity means 20/40 in Snellen fraction.

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Official study title

ReSTOR Natural +3.0D (Diopter) Study In Japan

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Sep 25, 2008
Registry last updated
Dec 21, 2010

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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