ReSTOR Natural +3.0D Study In Japan

Not Applicable

Completed

• Conditions: Cataract
• Interventions: Device: ACRYSOF Multifocal Single-piece Intraocular Lens (IOL) Model SN6AD1

• Registration Number: NCT00758576
• Lead Sponsor: Alcon Research

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-02
• Study First Submitted: 2008-09-23
• Study First Submitted QC: 2008-09-24
• Study First Posted: 2008-09-25
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Results First Submitted: 2010-10-08
• Results First Submitted QC: 2010-11-03
• Status Verified: 2010-12
• Results First Posted: 2010-12-02
• Last Update Submitted: 2010-12-06
• Last Update Posted: 2010-12-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SN6AD1	ACRYSOF Multifocal Single-piece Intraocular Lens (IOL) Model SN6AD1	AcrySof ReSTOR Model SN6AD1 Intraocular Lens

Primary Outcome Measures

Name	Time	Method
Uncorrected Intermediate Visual Acuity	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.
Uncorrected Distance Visual Acuity	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.
Uncorrected Near Visual Acuity	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.

Trial Locations

Locations (1)

Hayashi Eye Hospital; 🇯🇵 Fukuoka, Japan