ReSTOR Natural +3.0D Study In Japan

Cataract Clinical Trial

Official title:

ReSTOR Natural +3.0D (Diopter) Study In Japan

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00758576
• Other study ID #: C-07-44
• Status: Completed
• Phase: N/A
• First received: September 23, 2008
• Last updated: December 6, 2010
• Start date: February 2008
• Est. completion date: December 2009

Study information

• Verified date: December 2010
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cataract

Intervention

Device:
• ACRYSOF Multifocal Single-piece Intraocular Lens (IOL) Model SN6AD1
Implantation with the AcrySof ReSTOR Intraocular Lens (IOL) Model SN6AD1 following cataract removal.

Locations

Country	Name	City	State
Japan	Hayashi Eye Hospital	Fukuoka

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Uncorrected Intermediate Visual Acuity	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.	1 year after surgery	Yes
Primary	Uncorrected Distance Visual Acuity	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.	1 year after surgery	Yes
Primary	Uncorrected Near Visual Acuity	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.	1 year after surgery	Yes