ReSTOR Natural +3.0D Study In Japan
ReSTOR Natural +3.0D (Diopter) Study In Japan
1 other identifier
interventional
64
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2008
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2008
CompletedFirst Submitted
Initial submission to the registry
September 23, 2008
CompletedFirst Posted
Study publicly available on registry
September 25, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedResults Posted
Study results publicly available
December 2, 2010
CompletedDecember 21, 2010
December 1, 2010
1.8 years
September 23, 2008
October 8, 2010
December 6, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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
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
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
Study Arms (1)
SN6AD1
EXPERIMENTALAcrySof ReSTOR Model SN6AD1 Intraocular Lens
Interventions
Implantation with the AcrySof ReSTOR Intraocular Lens (IOL) Model SN6AD1 following cataract removal.
Eligibility Criteria
You may qualify if:
- Planned bilateral cataract removal by phacoemulsification
- Potential postoperative best corrected visual acuity of 0.5 or over
- Diopter (D) or less of astigmatism preoperatively, measured by keratometry
You may not qualify if:
- Poorly controlled glaucoma
- Progressive diabetic retinopathy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Alcon Researchlead
Study Sites (1)
Hayashi Eye Hospital
Fukuoka, Fukuoka, 812-0011, Japan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Director of Alcon Clinical
- Organization
- Alcon Research, Ltd.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 23, 2008
First Posted
September 25, 2008
Study Start
February 1, 2008
Primary Completion
December 1, 2009
Study Completion
December 1, 2009
Last Updated
December 21, 2010
Results First Posted
December 2, 2010
Record last verified: 2010-12