Visual Function After Implantation of Bilateral AcrySoft ReSTOR Aspheric IOL
1 other identifier
interventional
76
1 country
1
Brief Summary
This study will involve up to 20 bilateral patients per surgeon. Patients will be assessed pre-operatively, and at subsequent visits (following the implantation of the intraocular lens in the second eye) at 1 week, 1 month, 3 months and 6 months post-operatively.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
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
November 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2009
CompletedFirst Submitted
Initial submission to the registry
July 7, 2009
CompletedFirst Posted
Study publicly available on registry
July 8, 2009
CompletedResults Posted
Study results publicly available
May 6, 2010
CompletedMay 6, 2010
May 1, 2010
1.3 years
July 7, 2009
March 25, 2010
May 5, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Visual Acuity
Comparison of visual acuity (measured in logMAR) prior to and following bilateral implantation of the AcrySof ReSTOR Aspheric Intraocular Lens (IOL). Visual parameters were assessed prior to and after the implantation of the second lens at 1 week, 1 month, 3 months, and 6 months. LogMAR, the unit of measure for visual acuity, is the "logarithm of the minimum angle of resolution". A lower logMAR value indicates better visual acuity.
pre-operative;1 week,1 month, 3 months and 6 months after 2nd eye surgery
Secondary Outcomes (1)
Spectacle Independence
pre-op;1 week,1 month,3 months and 6 months after 2nd eye surgery
Study Arms (1)
AcrySof® ReSTOR® Aspheric IOL
EXPERIMENTALAcrySof® ReSTOR® Aspheric Intraocular Lens (IOL)
Interventions
AcrySof® ReSTOR® Aspheric Intraocular Lens (IOL) implanted into the study eye following the cataract extraction surgery
Eligibility Criteria
You may qualify if:
- years or older;
- need spherical correction between 10-30 Diopters (D);
- corneal astigmatism less than 0.75D as measured by keratometry;
- willing to sign an Informed Consent Form and complete all visits;
- pupil dilation greater than 6mm;
- expected Visual Acuity (measured in logMAR)=0.3 or better
You may not qualify if:
- Women of childbearing potential;
- irregular corneal astigmatism;
- keratopathy/keratectasia;
- cornea inflammation or edema;
- cornea reshaping surgery;
- corneal dystrophy;corneal transplant;
- amblyopia;
- glaucoma;
- Retinal Pigment Epitheliopathy (RPE)/Macular changes;
- proliferative diabetic retinopathy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Alcon Researchlead
Study Sites (1)
Alcon Call Center for Trial Locations
Fort Worth, Texas, 76134, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- 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
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
July 7, 2009
First Posted
July 8, 2009
Study Start
November 1, 2007
Primary Completion
March 1, 2009
Last Updated
May 6, 2010
Results First Posted
May 6, 2010
Record last verified: 2010-05