ACRYSOF® ReSTOR® Aspheric +3.0 D Add Power Intraocular Lens (IOL)
1 other identifier
interventional
300
1 country
1
Brief Summary
Randomized, parallel group, subject masked, multi-center six (6) month follow-up study comparing ACRYSOF® ReSTOR® Aspheric +3.0 D Add Power IOL Model SN6AD1 implanted in both eyes to ACRYSOF® ReSTOR® Aspheric +4.0 D Add Power IOL Model SN6AD3 implanted in both eyes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jun 2007
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2007
CompletedFirst Submitted
Initial submission to the registry
May 22, 2008
CompletedFirst Posted
Study publicly available on registry
May 26, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2008
CompletedResults Posted
Study results publicly available
March 11, 2010
CompletedJuly 13, 2010
July 1, 2010
1 year
May 22, 2008
January 30, 2009
July 6, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Binocular Distance Corrected Near Visual Acuity at Best Distance (That Which Provides the Subject With the Best Vision)
Binocular Distance Corrected Near Visual Acuity at Best Distance (that which provides the subject with the best vision)measured in mean logMAR. logMAR is the logarithm of the minimum angle of resolution, which is a measure for visual acuity (VA). Mean logMAR is the average value of visual acuity.
3 months
Secondary Outcomes (4)
Binocular Distance Corrected Distance Visual Acuity
3 months post-operative
Binocular Distance Corrected Intermediate Visual Acuity (Tested at 50 cm)
3 months post-operative
Binocular Distance Corrected Intermediate Visual Acuity (Tested at 60 cm)
3 months post-operative
Binocular Distance Corrected Intermediate Visual Acuity (Tested at 70 cm)
3 months post-operative
Study Arms (2)
ReSTOR Aspheric +3.0D
EXPERIMENTALACRYSOF® ReSTOR® Aspheric +3.0 D Add Power Intraocular Lens
ReSTOR Aspheric +4.0D
ACTIVE COMPARATORACRYSOF® ReSTOR® Aspheric +4.0 D Add Power Intraocular Lens
Interventions
Intraocular Lens
Intraocular Lens
Eligibility Criteria
You may qualify if:
- Adults, 21 years of age or older at the time of surgery, of either gender or any race, diagnosed with bilateral cataracts
- Calculated lens power is within the available range
- Willing and able to complete all required postoperative visits
- Planned cataract removal by phacoemulsification and/or liquifacture
- Potential postoperative visual acuity of 0.2 logMAR or better in study eyes
- Preoperative astigmatism of 1.0 Diopter (D) or less, measured by keratometry in study eyes
- Clear intraocular media other than cataract in study eyes
- Able to comprehend and sign a statement of informed consent
- Preoperative Best Corrected Distance Visual Acuity (BCDVA) worse than 0.2 logMAR, or if BCDVA is equal to or better than 0.2 logMAR, BCDVA with a Brightness Acuity Tester (BAT) on "Medium" setting must be worse than 0.2 logMAR
You may not qualify if:
- Significant irregular corneal aberration as demonstrated by corneal topography
- Subjects with diagnosed degenerative visual disorders (e.g., macular degeneration or other retinal disorders) that are predicted to cause future acuity losses to a level worse than 0.2 logMAR
- Subjects who may reasonably be expected to require laser treatments at any time
- Previous corneal refractive surgery
- Amblyopia
- Clinically severe corneal dystrophy (e.g., epithelial, stromal, or endothelial dystrophy)
- Diabetic retinopathy
- Extremely shallow anterior chamber, not due to swollen cataract
- Microphthalmos
- Previous retinal detachment
- Previous corneal transplant
- Recurrent severe anterior or posterior segment inflammation of unknown etiology
- Rubella or traumatic cataract
- Iris neovascularization
- Glaucoma (uncontrolled or controlled with medication)
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Alcon Researchlead
Study Sites (1)
Call Center for Locations
Fort Worth, Texas, 76134, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Data from one investigator, who implanted 20 subjects, were excluded from analysis due to non compliance with data collection and documentation. This resulted in 280 implanted subjects that were considered evaluable.
Results Point of Contact
- Title
- Alcon Clinical
- Organization
- Alcon Research, Ltd.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
May 22, 2008
First Posted
May 26, 2008
Study Start
June 1, 2007
Primary Completion
June 1, 2008
Study Completion
June 1, 2008
Last Updated
July 13, 2010
Results First Posted
March 11, 2010
Record last verified: 2010-07