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Clinical Trials/NCT00684138
NCT00684138CompletedPhase 4

ACRYSOF® ReSTOR® Aspheric +3.0 D Add Power Intraocular Lens (IOL)

Alcon Research2 sites in 1 country300 target enrollmentStarted: June 2007Last updated:
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Conditions

Trial Snapshot

Phase
Phase 4
Status
Completed
Enrollment
300
Locations
2
Primary Endpoint
Binocular Distance Corrected Near Visual Acuity at Best Distance (That Which Provides the Subject With the Best Vision)
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Participant)

Eligibility Criteria

Ages
21 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Binocular Distance Corrected Near Visual Acuity at Best Distance (That Which Provides the Subject With the Best Vision)

Time Frame: 3 months

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.

Secondary Outcomes

  • 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)

Investigators

Sponsor Class
Industry

Study Sites (2)

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ACRYSOF® ReSTOR® Aspheric +3.0 D Add Power... | Clinical Trial