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Clinical Trials/NCT01166971
NCT01166971CompletedPhase 4

A Randomized, Subject-masked Comparison of Visual Function After Bilateral Implantation of Presbyopia-correcting IOLs

Alcon Research6 sites in 1 country65 target enrollmentStarted: July 2010Last updated:
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Conditions

Trial Snapshot

Phase
Phase 4
Status
Completed
Enrollment
65
Locations
6
Primary Endpoint
Defocus Curve
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

The purpose of this study is to prospectively evaluate postoperative visual and refractive parameters in a series of subjects bilaterally implanted with the AcrySof® IQ ReSTOR® +3 versus those bilaterally implanted with the Tecnis Multifocal 1-piece.

Study Design

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

Eligibility Criteria

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

Inclusion Criteria

  • •diagnosed with bilateral cataracts
  • •candidate for presbyopic lens

Exclusion Criteria

  • •>1 Diopter (D) preoperative astigmatism by Keratometry (K)readings
  • •pre-existing conditions that could skew the results

Outcomes

Primary Outcomes

Defocus Curve

Time Frame: 3 months after surgery

A defocus curve is created by multiple measurements of one's visual acuity at different spherical powers (recorded as Diopters (D)). Visual Acuity (VA) is measured in logMAR. LogMAR is the "logarithm of the minimum angle of resolution".

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (6)

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