Phase 4 N=42 Randomized Single-blind Treatment

Visual Outcomes of Subjects Bilaterally Implanted With ReSTOR Aspheric +4 vs. Tecnis or Acri.LISA

Cataract

Bottom Line

View on ClinicalTrials.gov: NCT00721253 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2010

Primary outcome: Primary: Uncorrected Visual Acuity (UCVA) at Distance, Near and Intermediate — 0.02; 0.01; 0.20; 0.20 logMAR

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: ReSTOR (Device); Tecnis (Device); Acri.LISA (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Alcon Research
Primary completion: Oct 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Uncorrected Visual Acuity (UCVA) at Distance, Near and Intermediate	0.02; 0.01; 0.20; 0.20; 0.21; 0.19	—
SECONDARY Contrast Sensitivity	1.88; 1.78; 1.98; 2.01; 1.94; 1.99	—
SECONDARY Defocus Curve	0.55; 0.58; 0.38; 0.42; 0.24; 0.27	—

Summary

This is a study to compare visual outcomes of subjects bilaterally implanted w/ReSTOR to subjects bilaterally implanted with the Tecnis Multifocal Intraocular Lens (IOL) or Acri.LISA IOL

Eligibility Criteria

Inclusion Criteria

Diagnosed with cataracts

Exclusion Criteria

Preexisting condition likely to confound results; 1 D astigmatism by preoperative K-readings

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Data sourced from ClinicalTrials.gov (NCT00721253). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.