Phase 4 N=132 Randomized Single-blind Treatment

Presbyopia-Correcting Intraocular Lenses (IOLs)

Cataract

Bottom Line

View on ClinicalTrials.gov: NCT00963560 ↗

Enrolled (actual)

132

Serious AEs

0.0%

Results posted

Aug 2011

Primary outcome: Primary: Best Corrected Visual Acuity — -0.075; -0.080; -0.081; 0.227 logMAR

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: ReSTOR +3 (Device); Crystalens HD (Device); Crystalens AO (Device)
Age: Adult, Older Adult · 21+ yrs
Sex: All
Sponsor: Alcon Research
Primary completion: Mar 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Best Corrected Visual Acuity	-0.075; -0.080; -0.081; 0.227; 0.176; 0.200	—

Summary

The purpose of this study is to prospectively evaluate postoperative visual and refractive parameters in a series of subjects bilaterally implanted with Presbyopia-Correcting Intraocular Lenses (IOLs).

Eligibility Criteria

Inclusion Criteria

diagnosed with bilateral cataracts
candidate for presbyopic lens

Exclusion Criteria

> 1 Diopter preoperative astigmatism by Keratometry readings
pre-existing conditions that could skew the results

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Data sourced from ClinicalTrials.gov (NCT00963560). 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.