Phase 4 N=76 Randomized Treatment

Visual Function After Implantation of Bilateral AcrySoft ReSTOR Aspheric IOL

Cataract

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View on ClinicalTrials.gov: NCT00934622 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2010

Primary outcome: Primary: Visual Acuity — 0.54; 0.06; 0.03; 0.04 logMAR

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: AcrySof® ReSTOR® Aspheric IOL (Device)
Age: Adult, Older Adult · 21+ yrs
Sex: All
Sponsor: Alcon Research
Primary completion: Mar 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Visual Acuity	0.54; 0.06; 0.03; 0.04; 0.05	—
SECONDARY Spectacle Independence	29; 96.8; 97.2; 98.6; 100	—

Summary

This study will involve up to 20 bilateral patients per surgeon. Patients will be assessed pre-operatively, and at subsequent visits (following the implantation of the intraocular lens in the second eye) at 1 week, 1 month, 3 months and 6 months post-operatively.

Eligibility Criteria

Inclusion Criteria

21 years or older;
need spherical correction between 10-30 Diopters (D);
corneal astigmatism less than 0.75D as measured by keratometry;
willing to sign an Informed Consent Form and complete all visits;
pupil dilation greater than 6mm;
expected Visual Acuity (measured in logMAR)=0.3 or better

Exclusion Criteria

Women of childbearing potential;
irregular corneal astigmatism;
keratopathy/keratectasia;
cornea inflammation or edema;
cornea reshaping surgery;
corneal dystrophy;corneal transplant;
amblyopia;
glaucoma;
Retinal Pigment Epitheliopathy (RPE)/Macular changes;
proliferative diabetic retinopathy

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00934622). 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.