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

Alcon Research3 sites in 1 country65 target enrollmentJuly 2010

ConditionsCataract

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Cataract
Sponsor: Alcon Research
Enrollment: 65
Locations: 3
Primary Endpoint: Defocus Curve
Status: Completed
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

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.

Registry

clinicaltrials.gov

Start Date

July 2010

End Date

March 2011

Last Updated

14 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Alcon Research

Responsible Party

Sponsor

Eligibility Criteria

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".