Visual Function After Implantation of Bilateral AcrySof ReSTOR Aspheric Intraocular Lens (IOL): Postmarket Evaluation

Alcon Research1 site in 1 country34 target enrollmentDecember 2008

ConditionsCataracts

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Cataracts
Sponsor: Alcon Research
Enrollment: 34
Locations: 1
Primary Endpoint: Uncorrected and Best Corrected Visual Acuities (Near and Distance)
Status: Completed
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The objective of this study is to evaluate postoperative visual function in patients implanted bilaterally with the ReSTOR Aspheric Intraocular Lens (IOL).

Registry

clinicaltrials.gov

Start Date

December 2008

End Date

July 2009

Last Updated

15 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Alcon Research

Eligibility Criteria

Inclusion Criteria

•Bilateral cataract patients who require natural crystalline lens removal and bilateral Intraocular Lens (IOL) implantation.
•50\~75 years of age
•\<1 Diopter of astigmatism preoperatively (before surgery) as measured by Keratometry readings.

Exclusion Criteria

•Patients with pre-existing conditions that could skew the results.
•Any of conditions before and during surgery specified in the product information.

Outcomes

Primary Outcomes

Uncorrected and Best Corrected Visual Acuities (Near and Distance)

Time Frame: 6 Months Following Cataract Surgery

Measurement of uncorrected (without spectacles or other visual corrective devices) and best-corrected (with spectacles or other visual corrective devices)visual acuity at both near and distance. Visual Acuity (VA) is measured in logMAR. LogMAR is the "logarithm of the minimum angle of resolution". A lower logMAR value indicates better visual acuity.