Visual Function Evaluation of Bilateral AcrySof ReSTOR Aspheric IOL

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

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Key information

Conditions

Cataracts Cataract Eye Diseases Lens Diseases

Age range

50 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Alcon Call Center for Trial Locations

Fort Worth, Texas, 76134, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

AcrySof ReSTOR Aspheric IOL

Device

Bilateral implantation with the AcrySof ReSTOR Aspheric Intraocular Lens (IOL) for the replacement of cataract in the natural lens of the eye.

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.

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Official study title

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

Important dates

Study start: 2008
Primary completion: 2009
First posted: Jan 7, 2009
Registry last updated: Jul 30, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed