Evaluation of the Aspheric ReSTOR IOL A… | Clinical Trial

Key information

Conditions

Cataract Eye Diseases Lens Diseases

Age range

40 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Storm Eye Institute, Medical University of South Carolina

Charleston, South Carolina, 29425, United States

About this study

The purpose of this study is to evaluate the visual outcomes and patient satisfaction after bilateral implantation of the aspheric ReSTOR multifocal intraocular lens (IOL) and compare it to a historical control group of patients implanted bilaterally with the spherical ReSTOR multifocal.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Subject must have an age-related cataract in both eyes.
40 years of age or older.
Patient must desire cataract extraction.
Expected maximum of 2 weeks and minimum of 1-week interval between first and second eye surgeries.
Willing and able to comply with scheduled visits and other study procedures

Exclusion criteria

Preoperative ocular pathology potentially affecting visual acuity.
Keratometric astigmatism exceeding 1.50 diopters.
Planned postoperative refraction for mono-vision.
Uncontrolled diabetes.
Use of any systemic or topical drug known to interfere with visual performance.
Contact lens use during the active treatment portion of the trial.
Any concurrent infectious/non infectious conjunctivitis, keratitis or uveitis.
Pregnant or nursing mothers and females of childbearing potential not practicing a reliable and medically acceptable method of birth control.
Any clinically significant, serious or severe medical or psychiatric condition that may increase the risk associated with study participation or study device implantation or may interfere with the interpretation of study results.
Participation in (or current participation) any investigational drug or device trial within the previous 30 days prior to the start date of this trial.
Intraocular conventional surgery within the past three months or intraocular laser surgery within one month in the operated eye.
Other ocular surgery at the time of the cataract extraction.

Treatment and study plan

Aspheric Acrysof ReSTOR intraocular lens

Device

Bilateral implantation of Aspheric Acrysof ReSTOR

Other names: Acrysof ReSTOR

Primary outcomes

ETDRS uncorrected and best corrected visual acuity at distance, intermediate, and near, manifest refraction, distance corrected near visual acuity (DCNVA), and best near point (optimal reading distance).

Time frame: Preoperatively, 1, 3 and 6 months postoperatively

Secondary outcomes

pupil size and contrast sensitivity under photopic and mesopic conditions wearing the best distance correction (the latter per eye and both eyes. Slit-lamp exam, eye dominance, reading speed test, and a quality of vision questionnaire.

Time frame: preoperatively, 1, 3, 6 month

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Registry information

Important dates

Study start: 2007
Primary completion: 2008
Study completion: 2008
First posted: Jul 22, 2008
Registry last updated: Oct 4, 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.

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Completed