Evaluation of the Aspheric ReSTOR IOL After Routine Cataract Extraction

Cataract Clinical Trial

Official title:

Evaluation of the Aspheric ReSTOR IOL After Routine Cataract Extraction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00720005
• Other study ID #: MRC-07-002
• Status: Completed
• Phase: Phase 4
• First received: July 18, 2008
• Last updated: October 1, 2010
• Start date: September 2007
• Est. completion date: December 2008

Study information

• Verified date: October 2010
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 90 Years

Eligibility

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.

Study Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Cataract

Intervention

Device:
• Aspheric Acrysof ReSTOR intraocular lens
Bilateral implantation of Aspheric Acrysof ReSTOR

Locations

Country	Name	City	State
United States	Storm Eye Institute, Medical University of South Carolina	Charleston	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of South Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).		Preoperatively, 1, 3 and 6 months postoperatively	No
Secondary	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.		preoperatively, 1, 3, 6 month	No