Evaluation of the Aspheric ReSTOR IOL After Routine Catar... | NCT00720005

Studies
Evaluation of the Aspheric ReSTOR IOL After Routine Cataract Extraction

NCT00720005

Sponsor

Medical University of South Carolina

Status

Completed

Last Update Posted

Oct 4, 2010Estimated

Enrollment

20Actual

Phase

Not provided

Conditions

Cataract

Interventions

Aspheric Acrysof ReSTOR intraocular lens

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2007

Primary Completion Date

Dec 2008Actual

Completion Date

Dec 2008Actual

First Submitted Date

Jul 18, 2008

First Submission Date that Met QC Criteria

Jul 21, 2008

First Posted Date

Jul 22, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 1, 2010

Last Update Posted Date

Oct 4, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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

Detailed Description

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Aspheric Acrysof ResTOR Lens		Implantation of Aspheric Acrysof ResTOR	Device: Aspheric Acrysof ReSTOR intraocular lens

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Aspheric Acrysof ReSTOR intraocular lens	Device	Bilateral implantation of Aspheric Acrysof ReSTOR	Aspheric Acrysof ResTOR Lens

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Subjects 18 years or older who had cataract surgery.

Sampling Method

Probability Sample

ID	Term
D007905	Lens Diseases
D005128	Eye Diseases