NCT00565695

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 IOL.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2007

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 29, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 30, 2007

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
Last Updated

October 4, 2010

Status Verified

October 1, 2010

First QC Date

November 29, 2007

Last Update Submit

October 1, 2010

Conditions

Cataract ExtractionRefractive Surgery

Keywords

Visual OutcomesPatient SatisfactionCataract Extraction

Interventions

aspheric ReSTOR multifocal intraocular lens (IOL)DEVICE

Multifocal intraocular lens

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

aspheric ReSTOR multifocal intraocular lens (IOL)

You may qualify if:

  • Subjects MUST fulfill the following conditions to qualify for enrollment into the trial
  • Subject must have an age-related cataract in both eyes.
  • 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.

You may not qualify if:

  • Preoperative ocular pathology:
  • Amblyopia
  • Rubella cataract
  • Proliferative diabetic retinopathy
  • Shallow anterior chamber
  • Macular edema
  • Retinal detachment
  • Aniridia or iris atrophy
  • Uveitis
  • History of iritis
  • Iris neovascularization
  • Medically uncontrolled glaucoma
  • Microphthalmus or macrophthalmus
  • Optic nerve atrophy
  • Macular degeneration (with anticipated best postoperative visual acuity less than 20/30)
  • +13 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Patient Satisfaction

Condition Hierarchy (Ancestors)

Treatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Kerry D Solomon, MD

    Medical University of South Carolina, Storm Eye Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 29, 2007

First Posted

November 30, 2007

Study Start

October 1, 2007

Study Completion

September 1, 2008

Last Updated

October 4, 2010

Record last verified: 2010-10

Locations

US(1)