NCT00344578

Brief Summary

To evaluate the clinical outcomes of AcrySof® ReSTOR® IOL for the Faculty Practice at UTSW Medical Center at Dallas

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2006

Geographic Reach
1 country

2 active sites

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

March 1, 2006

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 23, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 27, 2006

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
Last Updated

March 23, 2011

Status Verified

June 1, 2006

Enrollment Period

1.3 years

First QC Date

June 23, 2006

Last Update Submit

March 22, 2011

Conditions

Outcomes Following Restor IOL Lens Implant

Keywords

Higher Order Abberations

Outcome Measures

Primary Outcomes (1)

  • 1)Visual acuity with and without correction of distance and near at 3-6 months

Secondary Outcomes (7)

  • Percent of patients requiring keratorefractive surgery

  • Ocular comorbidity subgroup analysis

  • Monocular implantation subanalysis (prior to LASIK)

  • Comparison of post-op spherical equivalent to target refraction

  • Posterior capsule opacity that may be treated with laser procedure known as a YAG laser capsulotomy?

  • +2 more secondary outcomes

Interventions

Restor IOLDEVICE

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All patients of any race and sex between the ages of 18-90 years of age who have undergone ReSTOR® IOL cataract surgery will be recruited in this retrospective project.

You may qualify if:

  • All patients of any race and sex between the ages of 18-90 years of age who have undergone ReSTOR® IOL cataract surgery will be recruited in this retrospective project.

You may not qualify if:

  • Patients who underwent conventional IOL cataract extraction surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Aston Ambulatory Care Center

Dallas, Texas, 75390-8866, United States

Location

UTSW Medical Center at Dallas

Dallas, Texas, 75390, United States

Location

Study Officials

  • Adam Fedyk, MD

    UTSW Medical Center at Dallas

    PRINCIPAL INVESTIGATOR

  • Vinod Mootha, MD

    UTSW Medical Center at Dallas

    STUDY DIRECTOR

  • James McCulley, MD

    UTSW Medical Center at Dallas

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 23, 2006

First Posted

June 27, 2006

Study Start

March 1, 2006

Primary Completion

July 1, 2007

Study Completion

July 1, 2007

Last Updated

March 23, 2011

Record last verified: 2006-06

Locations

US(2)