NCT00345111

Brief Summary

The objective of the research on the Restore Intra Ocular Lens Implant (IOL) is to determine the clinical visual outcomes following bilateral implantation of the IOL compared to a control IOL and to demonstrate what percentage of the subjects obtain spectacle freedom.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2005

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
withdrawn

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

July 1, 2005

Completed
12 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
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

August 16, 2018

Status Verified

August 1, 2018

Enrollment Period

2.4 years

First QC Date

June 23, 2006

Last Update Submit

August 14, 2018

Conditions

Refractive Assessment

Keywords

Restor IOL versus Conventional IOL

Outcome Measures

Primary Outcomes (1)

  • manifest refraction, contrast sensitivity, stereopsis.

Secondary Outcomes (1)

  • near, intermediate and distant visual acuity, life style questionaire and the life style vision evaluation

Interventions

Clinical visual outcomes of bilateral implantation of Restore Intra Ocular Lens.PROCEDURE

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas Southwestern Medical Center at Dallas

Dallas, Texas, 75390-8866, United States

Location

Study Officials

  • R. Wayne Bowman, M.D.

    University of Texas, Southwestern Medical Center at Dallas

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 23, 2006

First Posted

June 27, 2006

Study Start

July 1, 2005

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

August 16, 2018

Record last verified: 2018-08

Locations

US(1)