ACRYSOF® Restor Apodized Diffractive IOL Postmarket Evaluation of Clinical Outcomes and Life-Style Visual Performance RESTOR IOL SN60WF IOL (Control Group)

NCT ID: NCT00345111

Last Updated: 2018-08-16

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-07-31
• Study Completion Date: 2007-12-31

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.

Detailed Description

The Acusof Restor IOL has recently been FDA approved. This research will be an indicator by comparison to a conventional implant lens used for catract surgery. The standard of care for cataract surgery is to implant an IOL to allow the patient distant vision only. As a result, the patient is forced to wear reading glasses or magnifying glasses for near work. With the Restore IOL implant, the patient will have the ability to be corrected for not only distance vision but for near and intermediate visual needs. With FDA approval, the statistical indications demonstate 80% of patients tested in clinical trials did not have the need for use of glasses after cataract surgery. This research will further confirm and quantify the data already submitted by comparing the control group with the Restore Group in this Phase IV project.

The control group of subjects will be patients who have already had cataract surgery in both eyes approximately 6 months prior to entering the study. These individuals will be tested only for the 6 month evaluation in both eyes, including the following tests (manifest refraction, which determines the best vision correction possible, the near, intermediate and distant visual acuity will be assessed at the respective ranges of distance. contrast sensitivity will be determined by choosing the circles that have lines in them opposed to the ones that don't (further assessing visual acuity), stereopsis which indicates whether both eyes are functioning together, pupilometry which measures the pupil diameter, the life style questionaire and the life style vision evaluation form as well.

The Restore IOl group of subjects' post operative visual acuity data will be compared to the control subjects' post operative visual data results at the distance, near, and intermediate ranges, as well as all the other testing required at the sixxth month time frame listed above. The testing will require approximately 2 hours for the 6 month visit for both control and Restore groups.

The Restore group of subjects will have 4 other visits. The pre operative visit will take avout 2 hours and include the following tests: Manifest refraction, near, inermediate, and distance visual acuity testing, life style questionnaire, and obtaining informed consent. The 1 week and 1 month post-operative visit will include manifest refraction, near, intermediate, and distance visual acuity assessment.

Conditions

Refractive Assessment

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

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

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

-

Exclusion Criteria

-

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Texas Southwestern Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

R. Wayne Bowman, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Texas, Southwestern Medical Center at Dallas

Locations

University of Texas Southwestern Medical Center at Dallas

Dallas, Texas, United States

Countries

United States

Other Identifiers

062005-060

Identifier Type: -

Identifier Source: org_study_id