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

This study has been withdrawn prior to enrollment.
(Verified with former investigator that recruitment activity did not take place)
Sponsor:
Information provided by:
University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT00345111
First received: June 23, 2006
Last updated: September 26, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention Phase
Refractive Assessment
Procedure: Clinical visual outcomes of bilateral implantation of Restore Intra Ocular Lens.
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: ACRYSOF® Restor Apodized Diffractive IOL Postmarket Evaluation of Clinical Outcomes and Life-Style Visual Performance With RESTOR IOL Compared With SN60WF IOL (Control Group)

Further study details as provided by University of Texas Southwestern Medical Center:

Primary Outcome Measures:
  • manifest refraction, contrast sensitivity, stereopsis.

Secondary Outcome Measures:
  • near, intermediate and distant visual acuity, life style questionaire and the life style vision evaluation

Enrollment: 0
Study Start Date: July 2005
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria: 70 years of age or younger; any race; either gender; diagnosis of cataracts both eyes; pre-existing physical conditions that could skew visual results, such as Diabetes, Retinal detachment, Macular degeneration, or Cancer; subjects must have < 1.00 diopter of astigmatism; biometry results for the Restore patients should target emmetropia or +0.25.

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Exclusion Criteria: Over 70 years old; other procedures needed at the time of surgery besides cataract extraction; Sulcus-Sulcus or Bag-Sulcus fixation during surgery; Capsulothexis edge not covering optic edge 360 degrees around; Capsular Rupture; vitreous loss; capsularhexis tear; significant anterior chamber hyphema; Zonular rupture.

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  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00345111

Locations
United States, Texas
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, United States, 75390-8866
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
Principal Investigator: R. Wayne Bowman, M.D. University of Texas Southwestern Medical Center at Dallas
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00345111     History of Changes
Other Study ID Numbers: 062005-060
Study First Received: June 23, 2006
Last Updated: September 26, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Texas Southwestern Medical Center:
Restor IOL versus Conventional IOL

ClinicalTrials.gov processed this record on October 01, 2014