Status:
WITHDRAWN
ACRYSOF® Restor Apodized Diffractive IOL Postmarket Evaluation of Clinical Outcomes and Life-Style Visual Performance RESTOR IOL SN60WF IOL (Control Group)
Lead Sponsor:
University of Texas Southwestern Medical Center
Conditions:
Refractive Assessment
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
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 d...
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 surger...
Eligibility Criteria
Inclusion
- 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
- 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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Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00345111
Start Date
July 1 2005
End Date
December 1 2007
Last Update
August 16 2018
Active Locations (1)
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1
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, United States, 75390-8866