Clinical Trial Details
— Status: Withdrawn
Administrative data
| NCT number |
NCT00345111 |
| Other study ID # |
062005-060 |
| Secondary ID |
|
| Status |
Withdrawn |
| Phase |
Phase 4
|
| First received |
|
| Last updated |
|
| Start date |
July 2005 |
| Est. completion date |
December 2007 |
Study information
| Verified date |
August 2018 |
| Source |
University of Texas Southwestern Medical Center |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
