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Who
is eligible for a retinal implant?
Retinal implant clinical
trials are now open for enrollment of candidates affected by a
group of inherited eye diseases known as retinitis pigmentosa
(RP).
These clinical studies
are being conducted by the Doheny Eye Institute at the University
of Southern California Medical Center and other select sites in
the United States. Testing will evaluate the safety and usefulness
of Argus II, the latest model of a retinal prosthesis, in providing
visual function to blind subjects with severe-to-profound RP.
Individuals interested
in enrolling as implant candidates in this clinical trial must
- Have a confirmed
history of retinitis pigmentosa, with remaining visual acuity
of bare light perception or worse in both eyes.
- Have functional
ganglion cells and optic nerve, as determined by a measurable
electrically evoked response or documented light perception.
- Have a history of
prior useful vision.
- Be 50 or older.
- Reside within 2
hours of land transport from a clinical site.
- Be able to communicate
verbally in English.
The study requires
each subject to be followed for at least 3 years, with visits
to the implanting center up to twice a week. Those with optic-nerve
disease, glaucoma, diabetic retinopathy, ocular trauma, or a history
of retinal detachment are not suitable candidates.
For more information,
contact Second Sight at patients@2-sight.com
or 818/833-5027 or go to www.2-sight.com/Patients.htm
These devices are experimental and not yet commercially available.
Extensive, preclinical testing preceded the human implant clinical
trials.
See also Press Releases About the Study
- The Next
Generation of Retinal Implants: FDA Approves Study to Evaluate
an Artificial Retina Intended to Help Patients Blinded by Retinitis
Pigmentosa [ USC
Press Release, 02/15/07]
- Second Sight
announces FDA approval to begin clinical trial to test newest
generation of electronic retinal implant [Second
Sight Press Release, 01/09/07]
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