Instructions for Use
03
Indications / Contraindications
Indications
The TES-Therapy with the OkuStim system is indicated for the treatment of
µ
retinitis pigmentosa (also syndromic, e.g. Usher syndrome)
µ
similar retinal diseases like cone-rod dystrophy or choroideremia
1
Contraindications
The TES-Therapy must not be applied:
µ
in patients with blood vessels with growth processes that could be accelerated by electrical
stimulation, like:
– ocular neovascularization of any origin,
– macular edema,
– artery or vein occlusion,
– diabetic retinopathy,
– age-related macular degeneration.
µ
in patients who have a severe acute or chronic disease according to their medical evalua-
tion (medical, psychiatric, other abnormal clinical findings) that could be worsened by the
therapy.
µ
in patients with active implants
2
,
µ
in case of current pregnancy,
µ
whilst breastfeeding,
µ in case of acute eye inflammation.
Conditions for the application of transcorneal electrical stimulation
therapy are:
µ
Patients’ ability to give consent,
µ Visual acuity of at least light perception,
µ
Patients must be able to sit still for 30 minutes.
1
According to the work group “Clinical Issues” of the German Patient Organization PRO RETINA there are no
objections to treating these diseases with TES. Source: https://www.pro-retina.de/forschungsfoerderung/
wissenschaftliche-beratungsgremien/empfehlungen/bewertung-zur-elektrostimulation-am-auge
2
Patients with cochlear implants can apply the TES-therapy, provided the implant is deactivated and external
components are removed for the duration of the stimulation.
Rev. 2021-07-01
OkuStim
System
TD60K06 -
5 36