MedDRA - Retinitis Pigmentosa H35.5
Conditions
Interventions
Group 1: All patients are treated on one eye, the partner eye is sham treated. Neither the patients nor the physicians know which eye is treated and which eye is sham treated.
The study eye will be t
Sponsors
Universitätsklinikum Tübingen
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. patients with syndromal or non-syndromal RP (autosomal dominant, auto-somal recessive and X-linked) 2. adults of all sexes aged 18 - 80 years 3. BCVA (ETDRS visual acuity) between 0.1 and 0.8 in both eyes with no more than 15 ETDRS letters (3 lines) difference between eyes 4. octopus 900, kinetic visual field a. Visual field area equal to or greater than 75 deg2 (corresponding to an average radius of 5 degrees; stimulus V4e) in both eyes. b. The difference between the two eyes must have a ratio "OD/OS" not less than 0.5 and not more than 2 5. able and willing to give written informed consent for the study
Exclusion criteria
Exclusion criteria: Ophthalmic exclusion criteria: 1. optic neuritis / optical neuropathy. 2. diabetic retinopathy 3. neovascularization of the retina of different genesis 4. condition after retinal artery or vein occlusion 5. condition after retinal detachment or vitreoretinal surgery 6. silicone oil tamponade 7. dry or neovascular AMD 8. macular edema (SD-OCT) 9. glaucoma 10. corneal degeneration affecting visual acuity 11. opacity of refractive media affecting OCT/FP/ophthalmoscopy (lens classification). 12. cataract which, in the opinion of the investigator, may require surgery during the study period 13. aphakia 14. TES therapy in the last 3 months Further exclusion criteria 15. any chronic, non-controllable or unmanaged disease, e.g., but not limited to, cardiac or pulmonary disease, which increases the patient's risk during study participation 16. poor general health that, in the opinion of the investigator, makes it difficult for the patient to reliably participate in visit appointments or to complete therapy 17. mental illnesses such as bipolar disorder, schizo-affective disorder, addictions or dementia 18. neurological diseases such as epilepsy or Parkinson's disease, which may pose a problem for the application of the therapy 19. concurrent participation in other intervention studies or history of study participation, the effects of which may be ongoing 20. active implants (except cochlear implants in a deactivated state) 21. pregnancy or childbearing women of childbearing potential or lactation 22. basic concerns of the investigator that the patient is capable and fit to participate. 23. allergies to the materials used in the TES.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction of area loss in the kinetic visual field (test mark V4e; measured as the difference between baseline and 3-year visit, statistically including all visual field examinations) of the treated eye in relation to the sham-treated eye | — |
Secondary
| Measure | Time frame |
|---|---|
| contrast sensitivity, best corrected visual acuity (BCVA), static visual field, color sense, retinal morphology, number and severity of adverse events, vision-related quality of life | — |
Countries
Germany
Contacts
Public ContactNadine Kahle
Department für Augenheilkunde, Universitätsklinikum Tübingen
Outcome results
None listed