Evaluation of the effectiveness of transcorneal electrostimulation in patients with retinitis pigmentosa - a multicenter, prospective, randomized, controlled and double-blind study on behalf of the G-BA

Phase 4

• Conditions: MedDRA - Retinitis Pigmentosa; H35.5; Hereditary retinal dystrophy

• Registration Number: DRKS00023562
• Lead Sponsor: niversitätsklinikum Tübingen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-02-18
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 141

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

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.

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
contrast sensitivity,<br>best corrected visual acuity (BCVA),<br>static visual field, <br>color sense, <br>retinal morphology, <br>number and severity of adverse events,<br>vision-related quality of life