Retinitis Pigmentosa
Conditions
Keywords
Transcorneal Electrostimulation, TcES, TES, Inherited retinal dystrophy, Retinopathia pigmentosa, Retinitis pigmentosa
Brief summary
In this retrospective non-interventional study (NIS), the subjective and objective benefit of patients with retinitis pigmentosa (and other dystrophies like Usher, Choroideremia or cone-rod dystrophy), who have been prescribed the therapy of transcorneal electrostimulation (TcES) with the OkuStim System, is assessed.
Detailed description
The medical device OkuStim received the CE mark (a symbol of free marketability in the European Economic Area) in 2011 and is commercially available for patients in Europe since 2014. Since then, patients with retinitis pigmentosa and other dystrophies have regularly applied the therapy of transcorneal electrostimulation (TcES) with OkuStim. So far, the benefits of the therapy and the experiences of the patients with regular, multi-year use have not been systematically recorded. In this retrospective non-interventional study (NIS) with patients which have been using TcES since \>1 year, data present for visual field, best-corrected visual acuity (BCVA) and central foveal thickness (as assessed via OCT) is collected. In addition, reasons for discontinuation of therapy and patient satisfaction with TcES are assessed via a questionnaire. Side-effects are also recorded, if present in the patient files.
Interventions
DEVICETranscorneal Electrostimulation via OkuStim System
Transcorneal electrostimulation, usually applied once per week for 30 min (home-use).
Sponsors
CONET GmbH - Clinical Operations Network
Okuvision GmbH
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Use of TcES for \>1year * Willing and able to consent
Exclusion criteria
* Not willing and able to consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual field | Baseline and then all data present in patient files after begin of therapy. Depending on how long the patient already uses OkuStim, the time frame varies between 1 year and several years after commencement of therapy. | Assessment of changes compared to baseline (before TcES was started) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Best-corrected visual acuity | Baseline and then all data present in patient files after begin of therapy. Depending on how long the patient already uses OkuStim, the time frame varies between 1 year and several years after commencement of therapy. | Assessment of changes compared to baseline (before TcES was started) |
| Central foveal thickness | Baseline and then all data present in patient files after begin of therapy. Depending on how long the patient already uses OkuStim, the time frame varies between 1 year and several years after commencement of therapy. | Assessment of changes compared to baseline (before TcES was started) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Reasons for discontinuation of therapy and patient satisfaction | Patients are asked to fill out the questionnaire once. Depending on how long the patient already uses OkuStim, the time frame varies between 1 year and several years after commencement of therapy | Custom-made questionnaire to assess reasons for discontinuation of therapy and patient satisfaction |
| Adverse events | All data present in patient files after begin of therapy. Depending on how long the patient already uses OkuStim, the time frame varies between 1 year and several years after commencement of therapy. | Adverse events will be recorded if present in the patient files. Only device-related adverse events will be analyzed |
Countries
Germany, Switzerland
Outcome results
None listed