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NCT Number: NCT04983914

Retrospective NIS to Evaluate the Patient Benefit of TES

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.

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Key information

Conditions

Retinitis Pigmentosa Congenital, Hereditary, and Neonatal Diseases and Abnormalities Eye Diseases Eye Diseases, Hereditary Genetic Diseases, Inborn Retinal Degeneration Retinal Diseases Retinal Dystrophies

Sex eligibility

All sexes

Study type

Observational

Primary location

Universitätsklinikum Heidelberg, Augenklinik, Heidelberg, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Use of TcES for >1year
  • Willing and able to consent

Exclusion criteria

  • Not willing and able to consent

Treatment and study plan

Transcorneal Electrostimulation via OkuStim System

Device

Transcorneal electrostimulation, usually applied once per week for 30 min (home-use).

Other names: TcES, TES, OkuStim

Primary outcomes

  1. Visual field

    Time frame: 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 outcomes

  1. Best-corrected visual acuity

    Time frame: 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)

  2. Central foveal thickness

    Time frame: 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 outcomes

  1. Reasons for discontinuation of therapy and patient satisfaction

    Time frame: 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

  2. Adverse events

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Okuvision GmbH

Industry

Collaborators

  • CONET GmbH - Clinical Operations Network

Registry information

Official study title

Retrospective Non-Interventional Study to Evaluate the Patient Benefit of Transcorneal Electrostimulation (TES)

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jul 30, 2021
Registry last updated
Aug 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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