Retrospective NIS to Evaluate the Patient Benefit of TES

Sponsor

Okuvision GmbH (Industry)

Overall Status

Completed

CT.gov ID

NCT04983914

Collaborator

CONET GmbH - Clinical Operations Network (Other)

Enrollment

Locations

11.4

Actual Duration (Months)

12.3

Patients Per Site

1.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Retinitis Pigmentosa	Device: Transcorneal Electrostimulation via OkuStim System

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.

Study Design

Study Type:

Observational

Actual Enrollment :

49 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Sep 6, 2021

Actual Primary Completion Date :

Aug 19, 2022

Actual Study Completion Date :

Aug 19, 2022

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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 Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

Not willing and able to consent

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Universitätsklinikum Heidelberg, Augenklinik	Heidelberg	Germany	69120
2	Klinikum Stuttgart gKAöR, Augenklinik Standort Mitte (Katharinenhospital)	Stuttgart	Germany	70174
3	Universitäts-Augenklinik Tübingen, Abt. für Augenheilkunde	Tübingen	Germany	72076
4	Universitätsspital Basel, Augenklinik	Basel	Switzerland	4031

Sponsors and Collaborators

Okuvision GmbH
CONET GmbH - Clinical Operations Network

Investigators

Principal Investigator: Hendrik Scholl, Prof. Dr., Department of Ophthalmology, University of Basel, Switzerland
Principal Investigator: Katarina Stingl, Prof. Dr., University Eye Hospital Tuebingen, Tuebingen, Germany