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Transcorneal Electrical Stimulation - Multicenter Safety Study

Primary Purpose

Retinitis Pigmentosa

Status

Completed

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

Transcorneal electrostimulation

About this trial

This is an interventional treatment trial for Retinitis Pigmentosa focused on measuring transcorneal electrostimulation

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

patients with retinitis pigmentosa (rod-cone dystrophy) after prescription of electrical stimulation by an ophthalmologist
adult patients who are capable of giving consent,
Visual acuity ≥ 0.02
because the electrode is to be positioned on the eye at home, the patient or his family members should have sufficient fine motor skills (assessment by the study physician)
the patient must be capable of giving consent and a medical assessment that he/she is able to participate in the whole study according to the protocol

Exclusion Criteria:

diabetic retinopathy
neovascularisation of any origin
after arterial or venous occlusion
after retinal detachment
silicone oil tamponade
dry or exudative age-related macular degeneration
macular edema
all forms of glaucoma
any form of corneal degeneration that reduces visual acuity
systemic diseases that are difficult to control or manage, that could endanger the normal study schedule
patients in a permanently poor general condition, which could hinder the regular attendance at control examinations in the clinic
forms of mental illness related to the bipolar affective and schizoid-affective disorders, and all forms of dementia
simultaneous participation in another interventional study or history of interventions whose effect may still persist

Sites / Locations

Glostrup Hospital and Kennedy Center
University Eye Clinic Bonn
Augenzentrum München
University Eye Clinic Regensburg
Zentrum für seltene Netzhauterkrankungen, AugenZentrum Siegburg
Centre for Ophthalmology at the eye clinic Tübingen
Oslo University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

OkuStim

Arm Description

Electrostimulation Standard Treatment with OkuStim

Outcomes

Primary Outcome Measures

ophthalmic examinations

visual acuity slit lamp microscopy for examination of the anterior and posterior segment intraocular pressure measurement visual field examination Optical coherence tomography (OCT) Digital colour fundus photography

Secondary Outcome Measures

Questionnaires

Questionnaires to collect the patient's perceived benefits of treatment and handling of the device

Full Information

NCT ID

NCT01835002

First Posted

April 15, 2013

Last Updated

March 2, 2021

Sponsor

Okuvision GmbH

1. Study Identification

Unique Protocol Identification Number

NCT01835002

Brief Title

Transcorneal Electrical Stimulation - Multicenter Safety Study

Official Title

Transcorneal Electrical Stimulation for the Treatment of Retinitis Pigmentosa - a Multicenter Safety Study of the Okustim ® System

Study Type

Interventional

2. Study Status

Record Verification Date

March 2021

Overall Recruitment Status

Completed

Study Start Date

September 2012 (undefined)

Primary Completion Date

July 2014 (Actual)

Study Completion Date

August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Okuvision GmbH

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to expand the safety assessment of repeated applications of an electrical current from a DTL-like electrode in patients with RP.

Detailed Description

This is a single-arm open label interventional safety trial with RP patients, who receive weekly TES for 6 months on 1 eye followed by observation for another 6 months without stimulation. The primary outcome measure is safety, indicated by the frequency and severity of adverse events.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Retinitis Pigmentosa

Keywords

transcorneal electrostimulation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

105 (Actual)

8. Arms, Groups, and Interventions

Arm Title

OkuStim

Arm Type

Experimental

Arm Description

Electrostimulation Standard Treatment with OkuStim

Intervention Type

Device

Intervention Name(s)

Transcorneal electrostimulation

Other Intervention Name(s)

OkuStim, TES, TcES

Intervention Description

Weekly stimulation for 30 minutes with current of TES delivered of 150% of the individual phosphene threshold.

Primary Outcome Measure Information:

Title

ophthalmic examinations

Description

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Questionnaires

Description

Questionnaires to collect the patient's perceived benefits of treatment and handling of the device

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: patients with retinitis pigmentosa (rod-cone dystrophy) after prescription of electrical stimulation by an ophthalmologist adult patients who are capable of giving consent, Visual acuity ≥ 0.02 because the electrode is to be positioned on the eye at home, the patient or his family members should have sufficient fine motor skills (assessment by the study physician) the patient must be capable of giving consent and a medical assessment that he/she is able to participate in the whole study according to the protocol Exclusion Criteria: diabetic retinopathy neovascularisation of any origin after arterial or venous occlusion after retinal detachment silicone oil tamponade dry or exudative age-related macular degeneration macular edema all forms of glaucoma any form of corneal degeneration that reduces visual acuity systemic diseases that are difficult to control or manage, that could endanger the normal study schedule patients in a permanently poor general condition, which could hinder the regular attendance at control examinations in the clinic forms of mental illness related to the bipolar affective and schizoid-affective disorders, and all forms of dementia simultaneous participation in another interventional study or history of interventions whose effect may still persist

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Florian Gekeler, Prof Dr med

Organizational Affiliation

Eberhard-Karls-Universität Tübingen

Official's Role

Principal Investigator

Facility Information:

Facility Name

Glostrup Hospital and Kennedy Center

City

Glostrup

Country

Denmark

Facility Name

University Eye Clinic Bonn

City

Bonn

ZIP/Postal Code

53127

Country

Germany

Facility Name

Augenzentrum München

City

Munich

Country

Germany

Facility Name

University Eye Clinic Regensburg

City

Regensburg

ZIP/Postal Code

93053

Country

Germany

Facility Name

Zentrum für seltene Netzhauterkrankungen, AugenZentrum Siegburg

City

Siegburg

ZIP/Postal Code

53721

Country

Germany

Facility Name

Centre for Ophthalmology at the eye clinic Tübingen

City

Tübingen

ZIP/Postal Code

72076

Country

Germany

Facility Name

Oslo University Hospital

City

Oslo

Country

Norway

12. IPD Sharing Statement

Citations:

PubMed Identifier

23049087

Citation

Naycheva L, Schatz A, Rock T, Willmann G, Messias A, Bartz-Schmidt KU, Zrenner E, Gekeler F. Phosphene thresholds elicited by transcorneal electrical stimulation in healthy subjects and patients with retinal diseases. Invest Ophthalmol Vis Sci. 2012 Nov 1;53(12):7440-8. doi: 10.1167/iovs.12-9612.

Results Reference

background

PubMed Identifier

22350549

Citation

Gekeler F; Arbeitsgruppe Elektrostimulation des Department fur Augenheilkunde am Universitats-Klinikum Tubingen. [Transcorneal electrostimulation]. Ophthalmologe. 2012 Feb;109(2):129-35. doi: 10.1007/s00347-011-2450-6. German.

Results Reference

background

PubMed Identifier

21467183

Citation

Schatz A, Rock T, Naycheva L, Willmann G, Wilhelm B, Peters T, Bartz-Schmidt KU, Zrenner E, Messias A, Gekeler F. Transcorneal electrical stimulation for patients with retinitis pigmentosa: a prospective, randomized, sham-controlled exploratory study. Invest Ophthalmol Vis Sci. 2011 Jun 23;52(7):4485-96. doi: 10.1167/iovs.10-6932.

Results Reference

background

PubMed Identifier

22807300

Citation

Schatz A, Arango-Gonzalez B, Fischer D, Enderle H, Bolz S, Rock T, Naycheva L, Grimm C, Messias A, Zrenner E, Bartz-Schmidt KU, Willmann G, Gekeler F. Transcorneal electrical stimulation shows neuroprotective effects in retinas of light-exposed rats. Invest Ophthalmol Vis Sci. 2012 Aug 15;53(9):5552-61. doi: 10.1167/iovs.12-10037.

Results Reference

background

PubMed Identifier

23329121

Citation

Rock T, Schatz A, Naycheva L, Gosheva M, Pach J, Wilhelm B, Peters T, Bartz-Schmidt KU, Zrenner E, Willmann G, Gekeler F. [Effects of transcorneal electrical stimulation in patients with Stargardt's disease]. Ophthalmologe. 2013 Jan;110(1):68-73. doi: 10.1007/s00347-012-2749-y. German.

Results Reference

background

PubMed Identifier

31775146

Citation

Jolly JK, Wagner SK, Martus P, MacLaren RE, Wilhelm B, Webster AR, Downes SM, Charbel Issa P, Kellner U, Jagle H, Ruther K, Bertelsen M, Bragadottir R, Prener Holtan J, van den Born LI, Sodi A, Virgili G, Gosheva M, Pach J, Zundorf I, Zrenner E, Gekeler F. Transcorneal Electrical Stimulation for the Treatment of Retinitis Pigmentosa: A Multicenter Safety Study of the OkuStim(R) System (TESOLA-Study). Ophthalmic Res. 2020;63(3):234-243. doi: 10.1159/000505001. Epub 2019 Nov 26.

Results Reference

result

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Transcorneal Electrical Stimulation - Multicenter Safety Study

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