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Retinitis PigmentosaNCT01837901

Transcorneal Electrostimulation for Therapy of Retinitis Pigmentosa

A study testing Transcorneal electrostimulation in people with Retinitis Pigmentosa, run by Okuvision GmbH at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to determine the long-term effects of transcorneal electrostimulation (TcES) in patients with retinitis pigmentosa (RP). In a prior study (NCT00804102) the results of short-term stimulation showed a positive effect on the visual field and other parameters. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Retinitis Pigmentosa
What is being tested?
Transcorneal electrostimulation
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
88 participants
Where
1 siteGermany
Study dates
Jul 2011to Feb 2014
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adult subject with RP (rod-cone dystrophy)
  • BCVA 0.02 to 0.9
  • Reliable visual field measurements
  • Reliable ERG measurements
  • Skillful enough to use the device at home
  • Able to give consent and take part during the whole study

Who cannot join

  • Diabetic retinopathy
  • Neovascularisation of any origin
  • After arterial or venous occlusion
  • After retinal detachment
  • Silicone oil tamponade
  • Dry or exudative age-related macular degeneration
Show all 13Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Department für Augenheilkunde, Eberhard-Karls-Universität

    Tübingen, 72076

Other trials in Germany

About this study

Official title: Transkorneale Elektrostimulation Zur Therapie Bei Retinitis Pigmentosa - Eine Prospektive, Randomisierte, Einfach Blinde Folgestudie

The purpose of this study is to determine the long-term effects of transcorneal electrostimulation (TcES) in patients with retinitis pigmentosa (RP). In a prior study (NCT00804102) the results of short-term stimulation showed a positive effect on the visual field and other parameters. In this study, the patients will be stimulated with either 0%, 150% or 200% of the individually determined phosphene threshold.

Read the detailed description

The study was performed at the Centre for Ophthalmology, University of Tübingen, Germany. The protocol was approved by the local ethics committee. All procedures followed were in accordance with the ethical standards of the responsible committee on human experimentation (institutional and national) and with the Helsinki Declaration of 1975, as revised in 2008. Informed consent was obtained from all patients for being included in the study. The study was conducted according to the standards of GCP, the European Union Directive for Medical Devices, and the German Medical Product Law.

Patients were seen at 14 visits over a period of 78 weeks: one baseline visit (screening), followed by 12 visits (in week 1-4 weekly, then in weeks 10, 16, 22, 28, 34, 40, 46 and 52; dates varied a maximum of ± 1 week) including application of TcES for 52 weeks and one follow-up visit (in week 78, dates varied a maximum of ± 1 week).

After inclusion patients were randomly assigned to TcES with 0 mA (sham), 150% or 200% of their individual electrical phosphene threshold (EPT) current at 20 Hz.

Patients and technicians who performed kinetic perimetry, as well as full-field electrophysiology (ERG), multifocal ERG (mfERG) and dark adaptation, were blinded to the treatment group for the entire study period. The physicians who performed all other examinations and TcES were not blinded to study treatment because they were responsible for setting the stimulation parameters.

Being tested
Transcorneal electrostimulation
Keywords
Transcorneal electrostimulation, TcES, TES
Medical subject headings
Retinitis Pigmentosa

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Transcorneal electrostimulationDevice

    Also called OkuStim, TES, TcES

Study groups in NCT01837901
Study groupRoleWhat they receive
ShamSham comparatorOkuStim is used to determine the phosphene threshold, device is turned on but no stimulation is performed.
Receives: Device: Transcorneal electrostimulation
150%ExperimentalOkuStim is used to determine the phosphene threshold, and then to administer transcorneal electrostimulation with a stimulation strength corresponding to 150% of the patient's phosphene threshold.
Receives: Device: Transcorneal electrostimulation
200%ExperimentalOkuStim is used to determine the phosphene threshold, and then to administer transcorneal electrostimulation with a stimulation strength corresponding to 200% of the patient's phosphene threshold.
Receives: Device: Transcorneal electrostimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Visual Field, III4e

    Change in the area measured by kinetic visual field measurement

    Measured: one year

  2. Visual Field, V4e

    Change in the area measured by kinetic visual field measurement

    Measured: one year

Secondary outcomes (5)

  1. ERG B-wave

    Measured: one year

  2. ERG A-wave

    Measured: one year

  3. BCVA

    Best corrected visual acuity

    Measured: one year

  4. VFQ-25

    Visual Function Questionnaire (VFQ-25)

    Measured: one year

  5. Dark Adaptation

    Adaptation time, changes in pupil diameter, threshold to fullfield blue and red light is measured with a fullfield stimulus threshold test (FST) on the ESPION ERG machine (Diagnosys).

    Measured: one year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Apr 2013 (estimated)
  2. Study startJul 2011
  3. Primary completionAug 2013
  4. Study completionFeb 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
88 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01837901
Sponsor's protocol ID
EST2
Status last verified
Feb 2021
First submitted
9 Apr 2013
Last updated
18 Mar 2021
Data monitoring committee
No

Publications

  • 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.

    PubMed 23049087

  • 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.

    PubMed 22350549

  • 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.

    PubMed 21467183

  • 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.

    PubMed 22807300

  • 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.

    PubMed 23329121

  • Schatz A, Pach J, Gosheva M, 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 Follow-up Study Over 1 Year. Invest Ophthalmol Vis Sci. 2017 Jan 1;58(1):257-269. doi: 10.1167/iovs.16-19906.

    PubMed 28114587

Questions about this trial

What is this clinical trial studying?

A study testing Transcorneal electrostimulation in people with Retinitis Pigmentosa, run by Okuvision GmbH at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Mar 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Visual Field, III4e (time frame: one year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01837901, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2021.

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