NCT01837901

Brief 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. In this study, the patients will be stimulated with either 0%, 150% or 200% of the individually determined phosphene threshold.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
88

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

April 9, 2013

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 23, 2013

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
7.1 years until next milestone

Results Posted

Study results publicly available

March 18, 2021

Completed
Last Updated

March 18, 2021

Status Verified

February 1, 2021

Enrollment Period

2.1 years

First QC Date

April 9, 2013

Results QC Date

February 23, 2021

Last Update Submit

February 23, 2021

Conditions

Retinitis Pigmentosa

Keywords

Transcorneal electrostimulationTcESTES

Outcome Measures

Primary Outcomes (2)

  • Visual Field, III4e

    Change in the area measured by kinetic visual field measurement

    one year

  • Visual Field, V4e

    Change in the area measured by kinetic visual field measurement

    one year

Secondary Outcomes (5)

  • ERG B-wave

    one year

  • ERG A-wave

    one year

  • BCVA

    one year

  • VFQ-25

    one year

  • Dark Adaptation

    one year

Study Arms (3)

Sham

SHAM COMPARATOR

OkuStim is used to determine the phosphene threshold, device is turned on but no stimulation is performed.

Device: Transcorneal electrostimulation

150%

EXPERIMENTAL

OkuStim 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.

Device: Transcorneal electrostimulation

200%

EXPERIMENTAL

OkuStim 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.

Device: Transcorneal electrostimulation

Interventions

Transcorneal electrostimulationDEVICE
Also known as: OkuStim, TES, TcES
150%200%Sham

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department für Augenheilkunde, Eberhard-Karls-Universität

Tübingen, 72076, Germany

Location

Related Publications (6)

  • 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.

    PMID: 23049087BACKGROUND

  • 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.

    PMID: 22350549BACKGROUND

  • 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.

    PMID: 21467183BACKGROUND

  • 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.

    PMID: 22807300BACKGROUND

  • 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.

    PMID: 23329121BACKGROUND

  • 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.

    PMID: 28114587RESULT

MeSH Terms

Conditions

Retinitis Pigmentosa

Condition Hierarchy (Ancestors)

Eye Diseases, HereditaryEye DiseasesRetinal DystrophiesRetinal DegenerationRetinal DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Results Point of Contact

Title
Dr. R. Schippert
Organization
Okuvision GmbH
ruth.schippert@okuvision.de
+49 7121 15935

Study Officials

  • Florian Gekeler, Prof. Dr.

    Eberhard-Karls-Universität Tübingen

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 9, 2013

First Posted

April 23, 2013

Study Start

July 1, 2011

Primary Completion

August 1, 2013

Study Completion

February 1, 2014

Last Updated

March 18, 2021

Results First Posted

March 18, 2021

Record last verified: 2021-02

Locations

DE(1)