Transcorneal Electrostimulation for Therapy of Retinitis Pigmentosa
Primary Purpose
Retinitis Pigmentosa
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Transcorneal electrostimulation
Sponsored by
About this trial
This is an interventional treatment trial for Retinitis Pigmentosa focused on measuring Transcorneal electrostimulation, TcES, TES
Eligibility Criteria
Inclusion Criteria:
- 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
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
- Department für Augenheilkunde, Eberhard-Karls-Universität
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Sham Comparator
Experimental
Experimental
Arm Label
Sham
150%
200%
Arm Description
OkuStim is used to determine the phosphene threshold, device is turned on but no stimulation is performed.
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.
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.
Outcomes
Primary Outcome Measures
Visual Field, III4e
Change in the area measured by kinetic visual field measurement
Visual Field, V4e
Change in the area measured by kinetic visual field measurement
Secondary Outcome Measures
ERG B-wave
ERG A-wave
BCVA
Best corrected visual acuity
VFQ-25
Visual Function Questionnaire (VFQ-25)
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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01837901
Brief Title
Transcorneal Electrostimulation for Therapy of Retinitis Pigmentosa
Official Title
Transkorneale Elektrostimulation Zur Therapie Bei Retinitis Pigmentosa - Eine Prospektive, Randomisierte, Einfach Blinde Folgestudie
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
February 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Okuvision GmbH
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retinitis Pigmentosa
Keywords
Transcorneal electrostimulation, TcES, TES
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
88 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sham
Arm Type
Sham Comparator
Arm Description
OkuStim is used to determine the phosphene threshold, device is turned on but no stimulation is performed.
Arm Title
150%
Arm Type
Experimental
Arm Description
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.
Arm Title
200%
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Transcorneal electrostimulation
Other Intervention Name(s)
OkuStim, TES, TcES
Primary Outcome Measure Information:
Title
Visual Field, III4e
Description
Change in the area measured by kinetic visual field measurement
Time Frame
one year
Title
Visual Field, V4e
Description
Change in the area measured by kinetic visual field measurement
Time Frame
one year
Secondary Outcome Measure Information:
Title
ERG B-wave
Time Frame
one year
Title
ERG A-wave
Time Frame
one year
Title
BCVA
Description
Best corrected visual acuity
Time Frame
one year
Title
VFQ-25
Description
Visual Function Questionnaire (VFQ-25)
Time Frame
one year
Title
Dark Adaptation
Description
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).
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
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.
Organizational Affiliation
Eberhard-Karls-Universität Tübingen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department für Augenheilkunde, Eberhard-Karls-Universität
City
Tübingen
ZIP/Postal Code
72076
Country
Germany
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
28114587
Citation
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.
Results Reference
result
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Transcorneal Electrostimulation for Therapy of Retinitis Pigmentosa
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