Transcorneal Electrostimulation for Therapy of Retinitis Pigmentosa

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2014-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Study to Evaluate Ultevursen in Subjects With Retinitis Pigmentosa (RP) Due to Mutations in Exon 13 of the USH2A Gene

NCT06627179

Retinitis Pigmentosa (RP) Usher Syndrome Type 2 Deaf Blind +4 more

RECRUITING PHASE2

A Prospective, Observational Study in Adults With Retinitis Pigmentosa (RP)

NCT06517940

Retinitis Pigmentosa

ACTIVE_NOT_RECRUITING

Clinical and Genetic Findings in Patients With PRPF31-associated Retinitis Pigmentosa

NCT06368375

Retinitis Pigmentosa

COMPLETED

Reading Analysis in Ophthalmologic Patients

NCT03750149

Diabetic Maculopathy Age Related Macular Degeneration Glaucoma +1 more

UNKNOWN NA

Subthreshold Micropulse Laser Therapy (SML) in Retinitis Pigmentosa

NCT07088705

Retinitis Pigmentosa (RP)

ENROLLING_BY_INVITATION NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Retinitis Pigmentosa

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Sham

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

Group Type SHAM_COMPARATOR

Transcorneal electrostimulation

Intervention Type DEVICE

150%

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.

Group Type EXPERIMENTAL

Transcorneal electrostimulation

Intervention Type DEVICE

200%

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.

Group Type EXPERIMENTAL

Transcorneal electrostimulation

Intervention Type DEVICE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Transcorneal electrostimulation

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

OkuStim TES TcES

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No