An interventional study of Transcorneal electrostimulation in Retinitis Pigmentosa, sponsored by Okuvision GmbH. Completed at 1 site in Germany. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-03-18.
Sponsored by Okuvision GmbH · Not applicable, Interventional, and Treatment
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.
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.
250 studies on the registry are indexed under Retinitis; 28 are open to participants now.
This study's enrollment of 88 is above the median of 31 across 158 interventional studies indexed under Retinitis.
Browse Retinitis studies →Okuvision GmbH is the lead sponsor of 7 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
OkuStim is used to determine the phosphene threshold, device is turned on but no stimulation is performed.
Device: Transcorneal electrostimulation
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
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
Also known as: OkuStim, TES, TcES
Visual Field, III4e
Change in the area measured by kinetic visual field measurement
Time frame: one year
Visual Field, V4e
Change in the area measured by kinetic visual field measurement
Time frame: one year
ERG B-wave
Time frame: one year
ERG A-wave
Time frame: one year
BCVA
Best corrected visual acuity
Time frame: one year
VFQ-25
Visual Function Questionnaire (VFQ-25)
Time frame: one year
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).
Time frame: one year
Patients were recruited from the hospital's hereditary retinal degeneration clinic (Centre for Ophthalmology, University of Tuebingen, Tuebingen, Germany). Of 88 enrolled participants, 63 met the inclusion criteria and were randomized to treatment.
| Milestone | Sham | 150% | 200% |
|---|---|---|---|
| Started | 22 | 21 | 20 |
| Completed | 20 | 15 | 17 |
| Not completed | 2 | 6 | 3 |
Change in the area measured by kinetic visual field measurement
| deg2 | Sham | 150% | 200% |
|---|---|---|---|
| Baseline | 4835.29 (2723.26 to 6947.32) | 4988.43 (2799.14 to 7177.73) | 6234.59 (4226.84 to 8242.34) |
| 1 year | 4488.39 (2473.83 to 6502.95) | 4962.76 (2765.44 to 7160.08) | 5878.75 (3926.21 to 7831.28) |
Change in the area measured by kinetic visual field measurement
| deg2 | Sham | 150% | 200% |
|---|---|---|---|
| Baseline | 7135.77 (4771.87 to 9499.66) | 7599.65 (5004.80 to 10194.50) | 8303.59 (6217.92 to 10389.27) |
| 1 year | 6730.20 (4459.71 to 9000.69) | 7641.55 (4945.26 to 10337.84) | 8112.18 (6028.01 to 10196.34) |
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Best corrected visual acuity
Results for this outcome have not been posted.
Visual Function Questionnaire (VFQ-25)
Results for this outcome have not been posted.
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).
Results for this outcome have not been posted.
Collected over 52 weeks treatment, follow-up visit after 72 weeks. AEs were recorded until the follow-up visit at 72 weeks.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Sham | 0/22 (0%) | 0/22 (0%) | 13/22 (59.1%) |
| 150% | 0/21 (0%) | 0/21 (0%) | 18/21 (85.7%) |
| 200% | 0/20 (0%) | 0/20 (0%) | 20/20 (100%) |
| Event | Sham | 150% | 200% |
|---|---|---|---|
| Dry Eye SymptomEye disorders | 2/22 | 14/21 | 14/20 |
| Non-Ocular Adverse Events TotalGeneral disorders | 10/22 | 11/21 | 11/20 |
| Ocular discomfortEye disorders | 2/22 | 2/21 | 1/20 |
| Ocular painEye disorders | 2/22 | 2/21 | 0/20 |
| Corneal erosionEye disorders | 0/22 | 0/21 | 1/20 |
| General and ocular infectionEye disorders | 0/22 | 0/21 | 1/20 |
| Skin irritation due to electrodeEye disorders | 0/22 | 1/21 | 0/20 |
| Ocular infectionEye disorders | 0/22 | 1/21 | 0/20 |
| Macular edemaEye disorders | 1/22 | 0/21 | 0/20 |
| Subjective visual decreaseEye disorders | 1/22 | 0/21 | 0/20 |
| Age, Continuous(years) | Sham | 150% | 200% | Total |
|---|---|---|---|---|
| Mean | 48 ± 15 | 42 ± 13 | 49 ± 16 | 46 ± 15 |
| Sex: Female, Male(Participants) | Sham | 150% | 200% | Total |
|---|---|---|---|---|
| Female | 11 | 7 | 7 | 25 |
| Male | 9 | 8 | 10 | 27 |
| Region of Enrollment(participants) | Sham | 150% | 200% | Total |
|---|---|---|---|---|
| Germany | 20 | 15 | 17 | 52 |
This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.
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