N/A
N=63
Transcorneal Electrostimulation for Therapy of Retinitis Pigmentosa
Retinitis Pigmentosa
Bottom Line
View on ClinicalTrials.gov: NCT01837901 ↗Enrolled (actual)
63
Serious AEs
0.0%
Results posted
Mar 2021
Primary outcome: Primary: Visual Field, III4e — 4835.29; 4988.43; 6234.59; 4488.39 deg2
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Transcorneal electrostimulation (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Okuvision GmbH
- Primary completion
- Aug 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Visual Field, III4e |
4835.29; 4988.43; 6234.59; 4488.39; 4962.76; 5878.75 | — |
| PRIMARY Visual Field, V4e |
7135.77; 7599.65; 8303.59; 6730.20; 7641.55; 8112.18 | — |
| SECONDARY ERG B-wave |
— | — |
| SECONDARY ERG A-wave |
— | — |
| SECONDARY BCVA |
— | — |
| SECONDARY VFQ-25 |
— | — |
| SECONDARY Dark Adaptation |
— | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT01837901). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.