Retinitis Pigmentosa Clinical Trial
Official title:
Transkorneale Elektrostimulation Zur Therapie Bei Retinitis Pigmentosa - Eine Prospektive, Randomisierte, Einfach Blinde Folgestudie
NCT number | NCT01837901 |
Other study ID # | EST2 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | July 2011 |
Est. completion date | February 2014 |
Verified date | February 2021 |
Source | Okuvision GmbH |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 88 |
Est. completion date | February 2014 |
Est. primary completion date | August 2013 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Germany | Department für Augenheilkunde, Eberhard-Karls-Universität | Tübingen |
Lead Sponsor | Collaborator |
---|---|
Okuvision GmbH |
Germany,
Gekeler F; Arbeitsgruppe Elektrostimulation des Department für Augenheilkunde am Universitäts-Klinikum Tübingen. [Transcorneal electrostimulation]. Ophthalmologe. 2012 Feb;109(2):129-35. doi: 10.1007/s00347-011-2450-6. German. — View Citation
Naycheva L, Schatz A, Röck 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. — View Citation
Röck 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. — View Citation
Schatz A, Arango-Gonzalez B, Fischer D, Enderle H, Bolz S, Röck 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. — View 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 S — View Citation
Schatz A, Röck 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Visual Field, III4e | Change in the area measured by kinetic visual field measurement | one year | |
Primary | Visual Field, V4e | Change in the area measured by kinetic visual field measurement | one year | |
Secondary | ERG B-wave | one year | ||
Secondary | ERG A-wave | one year | ||
Secondary | BCVA | Best corrected visual acuity | one year | |
Secondary | VFQ-25 | Visual Function Questionnaire (VFQ-25) | one year | |
Secondary | 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). | one year |
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