Transcorneal electrical stimulation for the treatment of retinitis pigmentosa

ISRCTN ISRCTN83743213
DOI https://doi.org/10.1186/ISRCTN83743213
ClinicalTrials.gov number NCT01847365
Secondary identifying numbers 14217
Submission date
17/05/2013
Registration date
17/05/2013
Last edited
21/08/2019
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Eye Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Background and study aims
Retinitis pigmentosa (RP) is a progressive degenerative eye disease that affects the retina, which often leads to blindness. 1 in 4000 people in the UK is affected by RP yet there is no established therapy for treating or delaying its progression.Transcorneal electrical stimulation (TES) has gained attention as a possible treatment option for RP. Research has shown that TES improves retinal cell viability and visual function. An initial small study of TES on 24 participants with RP demonstrated that it was safe and improved vision. This study aims to confirm the safety of the new CE-approved Okustim device and to further study the benefits of TES on a larger scale.

Who can participate?
Patients aged 18 and over with retinitis pigmentosa (diagnosed by an ophthalmologist). Participants, or a carer, should have sufficient motor skills to attach the device themselves. As this study seeks to ascertain the impact of TES on RP, participants with other eye diseases (e.g. diabetic retinopathy) cannot be included in the study.

What does the study involve?
All 12 recruited participants undergo weekly TES of one eye for 30 minutes for a period of 6 months. This is followed by a further 6 months of observation without stimulation giving a total participation time of 1 year. Participants are assessed at 3, 6, 9 and 12 months after their first visit with clinical examinations, investigations and questionnaires.

What are the possible benefits and risks of participating?
TES has been shown to improve the visual fields. TES may improve the sharpness of vision. TES will be delivered by the CE-marked Okustim device. Previous studies have demonstrated TES to be a low risk treatment. Some patients may experience irritation of the eye or a dry eye, which can be treated with artificial tears. Some participants have reported a 'prickly' sensation when the stimulation is applied.

When is the study starting and how long is it expected to run for?
April 2013 to April 2015

Where is the study run from?
1. The Oxford Eye Hospital (UK)
2. London Moorfields Eye Hospital (UK)

Who is funding the study?
Biomedical Research Centre Oxford and Okuvision GmbH

Who is the main contact?
Prof. Robert Maclaren
enquiries@eye.ox.ac.uk

Contact information

Dr Siegfried Wagner
Scientific

John Radcliffe Hospital
Dept of Clinical Neurology
Level 6
West Wing
Headley Way
Headington
Oxford
OX3 9DU
United Kingdom

Email siegfried.wagner@ndcn.ox.ac.uk

Study information

Study designNon-randomised interventional treatment trial
Primary study designInterventional
Secondary study designNon randomised study
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details to request a patient information sheet
Scientific titleTranscorneal electrical stimulation for the treatment of retinitis pigmentosa: a multicentre safety study of the Okustim® system
Study acronymTESOLAUK
Study objectivesRetinitis pigmentosa (RP) is a progressive degenerative disease of the retina, which often leads to blindness. 1 in 4000 people in the UK are affected by RP yet there is no established therapy for treating or delaying its progression. Transcorneal electrical stimulation (TES) has garnered attention as a possible therapeutic option for RP. Research has shown that TES improves retinal cell viability and visual function. An initial pilot study of TES on 24 participants with RP demonstrated that it was safe and improved vision.

This study aims to confirm the safety of the new CE-approved Okustim® device and to further characterise the benefits of TES on a larger scale.
Ethics approval(s)South West Research Ethics Committee, First MREC approval date 27/11/2012, ref: 12/SW/0293
Health condition(s) or problem(s) studiedRetinitis pigmentosa
InterventionRecruited participants will undergo weekly TES of 1 eye delivered by the CE-marked Okustim® device for 30 minutes for a period of 6 months. This will be followed by a further 6 months of observation without stimulation giving a total participation time of 1 year. Participants will be assessed at 3, 6, 9 and 12 months after their initial baseline visit by clinical examination, investigations and questionnaires.
Intervention typeDevice
Pharmaceutical study type(s)
Phase
Drug / device / biological / vaccine name(s)
Primary outcome measureAdverse events measured at 3, 6, 9 and 12 months after commencing the trial
Secondary outcome measures1. Application of Device; Timepoints: Two questionnaires detailing the participant's experience and opinion of the usability of the device
2. Efficacy of Intervention; Timepoints: Best corrected visual acuity, visual field assessment, microperimetry, fundus photography, and Optical coherence tomography (OCT)
Overall study start date01/04/2013
Completion date01/04/2015

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participantsUK Sample Size: 12
Total final enrolment14
Key inclusion criteria1. Male or female participants of 18 years of age or more
2. Participants with retinitis pigmentosa (diagnosed by an ophthalmologist)
3. Adult participants who have capacity
4. Visual acuity greater or equal to 0.02
5. Participants, their caregiver or a family member should have adequate motor skills to apply electrodes
6. Participants must be able to give consent and undertake a medical evaluation to assess whether they can participate in the whole study according to the protocol
7. Participant willing to allow their GP and consultant, if appropriate, to be notified of participation in the study.
Key exclusion criteria1. Diabetic retinopathy
2. Neovascularisation of any origin
3. Previous arterial or venous occlusion
4. Previous retinal detachment
5. Silicone oil tamponade
6. Dry or exudative age-related macular degeneration
7. Macular oedema
8. Any form of glaucoma
9. Any form of corneal disease, which impairs visual acuity
10. Systemic disease, which may be difficult to control or manage, and may affect normal study schedule
11. Mental Illness related to bipolar affective disorders, schizoid-affective disorders and all forms of dementia
12. Simultaneous participation in another interventional study or previous interventions, where effects may still persist
13. Female participants who are pregnant, lactating or planning pregnancy during the course of the study
Date of first enrolment01/06/2013
Date of final enrolment01/06/2014

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centres

Oxford Eye Hospital
Oxford
OX3 9DU
United Kingdom
London Moorfields Eye Hospital
London
EC1V 2PD
United Kingdom

Sponsor information

University of Oxford (UK)
University/education

Research Services
Clinical Trials and Research Governance
Headley Way
Headington
Oxford
OX3 9DU
England
United Kingdom

Website http://www.ox.ac.uk/
ROR logo "ROR" https://ror.org/052gg0110

Funders

Funder type

Industry

BioMedical Research Centre, Oxford (UK) Grant Codes: RWAC0

No information available

Okuvision GmbH (Germany)

No information available

Results and Publications

Intention to publish date23/07/2018
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryOther
Publication and dissemination planInterim study results were presented at the Annual Association of Research and Vision in Ophthalmology Meeting 2014 in Orlando, USA. The final study results were presented at the Annual Association of Research and Vision in Ophthalmology Meeting 2016 in Seattle, USA. A publication is currently in the processing stage.
IPD sharing planThe datasets generated and/or analysed during the current study will be included in the subsequent results publication.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 14/12/2017 21/08/2019 Yes No

Editorial Notes

21/08/2019: ClinicalTrials.gov number, publication reference and total final enrolment number added.
07/12/2017: Publication and dissemination plan and IPD sharing statement added.