Condition category
Eye Diseases
Date applied
17/05/2013
Date assigned
17/05/2013
Last edited
23/01/2018
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Dr Siegfried Wagner

ORCID ID

Contact details

John Radcliffe Hospital
Dept of Clinical Neurology
Level 6
West Wing
Headley Way
Headington
Oxford
OX3 9DU
United Kingdom
-
siegfried.wagner@ndcn.ox.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

14217

Study information

Scientific title

Transcorneal electrical stimulation for the treatment of retinitis pigmentosa: a multicentre safety study of the Okustim® system

Acronym

TESOLAUK

Study hypothesis

Retinitis 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

South West Research Ethics Committee, First MREC approval date 27/11/2012, ref: 12/SW/0293

Study design

Non-randomised interventional treatment trial

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Retinitis pigmentosa

Intervention

Recruited 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 type

Device

Phase

Drug names

Primary outcome measure

Adverse events measured at 3, 6, 9 and 12 months after commencing the trial

Secondary outcome measures

1. 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 trial start date

01/04/2013

Overall trial end date

01/04/2015

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. 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.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

UK Sample Size: 12

Participant exclusion criteria

1. 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

Recruitment start date

01/06/2013

Recruitment end date

01/06/2014

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Oxford Eye Hospital
Oxford
OX3 9DU
United Kingdom

Trial participating centre

London Moorfields Eye Hospital
London
EC1V 2PD
United Kingdom

Sponsor information

Organisation

University of Oxford (UK)

Sponsor details

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

Sponsor type

University/education

Website

http://www.ox.ac.uk/

Funders

Funder type

Industry

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Okuvision GmbH (Germany)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Interim 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 statement
The datasets generated and/or analysed during the current study will be included in the subsequent results publication.

Intention to publish date

23/07/2018

Participant level data

Other

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

07/12/2017: Publication and dissemination plan and IPD sharing statement added.