Retinitis PigmentosaTESOLAUKNCT01847365
TES for the Treatment of RP
A study testing Transcorneal electrical stimulation in people with Retinitis Pigmentosa, run by University of Oxford at 2 sites in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Retinitis Pigmentosa
- What is being tested?
- Transcorneal electrical stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Apr 2013to Feb 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participant is willing and able to give informed consent for participation in the study
- Male or Female, 18 or more years of age
- Diagnosis of retinitis pigmentosa (rod-cone dystrophy) made by an ophthalmologist
- Participants should have a visual acuity of ≥ 0.02 (Snellen Chart)
- Able (in the investigators opinion) and willing to comply with all study requirements
- Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the study
- Participants, or a designated other, should have sufficient motor skills (assessed by the investigator) to apply the device independently
Who cannot join
- Female participants who are pregnant, lactating or planning pregnancy during the course of the study
- Diabetic Retinopathy
- Previous arterial or venous occlusion of the retina
- Previous retinal detachment
- Previous silicone oil tamponade
- Dry or exudative age-related macular degeneration
Show all 13Show fewer
- Macular oedema
- All forms of glaucoma
- Any form of corneal degeneration that reduces visual acuity
- Neovascularisation of any origin
- Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study
- Forms of mental illness related to bipolar affective and schizoid-affective disorders, and all forms of dementia
- Simultaneous participation in another interventional study or history of interventions where effects may still persist
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Moorfields Eye Hospital NHS Foundation Trust
London, EC1V 2PD
Oxford University Hospitals NHS Trust
Oxford, Oxfordshire, OX3 9DU
About this study
Official title: Transcorneal Electrical Stimulation for the Treatment of Retinitis Pigmentosa - a Multicentre Safety Study of the Okustim® System
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.
Read more
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. 12 participants will be enrolled for 1 year across two sites in the UK - the Oxford Eye Hospital and London Moorfields Eye Hospital.
Recruited participants will undergo weekly TES of 1 eye 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.
Participants should have a diagnosis of RP and be capable of giving consent. 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.
- Conditions
- Retinitis Pigmentosa
- Being tested
- Transcorneal electrical stimulation
- Keywords
- Retinitis Pigmentosa, Transcorneal electrical stimulation, Okustim
- Medical subject headings
- Retinitis Pigmentosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcorneal electrical stimulationDevice
Transcorneal electrical stimulation will be delivered by the CE-marked Okustim device.
| Study group | Role | What they receive |
|---|---|---|
| Retinitis Pigmentosa | Experimental | Transcorneal electrical stimulation (TES) administered to one eye for 6 months, followed by monitoring period without treatment for 6 months. Receives: Device: Transcorneal electrical stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events
Quantity and Character of Adverse Events Related to the Use of the Device
Measured: 12 months
Secondary outcomes (1)
Efficacy of Intervention
Ophthalmic examination, best corrected visual acuity, visual field assessment, microperimetry, optical coherence tomography, fundus photography
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2013 (estimated)
- Study startApr 2013
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Retinitis PigmentosaStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- Oxford University Hospitals NHS Trust, Moorfields Eye Hospital NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Robert E MacLaren, FRCOphth DPhil, Study chair, University of Oxford, Oxford University Hospitals NHS Trust and Moorfields Eye Hospital NHS Foundation TrustSusan M Downes, FRCOphth MD, Principal investigator, Oxford University Hospitals NHS Trust and University of OxfordAndrew R Webster, FRCOphth MD, Principal investigator, UCL Institute of Ophthalmology and Moorfields Eye Hospital NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01847365
- Sponsor's protocol ID
- TESOLAUK13
- Acronym
- TESOLAUK
- Status last verified
- Nov 2018
- First submitted
- 1 May 2013
- Last updated
- 13 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Jolly JK, Wagner SK, Moules J, Gekeler F, Webster AR, Downes SM, MacLaren RE. A Novel Method for Quantitative Serial Autofluorescence Analysis in Retinitis Pigmentosa Using Image Characteristics. Transl Vis Sci Technol. 2016 Dec 1;5(6):10. doi: 10.1167/tvst.5.6.10. eCollection 2016 Dec.
PubMed 27933220Wagner SK, Jolly JK, Pefkianaki M, Gekeler F, Webster AR, Downes SM, Maclaren RE. Transcorneal electrical stimulation for the treatment of retinitis pigmentosa: results from the TESOLAUK trial. BMJ Open Ophthalmol. 2017 Dec 14;2(1):e000096. doi: 10.1136/bmjophth-2017-000096. eCollection 2017.
PubMed 29354722
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcorneal Electrical Stimulation for the Treatment of Retinitis Pigmentosa - a Multicentre Safety Study of the Okustim® System
- ClinicalTrials.gov ID
- NCT01847365
- Acronym / sponsor ID
- TESOLAUK / TESOLAUK13
- Conditions
- Retinitis Pigmentosa
- Keywords
- Retinitis Pigmentosa, Transcorneal electrical stimulation, Okustim
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- Oxford University Hospitals NHS Trust, Moorfields Eye Hospital NHS Foundation Trust
- Study start
- Apr 2013
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 6 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. 12 participants will be enrolled for 1 year across two sites in the UK - the Oxford Eye Hospital and London Moorfields Eye Hospital.
Recruited participants will undergo weekly TES of 1 eye 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.
Participants should have a diagnosis of RP and be capable of giving consent. 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Retinitis Pigmentosa | Experimental | Device: Transcorneal electrical stimulationTranscorneal electrical stimulation (TES) administered to one eye for 6 months, followed by monitoring period without treatment for 6 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Participant is willing and able to give informed consent for participation in the study
- Male or Female, 18 or more years of age
- Diagnosis of retinitis pigmentosa (rod-cone dystrophy) made by an ophthalmologist
- Participants should have a visual acuity of ≥ 0.02 (Snellen Chart)
- Able (in the investigators opinion) and willing to comply with all study requirements
Key exclusion criteria (13 listed)
- Female participants who are pregnant, lactating or planning pregnancy during the course of the study
- Diabetic Retinopathy
- Previous arterial or venous occlusion of the retina
- Previous retinal detachment
- Previous silicone oil tamponade
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcorneal electrical stimulationTranscorneal electrical stimulation will be delivered by the CE-marked Okustim device. | Device | Retinitis Pigmentosa |
Primary outcome
Adverse Events
Time frame: 12 months
Quantity and Character of Adverse Events Related to the Use of the Device
1 secondary outcome
Efficacy of Intervention
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2018.
- Background: PubMed 27933220Jolly JK, Wagner SK, Moules J, Gekeler F, Webster AR, Downes SM, MacLaren RE. A Novel Method for Quantitative Serial Autofluorescence Analysis in Retinitis Pigmentosa Using Image Characteristics. Transl Vis Sci Technol. 2016 Dec 1;5(6):10. doi: 10.1167/tvst.5.6.10. eCollection 2016 Dec.
- Results publication: PubMed 29354722Wagner SK, Jolly JK, Pefkianaki M, Gekeler F, Webster AR, Downes SM, Maclaren RE. Transcorneal electrical stimulation for the treatment of retinitis pigmentosa: results from the TESOLAUK trial. BMJ Open Ophthalmol. 2017 Dec 14;2(1):e000096. doi: 10.1136/bmjophth-2017-000096. eCollection 2017.
- Oxford Eye HospitalLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert E MacLaren, FRCOphth DPhil study chair
University of Oxford, Oxford University Hospitals NHS Trust and Moorfields Eye Hospital NHS Foundation Trust
Susan M Downes, FRCOphth MD principal investigator
Oxford University Hospitals NHS Trust and University of Oxford
Andrew R Webster, FRCOphth MD principal investigator
UCL Institute of Ophthalmology and Moorfields Eye Hospital NHS Foundation Trust
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcorneal electrical stimulation in people with Retinitis Pigmentosa, run by University of Oxford at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01847365, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2018; AzTrials last refreshed its copy on 7 Nov 2026.