Transcorneal Electrical Stimulation for the Treatment of Retinitis Pigmentosa - a Safety and Efficacy Multicenter Study
NCT ID: NCT02548572
Last Updated: 2019-05-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2019-01-31
2020-12-31
Brief Summary
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Detailed Description
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Study Design - Multi-center, prospective, randomized sham controlled 1:1 Clinical trial.
Study treatments - Patients will be randomized in a 1:1 ratio. Patients in treatment group will have TES at 200% of phosphene threshold for 30 minutes once weekly for 52 weeks in both eyes. Patients in sham group will also wear electrodes on both eyes, but no energy is turned on and both eyes are sham.
Duration of study - anticipated duration is 36 months, 12 months for recruitment, 12 months for treatment and sham groups and followed for 18 months, plus 6 months for analysis.
Inclusion Criteria - Diagnosis of RP, 22-80 years of age, no other ocular disease, able to complete all visits.
Treatments - TES, 30 minute treatment weekly for 52 weeks at 0.8mA
Number of patients - 90 patients in treatment arm and 90 patients in sham arm. Electrodes will be placed on both eyes, both eyes will be treated in treatment group and in the sham group both eyes will be considered. However due to the possibility of drop out using 15% we will recruit 210 patients (15 patients per center).
Screening -
1. VA \& Phosphene threshold evaluation
2. Vfiii4e, vfVe, Octopus 900, complete eye exam, fundus photo, OCT and Contrast sensitivity, electro-physiology.
3. Eligibility requirements met, then schedule baseline.
Tests - Base Line: VA, vfiii4e, vfVe, Octopus 900, complete eye exam, fundus photo, OCT, Contrast sensitivity, NEI VFQ-25, Photopic B-wave ERG, blood draw for genetic test (unless genetic profile has been done).
3 Month visit: VA, eye exam, Phosphene threshold, OCT \& Photopic B-wave.
6 Month visit: VA, vfiii4e, vfVe, Octopus 900, complete eye exam, OCT \& Contrast sensitivity, phosphine threshold \& Photopic B-wave.
9 Month visit: VA, eye exam, Phosphene threshold, OCT \& Photopic B-wave.
12 Month visit: VA, vfiii4e, vfVe, Octopus 900, complete eye exam, OCT \& Contrast sensitivity, NEI VFQ-25, phosphene threshold \& Photopic B-wave
18 Month visit: VA, vfiii4e, vfVe, Octopus 900, complete eye exam, OCT \& Contrast sensitivity, NEI VFQ-25 \& phosphene threshold \& Photopic B-wave.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Treatment group
Subjects in the treatment group will undergo bilateral transcorneal electrical stimulation using OkuStim device once a week for fifty-two weeks
Transcorneal Electrical Stimulation using Okustim device
The Okustim® stimulation device is a battery-powered electronic neuro-stimulator, which delivers a weak electrical pulse. This current is delivered to the eyes by the OkuStim® device using the "OkuEl®" electrodes, which are held in place via the "OkuSpex®" frame. In this study the treatment level will be held constant at 0.8 mA for all study subjects. After switching on the neuro-stimulator, the subject's retina will be stimulated through specific electrodes (OkuEl, held in position by the OkuSpex) worn on the face with the predetermined intensity and time period (delivered by the OkuStim device).
Sham group
Subjects in the Sham group will wear the OkuSpex and OkuEl (applied to cornea upon the lower lid) and be attached to the OkuStim device in the same manner as the treatment group, but will receive no electrical stimulation for the 30 minutes that the TES fiber is applied to the cornea (even though the device has been turned on) once a week for fifty-two weeks
Transcorneal Electrical Stimulation using Okustim device
The Okustim® stimulation device is a battery-powered electronic neuro-stimulator, which delivers a weak electrical pulse. This current is delivered to the eyes by the OkuStim® device using the "OkuEl®" electrodes, which are held in place via the "OkuSpex®" frame. In this study the treatment level will be held constant at 0.8 mA for all study subjects. After switching on the neuro-stimulator, the subject's retina will be stimulated through specific electrodes (OkuEl, held in position by the OkuSpex) worn on the face with the predetermined intensity and time period (delivered by the OkuStim device).
Interventions
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Transcorneal Electrical Stimulation using Okustim device
The Okustim® stimulation device is a battery-powered electronic neuro-stimulator, which delivers a weak electrical pulse. This current is delivered to the eyes by the OkuStim® device using the "OkuEl®" electrodes, which are held in place via the "OkuSpex®" frame. In this study the treatment level will be held constant at 0.8 mA for all study subjects. After switching on the neuro-stimulator, the subject's retina will be stimulated through specific electrodes (OkuEl, held in position by the OkuSpex) worn on the face with the predetermined intensity and time period (delivered by the OkuStim device).
Eligibility Criteria
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Inclusion Criteria
2. Adult patients, 22-80 years of age, having provided written informed consent and HIPAA authorization.
3. LogMAR VA 1.00 or better in both eyes.
4. Octopus 900 Central Visual Field ≥10 degrees diameter around central fixation using stimulus sizes III4e and V4e in both eyes on kinetic testing.
5. Agree to discontinue Vitamin A use and no intake for at least 2 months prior to baseline visit.
Exclusion Criteria
2. Due to distance or other reason, patients unable to travel to Philadelphia or respective centers for the treatment procedures and follow-up examinations.
3. Diabetic retinopathy
4. Ocular neovascularisation of any origin
5. After arterial or venous occlusion
6. After retinal detachment or any vitreoretinal surgery with or without implantation.
7. Silicone oil tamponade
8. Dry or exudative age-related macular degeneration
9. Macular edema involving the foveal center as determined by SD-OCT
10. All forms of glaucoma
11. Any form of corneal degeneration that reduces visual acuity
12. Systemic diseases that are difficult to control or manage, which could hinder regular attendance at follow-up examinations
13. Patients in a permanently poor general condition, which could hinder regular attendance at follow-up examinations
14. Patients in whom phosphenes are only inducible at greater than, but not including, 0.8 mA.
15. Forms of mental illness related to the bipolar affective and schizoid-affective disorders, epilepsy, and all forms of dementia
16. Simultaneous participation in another interventional study or history of interventions whose effect may still persist
17. Current pregnancy, or being a woman with childbearing potential who is unwilling to use medically acceptable means of birth control for the study duration, or a woman unwilling to perform a pregnancy test at study entry
18. Any patient can be excluded from the study as determined by the Principal Investigator.
22 Years
80 Years
ALL
No
Sponsors
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Okuvision GmbH
INDUSTRY
Wills Eye
OTHER
Responsible Party
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Principal Investigators
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Leslie Hyman, PhD
Role: STUDY_DIRECTOR
Wills Eye Hospital
Locations
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Wills Eye Health System
Philadelphia, Pennsylvania, United States
Countries
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Other Identifiers
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IMC1TES/RP
Identifier Type: -
Identifier Source: org_study_id
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