Transcorneal Electrical Stimulation for the Treatment of Retinitis Pigmentosa - a Safety and Efficacy Multicenter Study (TES/RP)
Retinitis Pigmentosa
About this trial
This is an interventional treatment trial for Retinitis Pigmentosa focused on measuring Transcorneal Electrical Stimulation, TES, Retinitis Pigmentosa, RP
Eligibility Criteria
Inclusion Criteria:
- Patients with Retinitis Pigmentosa.
- Adult patients, 22-80 years of age, having provided written informed consent and HIPAA authorization.
- LogMAR VA 1.00 or better in both eyes.
- Octopus 900 Central Visual Field ≥10 degrees diameter around central fixation using stimulus sizes III4e and V4e in both eyes on kinetic testing.
- Agree to discontinue Vitamin A use and no intake for at least 2 months prior to baseline visit.
Exclusion Criteria:
- Visual field loss as demonstrated by Octopus 900 kinetic perimetry as <10 deg of remaining central visual field using stimulus sizes III4e and V4e.
- Due to distance or other reason, patients unable to travel to Philadelphia or respective centers for the treatment procedures and follow-up examinations.
- Diabetic retinopathy
- Ocular neovascularisation of any origin
- After arterial or venous occlusion
- After retinal detachment or any vitreoretinal surgery with or without implantation.
- Silicone oil tamponade
- Dry or exudative age-related macular degeneration
- Macular edema involving the foveal center as determined by SD-OCT
- All forms of glaucoma
- Any form of corneal degeneration that reduces visual acuity
- Systemic diseases that are difficult to control or manage, which could hinder regular attendance at follow-up examinations
- Patients in a permanently poor general condition, which could hinder regular attendance at follow-up examinations
- Patients in whom phosphenes are only inducible at greater than, but not including, 0.8 mA.
- Forms of mental illness related to the bipolar affective and schizoid-affective disorders, epilepsy, and all forms of dementia
- Simultaneous participation in another interventional study or history of interventions whose effect may still persist
- 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
- Any patient can be excluded from the study as determined by the Principal Investigator.
Sites / Locations
- Wills Eye Health System
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Treatment group
Sham group
Subjects in the treatment group will undergo bilateral transcorneal electrical stimulation using OkuStim device once a week for fifty-two weeks
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