Retinitis Pigmentosa
Conditions
Keywords
retinitis pigmentosa, acupuncture, electroacupuncture, transcorneal electrical stimulation, microcurrent
Brief summary
Measures of vision in RP patients receiving promising therapy using transcorneal electrical stimulation.
Detailed description
Retinitis pigmentosa (RP) is a slowly progressive retinal degeneration for which there is no proven treatment. Patients are interested in trying alternative therapies to try to reduce their vision loss, but only limited research evidence exists to support their use and potential benefit. The goal of this research project is to gain a better understanding of possible changes in ocular and retinal blood flow and measures of vision in RP patients receiving two promising therapies, electroacupuncture and transcorneal electrical stimulation. We are currently only doing transcorneal electrical stimulation.
Interventions
DEVICEElectro-acupuncture
DEVICELaser Acupuncture
DEVICESham Electro-acupuncture
DEVICESham laser acupuncture
DEVICESham transcorneal electrical stimulation
Sponsors
Nova Southeastern University
National Eye Institute (NEI)
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 18+ * Diagnosis of retinitis pigmentosa (RP) * Best-corrected visual acuity better than 20/400 in at least one eye * More than 20% loss of Goldmann Visual Field area (III4e test target) in at least one eye * Able and willing to participate in all study visits for a \~4-6 month period * Provide informed consent
Exclusion criteria
* Very severe vision losses in both eyes (e.g., hand motions or light perception only) with difficulty performing the proposed vision tests * Vision loss due to ocular diseases other than RP, cystoid macular edema, or cataracts * Schedules do not permit participation in all study visits * Previous acupuncture or TES treatment for RP * Inability to understand study procedures or communicate responses to visual stimuli in a consistent manner (cognitive impairment) * Dementia; Long or short-term memory loss * Unable to read or speak English * Smoking, excessive alcohol, or illegal drug use * Receiving current psychiatric care (i.e. unstable emotional and mental health status) * History of excessive bleeding * Reduced general health and/or systemic medications that may diminish the potential response to the electroacupuncture treatments * Implanted cardiac pacemaker * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Significant changes from baseline in Goldmann visual field area in both eyes | twice at baseline, then 2 weeks, 6 weeks and 12 weeks post-intervention initiation | Using Haig-Streit Octopus perimeter |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Significant changes from baseline in best-corrected ETDRS visual acuity at both 2 weeks and 6 weeks post-intervention initiation | twice at baseline, then 2 weeks, 6 weeks and 12 weeks post-intervention initiation | Using Pelli-Robson visual acuity charts |
| Changes in Macular edema Optical Coherence Tomography (OCT) | twice at baseline, then 2 weeks, 6 weeks and 12 weeks post-intervention initiation | Using Optical Coherence Tomography |
| Significant changes from baseline in contrast sensitivity at both 2 weeks and 6 weeks post-intervention initiation | twice at baseline, then 2 weeks, 6 weeks and 12 weeks post-intervention initiation | Using Adaptive Sensory Technology Quick CSF |
| Significant changes from baseline in Dark adaptation function at both 2 weeks and 6 weeks post-intervention initiation | twice at baseline, then 2 weeks, 6 weeks and 12 weeks post-intervention initiation | Using the AdaptDx by Maculogix |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORKenneth R Seger, OD, MSc
Faculty
Outcome results
None listed