Clinical trial NCT02086890: Electro-acupuncture and Transcorneal Electrical Stimulation (TES) for Retinitis Pigmentosa
Official title: Modulating Ocular/Retinal Blood Flow and Visual Function in Retinitis Pigmentosa
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Retinitis Pigmentosa
Keywords: retinitis pigmentosa
acupuncture
electroacupuncture
transcorneal electrical stimulation
microcurrent
Lead sponsor: Nova Southeastern University
Sponsor class: OTHER
Collaborators: name: National Eye Institute (NEI)
First posted: 2014-03-13
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Significant changes from baseline in Goldmann visual field area in both eyes
timeFrame: twice at baseline, then 2 weeks, 6 weeks and 12 weeks post-intervention initiation
Secondary outcomes:
measure: Significant changes from baseline in best-corrected ETDRS visual acuity at both 2 weeks and 6 weeks post-intervention initiation
timeFrame: twice at baseline, then 2 weeks, 6 weeks and 12 weeks post-intervention initiation
measure: Changes in Macular edema Optical Coherence Tomography (OCT)
timeFrame: twice at baseline, then 2 weeks, 6 weeks and 12 weeks post-intervention initiation
measure: Significant changes from baseline in contrast sensitivity at both 2 weeks and 6 weeks post-intervention initiation
timeFrame: twice at baseline, then 2 weeks, 6 weeks and 12 weeks post-intervention initiation
measure: Significant changes from baseline in Dark adaptation function at both 2 weeks and 6 weeks post-intervention initiation
timeFrame: twice at baseline, then 2 weeks, 6 weeks and 12 weeks post-intervention initiation
Other outcomes:
Locations:
city: Fort Lauderdale
country: United States
facility: Nova Southeastern University; College of Optometry
state: Florida
Study officials:
affiliation: Faculty
name: Kenneth R Seger, OD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bittner AK, Gould JM, Rosenfarb A, Rozanski C, Dagnelie G. A pilot study of an acupuncture protocol to improve visual function in retinitis pigmentosa patients. Clin Exp Optom. 2014 May;97(3):240-7. doi: 10.1111/cxo.12117. Epub 2013 Oct 29.
citation: Bittner AK, Seger K. Longevity of visual improvements following transcorneal electrical stimulation and efficacy of retreatment in three individuals with retinitis pigmentosa. Graefes Arch Clin Exp Ophthalmol. 2018 Feb;256(2):299-306. doi: 10.1007/s00417-017-3858-8. Epub 2017 Dec 8.
citation: Bittner AK, Seger K, Salveson R, Kayser S, Morrison N, Vargas P, Mendelsohn D, Han J, Bi H, Dagnelie G, Benavente A, Ramella-Roman J. Randomized controlled trial of electro-stimulation therapies to modulate retinal blood flow and visual function in retinitis pigmentosa. Acta Ophthalmol. 2018 May;96(3):e366-e376. doi: 10.1111/aos.13581. Epub 2017 Nov 11.
citation: Kayser S, Vargas P, Mendelsohn D, Han J, Bi H, Benavente A, Bittner AK. Reduced Central Retinal Artery Blood Flow Is Related to Impaired Central Visual Function in Retinitis Pigmentosa Patients. Curr Eye Res. 2017 Nov;42(11):1503-1510. doi: 10.1080/02713683.2017.1338350. Epub 2017 Sep 14.