Electro-acupuncture and Transcorneal Electrical Stimulation (TES) for Retinitis Pigmentosa
Modulating Ocular/Retinal Blood Flow and Visual Function in Retinitis Pigmentosa
2 other identifiers
interventional
21
1 country
1
Brief Summary
Measures of vision in RP patients receiving promising therapy using transcorneal electrical stimulation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2014
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 10, 2014
CompletedFirst Posted
Study publicly available on registry
March 13, 2014
CompletedStudy Start
First participant enrolled
August 13, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2027
February 27, 2026
February 1, 2026
12.3 years
March 10, 2014
February 25, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Significant changes from baseline in Goldmann visual field area in both eyes
Using Haig-Streit Octopus perimeter
twice at baseline, then 2 weeks, 6 weeks and 12 weeks post-intervention initiation
Secondary Outcomes (4)
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
Changes in Macular edema Optical Coherence Tomography (OCT)
twice at baseline, then 2 weeks, 6 weeks and 12 weeks post-intervention initiation
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
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
Study Arms (6)
Electro-acupuncture
EXPERIMENTALElectro-acupuncture applied to acupoints around the eye and traditional needle acupuncture applied to acupoints throughout the body at 10 half-hour sessions over 2 weeks
Sham Electro-acupuncture
SHAM COMPARATORNo electro-acupuncture applied to non-acupoints around the eye and traditional needle acupuncture applied to non-acupoints throughout the body; i.e., to locations not on the acupuncture meridians; at 10 half-hour sessions over 2 weeks
Laser acupuncture
EXPERIMENTALLaser applied to acupoints throughout the body at 10 sessions each lasting 15 minutes over a 2 week period
Sham Laser acupuncture
SHAM COMPARATORAn inactive sham laser (red light only) applied to non-acupoints throughout the body; i.e., to locations not on the acupuncture meridians; at 10 sessions each lasting 15 minutes over a 2 week period
Transcorneal Electrical Stimulation
EXPERIMENTALTranscorneal Electrical Stimulation at 150% individual phosphene threshold applied to both eyes using DTL electrodes at 6 weekly 30 minute sessions
Sham Transcorneal Electrical Stimulation
SHAM COMPARATORSham Transcorneal Electrical Stimulation at 0% individual phosphene threshold (no stimulation) applied to both eyes using DTL electrodes at 6 weekly 30 minute sessions
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Nova Southeastern Universitylead
- National Eye Institute (NEI)collaborator
Study Sites (1)
Nova Southeastern University; College of Optometry
Fort Lauderdale, Florida, 33328, United States
Related Publications (4)
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.
PMID: 24773463BACKGROUNDBittner 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.
PMID: 29222719RESULTBittner 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.
PMID: 29130647RESULTKayser 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.
PMID: 28910168RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kenneth R Seger, OD, MSc
Faculty
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor, HPD-College of Optometry
Study Record Dates
First Submitted
March 10, 2014
First Posted
March 13, 2014
Study Start
August 13, 2014
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
December 1, 2027
Last Updated
February 27, 2026
Record last verified: 2026-02