Retinitis PigmentosaNCT02086890
Electro-acupuncture and Transcorneal Electrical Stimulation (TES) for Retinitis Pigmentosa
A study testing Electro-acupuncture, Laser Acupuncture and Transcorneal Electrical Stimulation in people with Retinitis Pigmentosa, run by Nova Southeastern University at 1 site in United States.
Trial summary
Measures of vision in RP patients receiving promising therapy using transcorneal electrical stimulation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Retinitis Pigmentosa
- What is being tested?
- Electro-acupuncture, Laser Acupuncture and Transcorneal Electrical Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Aug 2014to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Nova Southeastern University; College of Optometry
Fort Lauderdale, Florida, 33328
About this study
Official title: Modulating Ocular/Retinal Blood Flow and Visual Function in Retinitis Pigmentosa
Measures of vision in RP patients receiving promising therapy using transcorneal electrical stimulation.
Read the 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.
- Conditions
- Retinitis Pigmentosa
- Being tested
- Electro-acupuncture, Laser Acupuncture, Transcorneal Electrical Stimulation, Sham Electro-acupuncture, Sham laser acupuncture
- Keywords
- retinitis pigmentosa, acupuncture, electroacupuncture, transcorneal electrical stimulation, microcurrent
- Medical subject headings
- Retinitis Pigmentosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electro-acupunctureDevice
Laser AcupunctureDevice
Transcorneal Electrical StimulationDevice
Sham Electro-acupunctureDevice
Sham laser acupunctureDevice
Sham transcorneal electrical stimulationDevice
| Study group | Role | What they receive |
|---|---|---|
| Electro-acupuncture | Experimental | Electro-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 Receives: Device: Electro-acupuncture |
| Sham Electro-acupuncture | Sham comparator | No 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 Receives: Device: Sham Electro-acupuncture |
| Laser acupuncture | Experimental | Laser applied to acupoints throughout the body at 10 sessions each lasting 15 minutes over a 2 week period Receives: Device: Laser Acupuncture |
| Sham Laser acupuncture | Sham comparator | An 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 Receives: Device: Sham laser acupuncture |
| Transcorneal Electrical Stimulation | Experimental | Transcorneal Electrical Stimulation at 150% individual phosphene threshold applied to both eyes using DTL electrodes at 6 weekly 30 minute sessions Receives: Device: Transcorneal Electrical Stimulation |
| Sham Transcorneal Electrical Stimulation | Sham comparator | Sham Transcorneal Electrical Stimulation at 0% individual phosphene threshold (no stimulation) applied to both eyes using DTL electrodes at 6 weekly 30 minute sessions Receives: Device: Sham transcorneal electrical stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Significant changes from baseline in Goldmann visual field area in both eyes
Using Haig-Streit Octopus perimeter
Measured: 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
Using Pelli-Robson visual acuity charts
Measured: twice at baseline, then 2 weeks, 6 weeks and 12 weeks post-intervention initiation
Changes in Macular edema Optical Coherence Tomography (OCT)
Using Optical Coherence Tomography
Measured: 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
Using Adaptive Sensory Technology Quick CSF
Measured: 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
Using the AdaptDx by Maculogix
Measured: twice at baseline, then 2 weeks, 6 weeks and 12 weeks post-intervention initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2014 (estimated)
- Study start13 Aug 2014
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Retinitis PigmentosaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 21 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nova Southeastern University
- Sponsor type
- University, hospital or other
- Collaborators
- National Eye Institute (NEI)
- Responsible party
- Principal investigator, Kenneth Seger, Nova Southeastern University
- Investigators
- Kenneth R Seger, OD, MSc, Principal investigator, Faculty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02086890
- Sponsor's protocol ID
- 01311402F
- Other IDs
- R21EY023720
- Status last verified
- Feb 2026
- First submitted
- 10 Mar 2014
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 24773463Bittner 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.
PubMed 29222719Bittner 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.
PubMed 29130647Kayser 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.
PubMed 28910168
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modulating Ocular/Retinal Blood Flow and Visual Function in Retinitis Pigmentosa
- ClinicalTrials.gov ID
- NCT02086890
- Acronym / sponsor ID
- 01311402F
- Conditions
- Retinitis Pigmentosa
- Keywords
- retinitis pigmentosa, acupuncture, electroacupuncture, transcorneal electrical stimulation, microcurrent
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 21 participants (estimated)
- Lead sponsor
- Nova Southeastern UniversityUniversity, hospital or other
- Collaborators
- National Eye Institute (NEI)
- Study start
- 13 Aug 2014 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 13 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Electro-acupuncture | Experimental | Device: Electro-acupunctureElectro-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 comparator | Device: Sham Electro-acupunctureNo 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 | Experimental | Device: Laser AcupunctureLaser applied to acupoints throughout the body at 10 sessions each lasting 15 minutes over a 2 week period |
| Sham Laser acupuncture | Sham comparator | Device: Sham laser acupunctureAn 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 | Experimental | Device: Transcorneal Electrical StimulationTranscorneal 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 comparator | Device: Sham transcorneal electrical stimulationSham Transcorneal Electrical Stimulation at 0% individual phosphene threshold (no stimulation) applied to both eyes using DTL electrodes at 6 weekly 30 minute sessions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (13 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electro-acupuncture | Device | Electro-acupuncture |
| Laser Acupuncture | Device | Laser acupuncture |
| Transcorneal Electrical Stimulation | Device | Transcorneal Electrical Stimulation |
| Sham Electro-acupuncture | Device | Sham Electro-acupuncture |
| Sham laser acupuncture | Device | Sham Laser acupuncture |
| Sham transcorneal electrical stimulation | Device | Sham Transcorneal Electrical Stimulation |
Primary outcome
Significant changes from baseline in Goldmann visual field area in both eyes
Time frame: twice at baseline, then 2 weeks, 6 weeks and 12 weeks post-intervention initiation
Using Haig-Streit Octopus perimeter
4 secondary outcomes
Significant changes from baseline in best-corrected ETDRS visual acuity at both 2 weeks and 6 weeks post-intervention initiation
Time frame: twice at baseline, then 2 weeks, 6 weeks and 12 weeks post-intervention initiation
Changes in Macular edema Optical Coherence Tomography (OCT)
Time frame: 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
Time frame: 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
Time frame: twice at baseline, then 2 weeks, 6 weeks and 12 weeks post-intervention initiation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Background: PubMed 24773463Bittner 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.
- Results publication: PubMed 29222719Bittner 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.
- Results publication: PubMed 29130647Bittner 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.
- Results publication: PubMed 28910168Kayser 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kenneth R Seger, OD, MSc principal investigator
Faculty
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electro-acupuncture, Laser Acupuncture and Transcorneal Electrical Stimulation in people with Retinitis Pigmentosa, run by Nova Southeastern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Significant changes from baseline in Goldmann visual field area in both eyes (time frame: twice at baseline, then 2 weeks, 6 weeks and 12 weeks post-intervention initiation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02086890, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.