Electro-acupuncture and Transcorneal Electrical Stimulation (TES) for Retinitis Pigmentosa

February 25, 2026 updated by: Kenneth Seger, Nova Southeastern University

Modulating Ocular/Retinal Blood Flow and Visual Function in Retinitis Pigmentosa

Measures of vision in RP patients receiving promising therapy using transcorneal electrical stimulation.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

21

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Fort Lauderdale, Florida, United States, 33328
        • Nova Southeastern University; College of Optometry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Electro-acupuncture
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
Device: Electro-acupuncture
Sham Comparator: Sham Electro-acupuncture
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
Device: Sham Electro-acupuncture
Experimental: Laser acupuncture
Laser applied to acupoints throughout the body at 10 sessions each lasting 15 minutes over a 2 week period
Device: Laser Acupuncture
Sham Comparator: Sham Laser acupuncture
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
Device: Sham laser acupuncture
Experimental: Transcorneal Electrical Stimulation
Transcorneal Electrical Stimulation at 150% individual phosphene threshold applied to both eyes using DTL electrodes at 6 weekly 30 minute sessions
Device: Transcorneal Electrical Stimulation
Sham Comparator: Sham Transcorneal Electrical Stimulation
Sham Transcorneal Electrical Stimulation at 0% individual phosphene threshold (no stimulation) applied to both eyes using DTL electrodes at 6 weekly 30 minute sessions
Device: Sham transcorneal electrical stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
twice at baseline, then 2 weeks, 6 weeks and 12 weeks post-intervention initiation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Using the AdaptDx by Maculogix
twice at baseline, then 2 weeks, 6 weeks and 12 weeks post-intervention initiation
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
Using Pelli-Robson visual acuity charts
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
Using Adaptive Sensory Technology Quick CSF
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
Using Optical Coherence Tomography
twice at baseline, then 2 weeks, 6 weeks and 12 weeks post-intervention initiation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nova Southeastern University

Collaborators

National Eye Institute (NEI)

Investigators

  • Principal Investigator: Kenneth R Seger, OD, MSc, Faculty

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 13, 2014

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

March 10, 2014

First Submitted That Met QC Criteria

March 11, 2014

First Posted (Estimated)

March 13, 2014

Study Record Updates

Last Update Posted (Actual)

February 27, 2026

Last Update Submitted That Met QC Criteria

February 25, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 01311402F
  • R21EY023720 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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