Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT02086890

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

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nova Southeastern University; College of Optometry

Fort Lauderdale, Florida, 33328, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

electro-acupuncture

Device

Laser acupuncture

Device

Transcorneal Electrical Stimulation

Device

Sham Electro-acupuncture

Device

Sham laser acupuncture

Device

Sham transcorneal electrical stimulation

Device

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

Nova Southeastern University

Other

Collaborators

  • National Eye Institute (NEI)

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2026
Study completion
2027
First posted
Mar 13, 2014
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.