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

Not Applicable

Active, not recruiting

• Conditions: Retinitis Pigmentosa

• Registration Number: NCT02086890
• Lead Sponsor: Nova Southeastern University

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.

Study Timeline

• Study First Submitted: 2014-03-10
• Study First Submitted QC: 2014-03-11
• Study First Posted: 2014-03-13
• Study Start: 2014-08
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-09
• Last Update Posted: 2024-07-11
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 21

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Significant changes from baseline in Goldmann visual field area in both eyes	twice at baseline, then 2 weeks, 6 weeks and 12 weeks post-intervention initiation	Using Haig-Streit Octopus perimeter

Secondary Outcome Measures

Name	Time	Method
Changes in Macular edema Optical Coherence Tomography (OCT)	twice at baseline, then 2 weeks, 6 weeks and 12 weeks post-intervention initiation	Using Optical Coherence Tomography
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	Using Adaptive Sensory Technology Quick CSF
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	Using Pelli-Robson visual acuity charts
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	Using the AdaptDx by Maculogix

Trial Locations

Locations (1)

Nova Southeastern University; College of Optometry; 🇺🇸 Fort Lauderdale, Florida, United States