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

Retinitis Pigmentosa Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02086890
• Other study ID #: 01311402F
• Secondary ID: R21EY023720
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 2014
• Est. completion date: December 2024

Study information

• Verified date: June 2023
• Source: Nova Southeastern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 21
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Retinitis
• Retinitis Pigmentosa

Intervention

Device:
• Electro-acupuncture

• Laser Acupuncture

• Transcorneal Electrical Stimulation

• Sham Electro-acupuncture

• Sham laser acupuncture

• Sham transcorneal electrical stimulation

Locations

Country	Name	City	State
United States	Nova Southeastern University; College of Optometry	Fort Lauderdale	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Nova Southeastern University	National Eye Institute (NEI)

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Bittner 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 retini — View Citation

Bittner 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- — View Citation

Kayser 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: 10.1080/027136 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	twice at baseline, then 2 weeks, 6 weeks and 12 weeks post-intervention initiation
Secondary	Changes in Macular edema Optical Coherence Tomography (OCT)	Using Optical Coherence Tomography	twice at baseline, then 2 weeks, 6 weeks and 12 weeks post-intervention initiation
Secondary	Significant changes from baseline in contrast sensitivity at both 2 weeks and 6 weeks post-intervention initiation	Using Adaptive Sensory Technology Quick CSF	twice at baseline, then 2 weeks, 6 weeks and 12 weeks post-intervention initiation
Secondary	Significant changes from baseline in Dark adaptation function at both 2 weeks and 6 weeks post-intervention initiation	Using the AdaptDx by Maculogix	twice at baseline, then 2 weeks, 6 weeks and 12 weeks post-intervention initiation