Clinical Trial: Electro-acupuncture and Transcorneal Electrical Stimulation (TES) for the Treatment of Vision Loss Due to Retinitis Pigmentosa

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

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

Brief Summary: 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.

Detailed Summary:
Sponsor: Nova Southeastern University

Current Primary Outcome: Significant Changes from baseline in Ocular and Retinal Blood Flow at 2 weeks and 6 weeks post-intervention initiation [ Time Frame: twice at baseline, then 2 weeks, 6 weeks and 12 weeks post-intervention initiation ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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
  • Significant changes from baseline in multifocal electroretinogram (ERG) 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 Goldmann visual field area 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 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 ]
  • 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 ]
  • Optical Coherence Tomography (OCT) [ Time Frame: twice at baseline, then 2 weeks, 6 weeks and 12 weeks post-intervention initiation ]
    changes in macular edema


Original Secondary Outcome: Same as current

Information By: Nova Southeastern University

Dates:
Date Received: March 10, 2014
Date Started: August 2014
Date Completion: June 2018
Last Updated: April 6, 2017
Last Verified: April 2017