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Acupuncture for the Treatment of Vision Loss Due to Retinitis Pigmentosa

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ClinicalTrials.gov Identifier: NCT01604356
Recruitment Status : Completed
First Posted : May 23, 2012
Last Update Posted : March 4, 2014
Sponsor:
Information provided by (Responsible Party):
Ava Bittner, Johns Hopkins University

Tracking Information
First Submitted Date  ICMJE May 21, 2012
First Posted Date  ICMJE May 23, 2012
Last Update Posted Date March 4, 2014
Study Start Date  ICMJE April 2012
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 22, 2012)
Dark-adapted (Scotopic) Full-field Stimulus Test [ Time Frame: initial response within 2 weeks after completion of treatment ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01604356 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 22, 2012)
  • Goldmann visual fields [ Time Frame: initial response within 2 weeks of treatment completion ]
  • PC-based vision tests (visual acuity, contrast sensitivity, visual field) [ Time Frame: initial response within 2 weeks of treatment completion ]
  • ETDRS visual acuity [ Time Frame: initial response within 2 weeks of treatment completion ]
  • Pelli-Robson contrast sensitivity [ Time Frame: initial response within 2 weeks of treatment completion ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE Acupuncture for the Treatment of Vision Loss Due to Retinitis Pigmentosa
Official Title  ICMJE Acupuncture for the Treatment of Vision Loss Due to Retinitis Pigmentosa
Brief Summary Retinitis Pigmentosa (RP) patients are interested in trying alternative therapies to attempt to slow, halt or reverse the retinal disease process, and claim success with some approaches such as acupuncture, but this potential treatment has not been put to the test of objective, rigorous scientific study conducted in western society. In this pilot study, the investigators aim to evaluate an acupuncture treatment tailored to the RP population for its feasibility to improve visual function, specifically visual field and dark adaptation. The study results may provide a basis for eye care providers' recommendations to RP patients regarding whether to consider acupuncture as a potential treatment modality. If our hypotheses regarding improvements in vision beyond typical test variability are supported, our future research goals include the conduct of a larger clinical trial with involving randomization and a placebo control for acupuncture in RP.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Retinitis Pigmentosa
Intervention  ICMJE Procedure: Electro-acupuncture
Ten treatment sessions at our center during a two week period (5 sessions per week). Each session will last approximately 30 minutes. The intervention will involve the placement of acupuncture needles in a standard set of points across all patients, located on the head, around the eyes, on the abdomen, on the hands, feet, arms and legs. An electro-acupuncture device [Transcutaneous electrical nerve stimulator (TENS) unit by Lhasa OMS Inc.; model AWQ-104L] and will be used on four of the acupuncture points (two per session) located on the forehead, and side of the face/temple.
Study Arms Experimental: Electro-acupuncture
Intervention: Procedure: Electro-acupuncture
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 3, 2014)
19
Original Estimated Enrollment  ICMJE
 (submitted: May 22, 2012)
12
Actual Study Completion Date December 2013
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age 10+
  • Diagnosis of retinitis pigmentosa
  • Best-corrected visual acuity better than 20/400 in at least one eye
  • More than 20% loss of Goldmann Visual Field area (III4e) in at least one eye
  • Able and willing to participate in all study visits in Baltimore for the 8-week program
  • 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 treatment in the last 6 months
  • 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, substance abuse, or illegal drug use
  • Receiving current psychiatric care (i.e. unstable emotional and mental health status)
  • History of excessive bleeding
Sex/Gender
Sexes Eligible for Study: All
Ages 10 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01604356
Other Study ID Numbers  ICMJE NA_00050691
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Ava Bittner, Johns Hopkins University
Study Sponsor  ICMJE Johns Hopkins University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Johns Hopkins University
Verification Date March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP