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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Retinitis Pigmentosa Procedure: Electro-acupuncture Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Acupuncture for the Treatment of Vision Loss Due to Retinitis Pigmentosa
Study Start Date : April 2012
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acupuncture

Arms and Interventions
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Arm Intervention/treatment
Experimental: Electro-acupuncture 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.


Outcome Measures
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Primary Outcome Measures :
  1. Dark-adapted (Scotopic) Full-field Stimulus Test [ Time Frame: initial response within 2 weeks after completion of treatment ]

Secondary Outcome Measures :
  1. Goldmann visual fields [ Time Frame: initial response within 2 weeks of treatment completion ]
  2. PC-based vision tests (visual acuity, contrast sensitivity, visual field) [ Time Frame: initial response within 2 weeks of treatment completion ]
  3. ETDRS visual acuity [ Time Frame: initial response within 2 weeks of treatment completion ]
  4. Pelli-Robson contrast sensitivity [ Time Frame: initial response within 2 weeks of treatment completion ]

Eligibility Criteria
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Ages Eligible for Study:   10 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01604356


Locations
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Johns Hopkins University
More Information
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Responsible Party: Ava Bittner, Principal Investigator, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01604356     History of Changes
Other Study ID Numbers: NA_00050691
First Posted: May 23, 2012    Key Record Dates
Last Update Posted: March 4, 2014
Last Verified: March 2014

Keywords provided by Ava Bittner, Johns Hopkins University:
retinitis pigmentosa

Additional relevant MeSH terms:
Retinitis
Retinitis Pigmentosa
Retinal Diseases
Eye Diseases
 Eye Diseases, Hereditary
Retinal Dystrophies
Retinal Degeneration
Genetic Diseases, Inborn