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Acupuncture for the Treatment of Vision Loss Due to Retinitis Pigmentosa

This study is currently recruiting participants.
Verified May 2012 by Johns Hopkins University
Sponsor:
Information provided by (Responsible Party):
Ava Bittner, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01604356
First received: May 21, 2012
Last updated: May 22, 2012
Last verified: May 2012
History of Changes
  Purpose

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 Intervention Phase
Retinitis Pigmentosa
 Procedure: Electro-acupuncture
 Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Acupuncture for the Treatment of Vision Loss Due to Retinitis Pigmentosa

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Dark-adapted (Scotopic) Full-field Stimulus Test [ Time Frame: initial response within 2 weeks after completion of treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Goldmann visual fields [ Time Frame: initial response within 2 weeks of treatment completion ] [ Designated as safety issue: Yes ]
  • PC-based vision tests (visual acuity, contrast sensitivity, visual field) [ Time Frame: initial response within 2 weeks of treatment completion ] [ Designated as safety issue: Yes ]
  • ETDRS visual acuity [ Time Frame: initial response within 2 weeks of treatment completion ] [ Designated as safety issue: Yes ]
  • Pelli-Robson contrast sensitivity [ Time Frame: initial response within 2 weeks of treatment completion ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 12
Study Start Date: April 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   10 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01604356

Contacts
Contact: Ava K Bittner, OD, PhD 410-502-6430 abittne1@jhmi.edu

Locations
United States, Maryland
Johns Hopkins University Recruiting
Baltimore, Maryland, United States, 21287
Contact: Ava K Bittner, OD, PhD     410-502-6430     abittne1@jhmi.edu    
Sponsors and Collaborators
Johns Hopkins University
  More Information

No publications provided

Responsible Party: Ava Bittner, Principal Investigator, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01604356     History of Changes
Other Study ID Numbers: NA_00050691
Study First Received: May 21, 2012
Last Updated: May 22, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Johns Hopkins University:
retinitis pigmentosa

Additional relevant MeSH terms:
Retinitis
Retinitis Pigmentosa
Blindness
Retinal Diseases
Eye Diseases
Eye Diseases, Hereditary
Retinal Dystrophies
 Retinal Degeneration
Genetic Diseases, Inborn
Vision Disorders
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on May 23, 2013