Acupuncture for the Treatment of Vision Loss Due to Retinitis Pigmentosa

March 3, 2014 updated by: Ava Bittner, Johns Hopkins University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

19

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Dark-adapted (Scotopic) Full-field Stimulus Test
Time Frame: initial response within 2 weeks after completion of treatment
initial response within 2 weeks after completion of treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Goldmann visual fields
Time Frame: initial response within 2 weeks of treatment completion
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
initial response within 2 weeks of treatment completion
ETDRS visual acuity
Time Frame: initial response within 2 weeks of treatment completion
initial response within 2 weeks of treatment completion
Pelli-Robson contrast sensitivity
Time Frame: initial response within 2 weeks of treatment completion
initial response within 2 weeks of treatment completion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

May 21, 2012

First Submitted That Met QC Criteria

May 22, 2012

First Posted (Estimate)

May 23, 2012

Study Record Updates

Last Update Posted (Estimate)

March 4, 2014

Last Update Submitted That Met QC Criteria

March 3, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NA_00050691

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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