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Acupuncture for the Treatment of Vision Loss Due to Retinitis Pigmentosa

Primary Purpose

Retinitis Pigmentosa

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Electro-acupuncture
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Retinitis Pigmentosa focused on measuring retinitis pigmentosa

Eligibility Criteria

10 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Johns Hopkins University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Electro-acupuncture

Arm Description

Outcomes

Primary Outcome Measures

Dark-adapted (Scotopic) Full-field Stimulus Test

Secondary Outcome Measures

Goldmann visual fields
PC-based vision tests (visual acuity, contrast sensitivity, visual field)
ETDRS visual acuity
Pelli-Robson contrast sensitivity

Full Information

First Posted
May 21, 2012
Last Updated
March 3, 2014
Sponsor
Johns Hopkins University
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1. Study Identification

Unique Protocol Identification Number
NCT01604356
Brief Title
Acupuncture for the Treatment of Vision Loss Due to Retinitis Pigmentosa
Official Title
Acupuncture for the Treatment of Vision Loss Due to Retinitis Pigmentosa
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Johns Hopkins University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retinitis Pigmentosa
Keywords
retinitis pigmentosa

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Electro-acupuncture
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Electro-acupuncture
Intervention Description
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.
Primary Outcome Measure Information:
Title
Dark-adapted (Scotopic) Full-field Stimulus Test
Time Frame
initial response within 2 weeks after completion of treatment
Secondary Outcome Measure Information:
Title
Goldmann visual fields
Time Frame
initial response within 2 weeks of treatment completion
Title
PC-based vision tests (visual acuity, contrast sensitivity, visual field)
Time Frame
initial response within 2 weeks of treatment completion
Title
ETDRS visual acuity
Time Frame
initial response within 2 weeks of treatment completion
Title
Pelli-Robson contrast sensitivity
Time Frame
initial response within 2 weeks of treatment completion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States

12. IPD Sharing Statement

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Acupuncture for the Treatment of Vision Loss Due to Retinitis Pigmentosa

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