Acupuncture for the Treatment of Vision Loss Due to Retinitis Pigmentosa

Acupuncture for the Treatment of Vision Loss Due to Retinitis Pigmentosa

Sponsors

Lead Sponsor: Johns Hopkins University

Source Johns Hopkins University
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.

Overall Status Completed
Start Date April 2012
Completion Date December 2013
Primary Completion Date December 2013
Phase Phase 1
Study Type Interventional
Primary Outcome
Measure Time Frame
Dark-adapted (Scotopic) Full-field Stimulus Test initial response within 2 weeks after completion of treatment
Secondary Outcome
Measure Time Frame
Goldmann visual fields initial response within 2 weeks of treatment completion
PC-based vision tests (visual acuity, contrast sensitivity, visual field) initial response within 2 weeks of treatment completion
ETDRS visual acuity initial response within 2 weeks of treatment completion
Pelli-Robson contrast sensitivity initial response within 2 weeks of treatment completion
Enrollment 19
Condition
Intervention

Intervention Type: Procedure

Intervention Name: Electro-acupuncture

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.

Arm Group Label: Electro-acupuncture

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

Gender: All

Minimum Age: 10 Years

Maximum Age: N/A

Healthy Volunteers: No

Location
Facility: Johns Hopkins University
Location Countries

United States

Verification Date

March 2014

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Johns Hopkins University

Investigator Full Name: Ava Bittner

Investigator Title: Principal Investigator

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: Electro-acupuncture

Type: Experimental

Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov