Acupuncture for the Treatment of Vision Loss Due to Retinitis Pigmentosa

Retinitis Pigmentosa Clinical Trial

Official title:

Acupuncture for the Treatment of Vision Loss Due to Retinitis Pigmentosa

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01604356
• Other study ID #: NA_00050691
• Status: Completed
• Phase: Phase 1
• First received: May 21, 2012
• Last updated: March 3, 2014
• Start date: April 2012
• Est. completion date: December 2013

Study information

• Verified date: March 2014
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 10 Years and older

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Retinitis
• Retinitis Pigmentosa

Intervention

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.

Locations

Country	Name	City	State
United States	Johns Hopkins University	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dark-adapted (Scotopic) Full-field Stimulus Test		initial response within 2 weeks after completion of treatment	Yes
Secondary	Goldmann visual fields		initial response within 2 weeks of treatment completion	Yes
Secondary	PC-based vision tests (visual acuity, contrast sensitivity, visual field)		initial response within 2 weeks of treatment completion	Yes
Secondary	ETDRS visual acuity		initial response within 2 weeks of treatment completion	Yes
Secondary	Pelli-Robson contrast sensitivity		initial response within 2 weeks of treatment completion	Yes