Acupuncture for the Treatment of Vision Loss Due to Retinitis Pigmentosa

Phase 1

Completed

• Conditions: Retinitis Pigmentosa
• Interventions: Procedure: Electro-acupuncture

• Registration Number: NCT01604356
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04
• Study First Submitted: 2012-05-21
• Study First Submitted QC: 2012-05-22
• Study First Posted: 2012-05-23
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2014-03
• Last Update Submitted: 2014-03-03
• Last Update Posted: 2014-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Electro-acupuncture	Electro-acupuncture	-

Primary Outcome Measures

Name	Time	Method
Dark-adapted (Scotopic) Full-field Stimulus Test	initial response within 2 weeks after completion of treatment

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Johns Hopkins University; 🇺🇸 Baltimore, Maryland, United States