Clinical trial NCT01604356: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Retinitis Pigmentosa
Keywords: retinitis pigmentosa
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2012-05-23
Enrollment: 19
Sex: ALL
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Dark-adapted (Scotopic) Full-field Stimulus Test
timeFrame: initial response within 2 weeks after completion of treatment
Secondary outcomes:
measure: Goldmann visual fields
timeFrame: initial response within 2 weeks of treatment completion
measure: PC-based vision tests (visual acuity, contrast sensitivity, visual field)
timeFrame: initial response within 2 weeks of treatment completion
measure: ETDRS visual acuity
timeFrame: initial response within 2 weeks of treatment completion
measure: Pelli-Robson contrast sensitivity
timeFrame: initial response within 2 weeks of treatment completion
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
Study officials:
References: