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OpenTrials
Completed

NCT Number: NCT01604356

Acupuncture for the Treatment of Vision Loss Due to Retinitis Pigmentosa

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.

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Key information

Conditions

Retinitis Pigmentosa Congenital, Hereditary, and Neonatal Diseases and Abnormalities Eye Diseases Eye Diseases, Hereditary Genetic Diseases, Inborn Retinal Degeneration Retinal Diseases Retinal Dystrophies

Age range

10 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Electro-acupuncture

Procedure

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 outcomes

  1. Dark-adapted (Scotopic) Full-field Stimulus Test

    Time frame: initial response within 2 weeks after completion of treatment

Secondary outcomes

  1. Goldmann visual fields

    Time frame: initial response within 2 weeks of treatment completion

  2. PC-based vision tests (visual acuity, contrast sensitivity, visual field)

    Time frame: initial response within 2 weeks of treatment completion

  3. ETDRS visual acuity

    Time frame: initial response within 2 weeks of treatment completion

  4. Pelli-Robson contrast sensitivity

    Time frame: initial response within 2 weeks of treatment completion

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
May 23, 2012
Registry last updated
Mar 4, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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