We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Microcurrent Stimulation to Treat Macular Degeneration

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01790958
First Posted: February 13, 2013
Last Update Posted: February 13, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Retina Institute of Hawaii
  Purpose
Microcurrent stimulation thereapy improves retinal efficiency and may restore and/or improve retinal function.

Condition
Retinal Diseases Stargardt's Disease Retinitis Pigmentosa

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
Official Title: An Observational, Multi-Center Phase 1 Study of the Safety and Effectiveness of Frequency Specific Microcurrent Stimulation as an Alternative Treatment for Retinal Diseases

Resource links provided by NLM:


Further study details as provided by Retina Institute of Hawaii:

Primary Outcome Measures:
  • Measure visual acuity after receiving microcurrent stimulation treatments. [ Time Frame: 6 months ]

Enrollment: 50
Study Start Date: June 2012
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Detailed Description:
This is an observational study in which data will be collected from a group of patients with retinal diseases such as Dry Macular Degeneration, RetinitisPigmentosa, and Stargardt's Disease, who have opted to receive Microcurrent Stimulation Therapy as an alternative treatment for their retinal condition.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients with retinal disease such as Age-Related Macular Degeneration, STargardt's Disease, and Retinitis Pigmentosa
Criteria

Inclusion Criteria:

  • Ability to provide written consent and comply with follow up visits
  • Age 40 years or older
  • ETDRS best corrected visual acuity better than 5 letters
  • History of Dry Age Relted Macular Degeneration; Retinitis Pigmentosa; Stargardt's disease
  • No Anti-VEGF treatments for at least 3 months prior to study
  • No new antioxidant/vitamin supplementation for at least 3 months prior to study

Exclusion Criteria:

  • History of Non-Compliance with regular medical visits
  • Significant media opacities (exclude NS 4+) that may interfere with assessing visual acuity
  • Presence of pigment epithelial tears or rips
  • Known serious allergies to fluorescein dye
  • Presence of retinal neovascularization
  • Any treatment with an investigation agent in the past 30 days
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01790958


Locations
United States, Hawaii
Hawaii Cataract Laser Institute - Hilo
Hilo, Hawaii, United States, 96720
Retina Institute of Hawaii
Honolulu, Hawaii, United States, 96815
Hawaii Cataract Laser Institute - Maui
Kahului, Hawaii, United States, 96732
Hawaii Cataract Laser Institute - Kona
Kailua-Kona, Hawaii, United States, 96740
Sponsors and Collaborators
Retina Institute of Hawaii
Investigators
Principal Investigator: George Papastergiou, MD Retina Institute of Hawaii
  More Information

Responsible Party: Retina Institute of Hawaii
ClinicalTrials.gov Identifier: NCT01790958     History of Changes
Other Study ID Numbers: RIH 1009
First Submitted: February 11, 2013
First Posted: February 13, 2013
Last Update Posted: February 13, 2013
Last Verified: February 2013

Additional relevant MeSH terms:
Retinitis
Retinitis Pigmentosa
Cone-Rod Dystrophies
Retinal Diseases
Eye Diseases
Eye Diseases, Hereditary
Retinal Dystrophies
Retinal Degeneration
Genetic Diseases, Inborn