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Microcurrent Stimulation to Treat Macular Degeneration

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ClinicalTrials.gov Identifier: NCT01790958
Recruitment Status : Completed
First Posted : February 13, 2013
Last Update Posted : February 13, 2013
Sponsor:
Information provided by (Responsible Party):
Retina Institute of Hawaii

Study Description
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Brief Summary:
Microcurrent stimulation thereapy improves retinal efficiency and may restore and/or improve retinal function.

Condition or disease
Retinal Diseases Stargardt's Disease Retinitis Pigmentosa

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.

Study Design
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Study Type : Observational
Actual Enrollment : 50 participants
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
Study Start Date : June 2012
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

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U.S. FDA Resources

Groups and Cohorts
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Outcome Measures
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Eligibility Criteria
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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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Retina Institute of Hawaii
ClinicalTrials.gov Identifier: NCT01790958     History of Changes
Other Study ID Numbers: RIH 1009
First Posted: February 13, 2013    Key Record Dates
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