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Trial record 8 of 12 for:    "Stargardt disease"
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Microcurrent Stimulation to Treat Macular Degeneration

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Retina Institute of Hawaii
ClinicalTrials.gov Identifier:
NCT01790958
First received: February 11, 2013
Last updated: NA
Last verified: February 2013
History: No changes posted
  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:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Retina Institute of Hawaii
ClinicalTrials.gov Identifier: NCT01790958     History of Changes
Other Study ID Numbers: RIH 1009
Study First Received: February 11, 2013
Last Updated: February 11, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on June 18, 2013