Microcurrent Stimulation to Treat Macular Degeneration

February 11, 2013 updated by: Retina Institute of Hawaii

An Observational, Multi-Center Phase 1 Study of the Safety and Effectiveness of Frequency Specific Microcurrent Stimulation as an Alternative Treatment for Retinal Diseases

Microcurrent stimulation thereapy improves retinal efficiency and may restore and/or improve retinal function.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Hawaii
      • Hilo, Hawaii, United States, 96720
        • Hawaii Cataract Laser Institute - Hilo
      • Honolulu, Hawaii, United States, 96815
        • Retina Institute of Hawaii
      • Kahului, Hawaii, United States, 96732
        • Hawaii Cataract Laser Institute - Maui
      • Kailua-Kona, Hawaii, United States, 96740
        • Hawaii Cataract Laser Institute - Kona

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with retinal disease such as Age-Related Macular Degeneration, STargardt's Disease, and Retinitis Pigmentosa

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Measure visual acuity after receiving microcurrent stimulation treatments.
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Retina Institute of Hawaii

Investigators

  • Principal Investigator: George Papastergiou, MD, Retina Institute of Hawaii

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

February 11, 2013

First Submitted That Met QC Criteria

February 11, 2013

First Posted (Estimate)

February 13, 2013

Study Record Updates

Last Update Posted (Estimate)

February 13, 2013

Last Update Submitted That Met QC Criteria

February 11, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RIH 1009

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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