Microcurrent Stimulation to Treat Macular Degeneration

Retinitis Pigmentosa Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01790958
• Other study ID #: RIH 1009
• Status: Completed
• Phase: N/A
• First received: February 11, 2013
• Last updated: February 11, 2013
• Start date: June 2012
• Est. completion date: December 2012

Study information

• Verified date: February 2013
• Source: Retina Institute of Hawaii
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years and older

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Retinal Diseases
• Retinitis Pigmentosa
• Stargardt's Disease

Locations

Country	Name	City	State
United States	Hawaii Cataract Laser Institute - Hilo	Hilo	Hawaii
United States	Retina Institute of Hawaii	Honolulu	Hawaii
United States	Hawaii Cataract Laser Institute - Maui	Kahului	Hawaii
United States	Hawaii Cataract Laser Institute - Kona	Kailua-Kona	Hawaii

Sponsors (1)

Lead Sponsor	Collaborator
Retina Institute of Hawaii

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure visual acuity after receiving microcurrent stimulation treatments.		6 months	No