Microcurrent Stimulation to Treat Macul… | Clinical Trial

Key information

Conditions

Retinal Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Eye Diseases Eye Diseases, Hereditary Genetic Diseases, Inborn Macular Degeneration Retinal Degeneration Retinal Dystrophies Retinitis Pigmentosa Stargardt Disease Stargardt's Disease

Age range

50 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hawaii Cataract Laser Institute - Hilo, Hilo, Hawaii, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Measure visual acuity after receiving microcurrent stimulation treatments.

Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Retina Institute of Hawaii

Other

Registry information

Official study 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

Important dates

Study start: 2012
Primary completion: 2012
Study completion: 2012
First posted: Feb 13, 2013
Registry last updated: Feb 13, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed