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Microcurrent Stimulation to Treat Macular Degeneration
This study has been completed.
Sponsor:
Retina Institute of Hawaii
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
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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:
Genetics Home Reference related topics:
Stargardt macular degeneration
age-related macular degeneration
cone-rod dystrophy
retinitis pigmentosa
MedlinePlus related topics:
Retinal Disorders
Genetic and Rare Diseases Information Center resources:
Retinitis Pigmentosa
Cone-rod Dystrophy
Cone-rod Dystrophy 2
Stargardt Disease
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 ]
| 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) |
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 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01790958
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
| 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 |
Additional relevant MeSH terms:
|
Retinitis Retinitis Pigmentosa Retinal Diseases Eye Diseases |
Eye Diseases, Hereditary Retinal Dystrophies Retinal Degeneration Genetic Diseases, Inborn |
ClinicalTrials.gov processed this record on June 23, 2017