Retinal DiseasesNCT01790958
Microcurrent Stimulation to Treat Macular Degeneration
An observational study of Retinal Diseases and Stargardt's Disease, run by Retina Institute of Hawaii at 4 sites in United States.
Trial summary
Microcurrent stimulation thereapy improves retinal efficiency and may restore and/or improve retinal function. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Retinal Diseases, Stargardt's Disease, Retinitis Pigmentosa
- How many people
- 50 participants
- Where
- 4 sitesUnited States
- Study dates
- Jun 2012to Dec 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with retinal disease such as Age-Related Macular Degeneration, STargardt's Disease, and Retinitis Pigmentosa
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Hawaii Cataract Laser Institute - Hilo
Hilo, Hawaii, 96720
Retina Institute of Hawaii
Honolulu, Hawaii, 96815
Hawaii Cataract Laser Institute - Maui
Kahului, Hawaii, 96732
Hawaii Cataract Laser Institute - Kona
Kailua-Kona, Hawaii, 96740
About this study
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
Microcurrent stimulation thereapy improves retinal efficiency and may restore and/or improve retinal function.
Read the 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.
- Conditions
- Retinal Diseases, Stargardt's Disease, Retinitis Pigmentosa
- Medical subject headings
- Retinal Diseases, Stargardt Disease, Retinitis Pigmentosa
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure visual acuity after receiving microcurrent stimulation treatments.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2013 (estimated)
- Study startJun 2012
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retinal DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Retina Institute of Hawaii
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- George Papastergiou, MD, Principal investigator, Retina Institute of Hawaii
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01790958
- Sponsor's protocol ID
- RIH 1009
- Status last verified
- Feb 2013
- First submitted
- 11 Feb 2013
- Last updated
- 13 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01790958
- Acronym / sponsor ID
- RIH 1009
- Conditions
- Retinal Diseases, Stargardt's Disease, Retinitis Pigmentosa
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Retina Institute of HawaiiUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 13 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Microcurrent stimulation thereapy improves retinal efficiency and may restore and/or improve retinal function.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with retinal disease such as Age-Related Macular Degeneration, STargardt's Disease, and Retinitis Pigmentosa
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Measure visual acuity after receiving microcurrent stimulation treatments.
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
George Papastergiou, MD principal investigator
Retina Institute of Hawaii
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Retinal Diseases and Stargardt's Disease, run by Retina Institute of Hawaii at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure visual acuity after receiving microcurrent stimulation treatments. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2013.