Microcurrent Stimulation to Treat Macular Degeneration | NCT01790958

Studies
Microcurrent Stimulation to Treat Macular Degeneration

NCT01790958

Sponsor

Retina Institute of Hawaii

Status

Completed

Last Update Posted

Feb 13, 2013Estimated

Enrollment

50Actual

Phase

Not provided

Conditions

Retinal Diseases
Stargardt's Disease
Retinitis Pigmentosa

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2012

Primary Completion Date

Dec 2012Actual

Completion Date

Dec 2012Actual

First Submitted Date

Feb 11, 2013

First Submission Date that Met QC Criteria

Feb 11, 2013

First Posted Date

Feb 13, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 11, 2013

Last Update Posted Date

Feb 13, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
George Papastergiou, MD	Retina Institute of Hawaii	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hawaii Cataract Laser Institute - Hilo		Hilo	Hawaii	96720	United States
Retina Institute of Hawaii

Condition Browse Module

MeSH Terms

ID	Term
D012164	Retinal Diseases
D000080362	Stargardt Disease
D012174	Retinitis Pigmentosa

Ancestor Terms

ID	Term
D005128	Eye Diseases
D015785	Eye Diseases, Hereditary
D008268	Macular Degeneration
D012162	Retinal Degeneration

Browse Leaves

Not provided

Browse Branches

Not provided