NCT01790958

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2012

Shorter than P25 for all trials

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 11, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 13, 2013

Completed
Last Updated

February 13, 2013

Status Verified

February 1, 2013

Enrollment Period

6 months

First QC Date

February 11, 2013

Last Update Submit

February 11, 2013

Conditions

Retinal DiseasesStargardt's DiseaseRetinitis Pigmentosa

Outcome Measures

Primary Outcomes (1)

  • Measure visual acuity after receiving microcurrent stimulation treatments.

    6 months

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Hawaii Cataract Laser Institute - Hilo

Hilo, Hawaii, 96720, United States

Location

Retina Institute of Hawaii

Honolulu, Hawaii, 96815, United States

Location

Hawaii Cataract Laser Institute - Maui

Kahului, Hawaii, 96732, United States

Location

Hawaii Cataract Laser Institute - Kona

Kailua-Kona, Hawaii, 96740, United States

Location

MeSH Terms

Conditions

Retinal DiseasesStargardt DiseaseRetinitis Pigmentosa

Condition Hierarchy (Ancestors)

Eye DiseasesEye Diseases, HereditaryMacular DegenerationRetinal DegenerationGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesRetinal Dystrophies

Study Officials

  • George Papastergiou, MD

    Retina Institute of Hawaii

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 11, 2013

First Posted

February 13, 2013

Study Start

June 1, 2012

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

February 13, 2013

Record last verified: 2013-02

Locations

US(4)