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PEMF: an Adjunct Therapy for Anterior Uveitis (PEMF)

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ClinicalTrials.gov Identifier: NCT01154010
Recruitment Status : Completed
First Posted : June 30, 2010
Results First Posted : May 4, 2017
Last Update Posted : February 28, 2018
Sponsor:
Collaborator:
BioElectronics Corporation
Information provided by (Responsible Party):
George Papaliodis, Massachusetts Eye and Ear Infirmary

Study Description
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Brief Summary:
The purpose of this study is to determine if a medical device (ActiPatch) that emits a low frequency pulsed electromagnetic field (PEMF) will benefit patients with anterior uveitis. Anterior uveitis (aka iritis) is an inflammatory disease involving the front segment of the eye. This is a common cause of a painful red eye, and ActiPatch has been shown to be effective in treating tissue inflammation. The conventional treatment of iritis typically involves frequent administration of topical steroids which have their own inherent risks (development of cataracts and/or glaucoma). The purpose of this study is to determine if ActiPatch therapy can be used to shorten the length of time and/or quantity of steroids administered.

Condition or disease Intervention/treatment Phase
Anterior Uveitis Iritis Device: PEMF Device: PEMF Placebo Not Applicable

Detailed Description:

Iritis is an inflammatory disease focused in the anterior chamber of the eye. The inflammation inside the eye can lead to a number of conditions that ultimately effect vision. These can include glaucoma, posterior synechiae, cystoid macular edema, and cataract. The standard treatment for the disease is drug therapy centered around the administration of corticosteroids. These are administered in the form of eye drops, and if necessary periocular/intraocular injections, or/and by systemic oral/IV administration. Unfortunately, the treatment with corticosteroids can similarly induce severe side effects including glaucoma and cataract formation. ActiPatch is a medical device that emits a low frequency pulsed electromagnetic field. This device has been shown to reduce inflammation and pain in a number of conditions, eg blepharoplasty (eyelid surgery). ActiPatch is FDA approved for use after blepharoplasty to reduce swelling, inflammation and pain. The treatment is not invasive, does not require additional medication, and side effects from ActiPatch and other PEMF devices have not been reported. The potential benefit of treating uveitis with ActiPatch is the potential to reduce the time and/or amount of steroid administration. This would benefit patients by reducing the risk of unwanted side effects of the corticosteroid treatment.

The benefit to society would be an improved treatment for anterior uveitis.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: PEMF an Adjunct Therapy for Anterior Uveitis
Study Start Date : August 2009
Actual Primary Completion Date : April 2015
Actual Study Completion Date : April 2015

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Active Device
ActiPatch, a device that emits a low frequency energy called "pulsed electromagnetic field" (PEMF), will be worn by patients over the eye with anterior uveitis for 8 hours/day for 7 days. Patients will also be treated with topical steroids.
 Device: PEMF
ActiPatch will be worn by patients over the eye with anterior uveitis for 8 hours/day for 7 days. Patients will also be treated with topical steroids.
Placebo Comparator: Placebo Device
Patients wear the PEMF placebo device for 8 hours/day for 7 days over the eye being treated for anterior uveitis. Patients will also be treated with topical steroids.
 Device: PEMF Placebo
Patients wear the placebo device for 8 hours/day for 7 days over the eye being treated for anterior uveitis. Patients will also be treated with topical steroids.


Outcome Measures
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Primary Outcome Measures :
  1. Inflammation Grade at Day 7 [ Time Frame: 7 days ]
    Degree and grade of ocular inflammation based on Standard Uveitis Nomenclature will be assessed at initial visit, Day 3, and Day 7 of use of the PEMF device to assess if the PEMF device decreases the duration and severity of ocular inflammation when used as an adjunctive therapy for anterior uveitis. The results posted here are from day 7. The Standard Uveitis Nomenclature scale ranges from 0 to 4, with 0 indicating a minimal level of ocular inflammation and 4 indicating the maximal level of corneal inflammation.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Human subjects who have been clinically diagnosed with anterior uveitis (iritis) but are in otherwise in good health will be recruited for the study. The age requirement will be a minimum of 18 yrs. We will recruit 24 patient for this study. Subjects will only be included who have been clinically diagnosed with anterior uveitis (noninfectious). Eligibility will be determined by the treating Ophthalmologist (principal investigator) for inclusion in the study.

Exclusion Criteria:

  • Vulnerable subjects, as defined by the Institutional Review Board (IRB), will not be recruited for participation (This includes individuals under 18, pregnant women, prisoners, fetuses, patients mentally or physically unable to provide written informed consent).
  • Other groups excluded include: patients with pacemakers and patients with ferromagnetic metal implants since these devices may be effected by the pulsed electromagnetic field.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01154010


Locations
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United States, Massachusetts
Massachusetts Eye and Ear Infirmary
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts Eye and Ear Infirmary
BioElectronics Corporation
Investigators
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Principal Investigator: George Papaliodis, MD Massachusetts Eye and Ear Infirmary
More Information
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Publications:

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Responsible Party: George Papaliodis, Director, Ocular Immunology and Uveitis Service, Massachusetts Eye and Ear Infirmary
ClinicalTrials.gov Identifier: NCT01154010    
Other Study ID Numbers: 09-03-020
First Posted: June 30, 2010    Key Record Dates
Results First Posted: May 4, 2017
Last Update Posted: February 28, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: A forthcoming article will include a chart that will document individual participant data.
Keywords provided by George Papaliodis, Massachusetts Eye and Ear Infirmary:
PEMF
iritis
anterior uveitis
Additional relevant MeSH terms:
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Uveitis
Uveitis, Anterior
Iridocyclitis
Iritis
 Uveal Diseases
Eye Diseases
Panuveitis
Iris Diseases