PEMF: an Adjunct Therapy for Anterior Uveitis

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Massachusetts Eye and Ear Infirmary
Sponsor:
Collaborator:
BioElectronics Corporation
Information provided by (Responsible Party):
Ann-Marie Lobo, MD, Massachusetts Eye and Ear Infirmary
ClinicalTrials.gov Identifier:
NCT01154010
First received: June 29, 2010
Last updated: April 4, 2014
Last verified: April 2014
  Purpose

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 Intervention
Anterior Uveitis
Iritis
Device: PEMF
Device: PEMF Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: PEMF an Adjunct Therapy for Anterior Uveitis

Resource links provided by NLM:


Further study details as provided by Massachusetts Eye and Ear Infirmary:

Primary Outcome Measures:
  • Inflammation grade [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Redness and pain scale [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    Patients will be asked to rate their pain and redness daily from the initial visit until the end of the study and use of the PEMF device at Day 7. This data will allow us to assess if subjectively, patients report improvement in pain with the active Actipatch devices compared to placebo devices when used with standard therapy for anterior uveitis.


Estimated Enrollment: 24
Study Start Date: August 2009
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Active Device 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 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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
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
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: NCT01154010

Contacts
Contact: George Papaliodis, MD 617-573-5549 George_Papaliodis@meei.harvard.edu
Contact: Ann-Marie Lobo, MD 617-573-5549 Ann-Marie_Lobo@meei.harvard.edu

Locations
United States, Massachusetts
Massachusetts Eye and Ear Infirmary Recruiting
Boston, Massachusetts, United States, 02114
Principal Investigator: George Papaliodis, MD         
Sub-Investigator: Ann-Marie Lobo, MD         
Sponsors and Collaborators
Massachusetts Eye and Ear Infirmary
BioElectronics Corporation
Investigators
Principal Investigator: George Papaliodis, MD Massachusetts Eye and Ear Infirmary
  More Information

Publications:
Responsible Party: Ann-Marie Lobo, MD, MEEI - Staff Ophthalmologist, Massachusetts Eye and Ear Infirmary
ClinicalTrials.gov Identifier: NCT01154010     History of Changes
Other Study ID Numbers: 09-03-020
Study First Received: June 29, 2010
Last Updated: April 4, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts Eye and Ear Infirmary:
PEMF
iritis
anterior uveitis

Additional relevant MeSH terms:
Chorioretinitis
Iridocyclitis
Uveitis
Uveitis, Anterior
Choroid Diseases
Choroiditis
Eye Diseases
Iris Diseases
Panuveitis
Retinal Diseases
Retinitis
Uveal Diseases
Uveitis, Posterior

ClinicalTrials.gov processed this record on October 23, 2014