PEMF: an Adjunct Therapy for Anterior Uveitis
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.
|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|
- 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.
- 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.
|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)|
|Active Comparator: Active Device||
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01154010
|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|
|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|
|Principal Investigator:||George Papaliodis, MD||Massachusetts Eye and Ear Infirmary|