N/A
N=18
PEMF: an Adjunct Therapy for Anterior Uveitis
Anterior Uveitis · Iritis
Bottom Line
View on ClinicalTrials.gov: NCT01154010 ↗Enrolled (actual)
18
Serious AEs
0.0%
Results posted
May 2017
Primary outcome: Primary: Inflammation Grade at Day 7 — 0.625; 1.444 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- PEMF (Device); PEMF Placebo (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Massachusetts Eye and Ear Infirmary
- Primary completion
- Apr 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Inflammation Grade at Day 7 |
0.625; 1.444 | — |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT01154010). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.