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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 Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Supportive Care
Conditions Anterior Uveitis
Iritis
Interventions Device: PEMF
Device: PEMF Placebo
Enrollment 18
Recruitment Details Analysis in process as of December, 2016.
Pre-assignment Details Analysis in process as of December, 2016.
Arm/Group Title Active Device Placebo Device
Hide Arm/Group Description

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.

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.

Analysis in process as of December, 2016.

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.

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.

Analysis in process as of December, 2016.

Period Title: Overall Study
Started 9 9
Completed 9 8
Not Completed 0 1
Reason Not Completed
Lost to Follow-up             0             1
Arm/Group Title Active Device Placebo Device Total
Hide Arm/Group Description

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.

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.

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.

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.

Total of all reporting groups
Overall Number of Baseline Participants 9 9 18
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 9 participants 9 participants 18 participants
42.33  (12.808) 40.22  (14.228) 41.275  (13.576)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 9 participants 18 participants
Female
3
  33.3%
3
  33.3%
6
  33.3%
Male
6
  66.7%
6
  66.7%
12
  66.7%
1.Primary Outcome
Title Inflammation Grade at Day 7
Hide Description 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.
Time Frame 7 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Active Device Placebo Device
Hide Arm/Group Description:

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.

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.

Analysis in process as of December, 2016.

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.

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.

Analysis in process as of December, 2016.

Overall Number of Participants Analyzed 9 8
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.625  (0.876) 1.444  (1.130)
Time Frame 7 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Active Device Placebo Device
Hide Arm/Group Description

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.

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.

Analysis on-going as of December, 2016.

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.

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.

Analysis on-going as of December, 2016.

All-Cause Mortality
Active Device Placebo Device
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Active Device Placebo Device
Affected / at Risk (%) Affected / at Risk (%)
Total   0/9 (0.00%)   0/9 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Active Device Placebo Device
Affected / at Risk (%) Affected / at Risk (%)
Total   0/9 (0.00%)   0/9 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Director of the Ocular Immunology and Uveitis Service
Organization: Massachusetts Eye and Ear Infirmary
Phone: 617-573-5549
EMail: George_Papaliodis@meei.harvard.edu
Layout table for additonal information
Responsible Party: George Papaliodis, Massachusetts Eye and Ear Infirmary
ClinicalTrials.gov Identifier: NCT01154010     History of Changes
Other Study ID Numbers: 09-03-020
First Submitted: June 29, 2010
First Posted: June 30, 2010
Results First Submitted: March 24, 2017
Results First Posted: May 4, 2017
Last Update Posted: February 28, 2018