NCT07166848NARecruiting
Electrostimulation Study for Ocular Graft vs. Host Disease
Zhonghui K. Luo, MD, PhD
Start Date
11/30/2025
Completion Date
11/30/2029
Summary
This trial is testing to see if electrostimulation treatment (ET) will be effective in treating those with ocular Graft vs. Host Disease.
Detailed Description
The trial is to test whether transcutaneous electrical stimulation (TES) may be an effective new type of non-invasive treatment for patients who are diagnosed with chronic ocular Graft-vs-Host Disease. Such a treatment can potentially decrease the need for the patients to apply eye drops frequently, repair the damage caused by chronic ocular Graft-vs-Host Disease, and improve the comfort of the eyes naturally.
Eligibility Criteria
Age Range: 18 years to 75 years
Inclusion Criteria:
* Diagnosis of chronic ocular graft vs. host disease (oGVHD) (ICCGVHD criteria probable or definite)
* OSDI score of 22 or higher
* NEI corneal staining score (or modified NEI score) of 2 or higher.
Exclusion Criteria:
* Patients with any open wound on the eyelid.
* Patient with any active cornea ulcer, dacryocystitis, hordeolum, filamentary keratitis, uveitis, retinal detachment, uncontrolled glaucoma or other active pathology per PI's discretion.
* Patient with a pacemaker or ICD.
* Patient currently pregnant or with a potential to be pregnant during the study.
* Patient undergoing any ocular surgical procedure (including intravitreal injections) within the past 3 months.
* Patient undergoing any systemic surgical procedures within 2 months.
* Patient undergoing any non-surgical eyelid procedure such as punctal plugs or punctal cautery within 1 month of study initiation.
* Patients on cytotoxic agents, drugs that inhibit peripheral nerve regeneration (i.e. Gabapentin, Nicotine), radiation therapy, or any other therapy per PI's discretion.
* Patients undergoing immunosuppression regimen change within 1 month of study initiation and/or during the study period.
* Patient who wears contact lens of any kind
Interventions
DEVICE
Electrodes with Currents
DEVICE
Electrodes without Currents
Conditions
Chronic Ocular Graft-versus-host Disease
Locations
Massachusetts Eye and Ear - Longwood Campus
Boston, Massachusetts 02215
United States