Chronic Ocular Graft-versus-host Disease
Conditions
Keywords
GVHD, Electrostimulation
Brief 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.
Interventions
DEVICEElectrodes with Currents
Electrodes will be placed on the cheeks and forehead, and treated with an amplitude of 300 µA for 30 mins
DEVICEElectrodes without Currents
Electrodes will be placed on the cheeks and forehead, and treated with an no amplitude for 30 mins
Sponsors
Zhonghui K. Luo, MD, PhD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
The principal investigator and the participants will be masked to treatment. The study staff setting up the device will be the only staff who will know the randomization.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of Electrostimulation (ES) Treatment. | 8 Weeks | To evaluate whether the use of electrostimulation (ES) over a course of 10 treatments (in 8 weeks) will ameliorate symptoms and signs of chronic ocular Graft-vs-Host Disease (oGVHD) and the effect on sub-basal corneal nerve regeneration. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORZhonghui Luo, MD, PhD
Massachusetts Eye and Ear Infirmary
Outcome results
None listed