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Electrostimulation Study for Ocular Graft vs. Host Disease
Electrostimulation Study for Ocular Graft vs. Host Disease

NCT07166848

Enrolling By InvitationNA

Sponsor: Zhonghui K. Luo, MD, PhD

Conditions: Chronic Ocular Graft-versus-host Disease

Interventions: Electrodes with Currents, Electrodes without Currents

Countries: United States

This trial is testing to see if electrostimulation treatment (ET) will be effective in treating those with ocular Graft vs. Host Disease.

Eligibility overview

Sex: ALL

Age: 18 Years to 75 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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
Locations (1)
  • Boston, Massachusetts, United States