Chronic Ocular Graft-versus-host DiseaseNCT07166848
Electrostimulation Study for Ocular Graft vs. Host Disease
A study testing Electrodes with Currents and Electrodes without Currents in people with Chronic Ocular Graft-versus-host Disease, run by Zhonghui K. Luo, MD, PhD at 1 site in United States.
Trial summary
This trial is testing to see if electrostimulation treatment (ET) will be effective in treating those with ocular Graft vs. Host Disease. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Ocular Graft-versus-host Disease
- What is being tested?
- Electrodes with Currents and Electrodes without Currents
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Nov 2025to 30 Nov 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Massachusetts Eye and Ear - Longwood Campus
Boston, Massachusetts, 02215
About this study
Official title: Pilot Trial of Non-invasive Electrostimulation in Chronic Ocular Graft-vs-Host Disease
This trial is testing to see if electrostimulation treatment (ET) will be effective in treating those with ocular Graft vs. Host Disease.
Read the 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.
- Conditions
- Chronic Ocular Graft-versus-host Disease
- Being tested
- Electrodes with Currents, Electrodes without Currents
- Keywords
- GVHD, Electrostimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrodes with CurrentsDevice
Also called Treatment
Electrodes will be placed on the cheeks and forehead, and treated with an amplitude of 300 µA for 30 mins
Electrodes without CurrentsDevice
Also called Sham
Electrodes will be placed on the cheeks and forehead, and treated with an no amplitude for 30 mins
| Study group | Role | What they receive |
|---|---|---|
| Electrostimulation | Experimental | The experimental group will entail the subject wearing the electrodes on the cheeks and forehead, for 30 minutes WITH amplitude. Receives: Device: Electrodes with Currents |
| Sham | Sham comparator | The placebo group will entail the subject wearing the electrodes on the cheeks and forehead, for 30 minutes WITHOUT amplitude. Receives: Device: Electrodes without Currents |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of Electrostimulation (ES) Treatment.
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.
Measured: 8 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2025
- Study start30 Nov 2025
- Primary completion30 Nov 2028 (estimated)
- Study completion30 Nov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Ocular Graft-versus-host DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhonghui K. Luo, MD, PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zhonghui K. Luo, MD, PhD, Massachusetts Eye and Ear Infirmary
- Investigators
- Zhonghui Luo, MD, PhD, Principal investigator, Massachusetts Eye and Ear Infirmary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07166848
- Sponsor's protocol ID
- 2025P002105
- Status last verified
- Aug 2026
- First submitted
- 20 Aug 2025
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Trial of Non-invasive Electrostimulation in Chronic Ocular Graft-vs-Host Disease
- ClinicalTrials.gov ID
- NCT07166848
- Acronym / sponsor ID
- 2025P002105
- Conditions
- Chronic Ocular Graft-versus-host Disease
- Keywords
- GVHD, Electrostimulation
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Zhonghui K. Luo, MD, PhDUniversity, hospital or other
- Study start
- 30 Nov 2025 (actual)
- Primary completion
- 30 Nov 2028 (estimated)
- Study completion
- 30 Nov 2029 (estimated)
- First posted
- 10 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Electrostimulation | Experimental | Device: Electrodes with CurrentsThe experimental group will entail the subject wearing the electrodes on the cheeks and forehead, for 30 minutes WITH amplitude. |
| Sham | Sham comparator | Device: Electrodes without CurrentsThe placebo group will entail the subject wearing the electrodes on the cheeks and forehead, for 30 minutes WITHOUT amplitude. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electrodes with CurrentsAlso: TreatmentElectrodes will be placed on the cheeks and forehead, and treated with an amplitude of 300 µA for 30 mins | Device | Electrostimulation |
| Electrodes without CurrentsAlso: ShamElectrodes will be placed on the cheeks and forehead, and treated with an no amplitude for 30 mins | Device | Sham |
Primary outcome
Efficacy of Electrostimulation (ES) Treatment.
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Zhonghui Luo, MD, PhD principal investigator
Massachusetts Eye and Ear Infirmary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electrodes with Currents and Electrodes without Currents in people with Chronic Ocular Graft-versus-host Disease, run by Zhonghui K. Luo, MD, PhD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of Electrostimulation (ES) Treatment. (time frame: 8 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2026.