Ocular GVHDNCT04700657
The Prevalence of Hypoesthesia Related Keratitis in Ocular Graft Vs. Host Disease (GVHD) Patients
An observational study of Ocular GVHD, run by Indiana University at 1 site in United States.
Trial summary
The Investigators hypothesize that the recalcitrant nature of ocular GVHD may be related to corneal nerve damage and corneal hypoesthesia. The investigators aim to study the prevalence of corneal hypoesthesia in GVHD patients and its correlation with ocular surface changes. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ocular GVHD
- What is being tested?
- corneal sensation test
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Dec 2020to Jun 2028
- Phase
- Observational
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 30 eyes from 15 patients affected by ocular GVHD, and 30 healthy control eyes from 15 age-matched normal volunteers.
Who may be able to join
- Chronic GVHD is diagnosed based on the history of allogeneic HSCT (Hematopoietic stem cell transplant) and the presence of systemic GVHD in organs other than the eye. In the ocular GVHD group, dry eye symptoms start after the development of systemic GVHD. If post-HSCT dry eye precedes GVHD clinical signs in other organs, the investigators will use the 2013 diagnostic criteria by International chronic ocular GVHD consensus group.
- The investigators will recruit patients for the study. The investigators plan to include ocular GVHD patients that are of age 18 years or older who have typical symptoms of dry eye with an Ocular Surface Disease Index (OSDI) score greater than 13 and corneal fluorescein staining (CFS) score of 3 or more (National Eye Institute [NEI] grading scale, 0-15). Normal age-matched volunteer group will include people whose OSDI less or equal to 13 and CFS score less than 3.
- The patients will continue their current systemic and ocular medications, which may include one or combination of preservative free artificial tears, restasis or xiidra, serum tears, ointment, or scleral contact lens.
Who cannot join
- patients with a history of herpetic simplex or zoster keratitis, ocular or neurologic surgery (including laser or refractive surgical procedure) within 3 months before enrollment, trauma, diabetes with signs of peripheral neuropathy.
- patients with active corneal thinning or infection.
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, 1 recruiting
- Recruiting
Glick Eye Institute - Indiana University
Indianapolis, Indiana, 46202
Linda Morgan, 317-274-2745, lismorga@iupui.edu
Michele Spriggs, 317-274-2745, mmmcpher@iupui.edu
About this study
Official title: Investigation of the Prevalence of Hypoesthesia Related Neurotrophic Keratitis in Patients With Ocular Graft Versus Host Disease
The Investigators hypothesize that the recalcitrant nature of ocular GVHD may be related to corneal nerve damage and corneal hypoesthesia. The investigators aim to study the prevalence of corneal hypoesthesia in GVHD patients and its correlation with ocular surface changes.
Read the detailed description
Rationale: Graft-versus-host disease(GVHD) is a common complication of allogeneic bone marrow or hematopoietic stem cell transplantation (HSCT). It affects multiple systems, including skin, gastrointestinal system, liver, lung, and oral cavity, as well as eyes, which contributes to decreased quality of life and increased mortality. About 10% of patients with acute GVHD and 60-90% of those with chronic GVHD develop ocular complications. Dry eye is the most common manifestation of ocular GVHD. The pathogenesis remains unclear. The conjunctival tissue and cornea are the main immunological targets in GVHD. Patients often have punctate hypothesize that the recalcitrant nature of ocular GVHD may be related to corneal nerve damage and sensation changes.
There are a few confocal microscopy studies on corneal nerve changes in GVHD, including increased tortuosity and reduced reflectivity of sub-basal nerves. However, there were very few studies on clinical correlations of those microscopic changes with corneal sensation and ocular surface health. In addition, confocal microscopes are not widely available in clinical practice. It also requires the special expertise of technicians and physicians to obtain and explain the images. It is therefore not feasible to routinely perform confocal microscopy for corneal innervation study.
The investigators plan to study the corneal sensation changes and their correlation with ocular surface staining, tear film breakdown and meibomian gland dysfunction in GVHD patients. The study will shed light on an important aspect of corneal innervation damage in GVHD and may lead to new treatment modalities for those patients, noting that topical recombinant human nerve growth factor cenegermin was recently FDA approved for neurotrophic keratopathy. The investigators intend to identify the ocular characteristics of GVHD patients that may potentially benefit from cenegermin treatment.
- Conditions
- Ocular GVHD
- Being tested
- corneal sensation test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
corneal sensation testDiagnostic test
Thorough ocular surface study including corneal sensation test in the GVHD group, comparing to the normal control group
| Study group | Role | What they receive |
|---|---|---|
| 15 patients affected by ocular GVHD | Not described Receives: Diagnostic Test: corneal sensation test | |
| 15 age-matched normal volunteers. | Not described Receives: Diagnostic Test: corneal sensation test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Corneal Hypoesthesia
Corneal Sensation in GVHD compared to healthy age matched controls as measured with Cochet Bonet esthesiometer.
Measured: Baseline clinic visit
Secondary outcomes (1)
dry eye questionnaire, dry eye signs, meibomian gland dysfunction
- correlation between corneal hypoesthesia and OSDI questionaire (scale 0-100 points, where higher is worse symptoms)
- correlation between corneal hypoesthesia and measure of tear break up time (seconds, where less is worse)
- correlation between corneal hypoesthesia and bulbar redness (scale 0-4 where higher is worse)
- correlation between corneal hypoesthesia and tear meniscus height (measured in mm where less than 0.2mm is worse)
- correlation between corneal hypoesthesia and meibomiography using oculus keratograph ( lower is better)
- correlation between corneal hypoesthesia and fluorescein staining at slit lamp (NEI scale 0-15 where higher is worse)
- correlation between corneal hypoesthesia and lissamine green staining (NEI scale 0-8 where higher is worse)
- correlation between corneal hypoesthesia and schirmer test without anesthesia (measured in mm at 5 minutes where fewer mm of wetting is worse)
Measured: Baseline clinic visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2021
- Study start17 Dec 2020
- Primary completionJun 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ocular GVHDStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shaohui Liu, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04700657
- Sponsor's protocol ID
- 2004207079
- Status last verified
- Jul 2026
- First submitted
- 23 Nov 2020
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Prevalence of Hypoesthesia Related Neurotrophic Keratitis in Patients With Ocular Graft Versus Host Disease
- ClinicalTrials.gov ID
- NCT04700657
- Acronym / sponsor ID
- 2004207079
- Conditions
- Ocular GVHD
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- 17 Dec 2020 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 8 Jan 2021 (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.
The Investigators hypothesize that the recalcitrant nature of ocular GVHD may be related to corneal nerve damage and corneal hypoesthesia. The investigators aim to study the prevalence of corneal hypoesthesia in GVHD patients and its correlation with ocular surface changes.
Detailed description
Rationale: Graft-versus-host disease(GVHD) is a common complication of allogeneic bone marrow or hematopoietic stem cell transplantation (HSCT). It affects multiple systems, including skin, gastrointestinal system, liver, lung, and oral cavity, as well as eyes, which contributes to decreased quality of life and increased mortality. About 10% of patients with acute GVHD and 60-90% of those with chronic GVHD develop ocular complications. Dry eye is the most common manifestation of ocular GVHD. The pathogenesis remains unclear. The conjunctival tissue and cornea are the main immunological targets in GVHD. Patients often have punctate hypothesize that the recalcitrant nature of ocular GVHD may be related to corneal nerve damage and sensation changes.
There are a few confocal microscopy studies on corneal nerve changes in GVHD, including increased tortuosity and reduced reflectivity of sub-basal nerves. However, there were very few studies on clinical correlations of those microscopic changes with corneal sensation and ocular surface health. In addition, confocal microscopes are not widely available in clinical practice. It also requires the special expertise of technicians and physicians to obtain and explain the images. It is therefore not feasible to routinely perform confocal microscopy for corneal innervation study.
The investigators plan to study the corneal sensation changes and their correlation with ocular surface staining, tear film breakdown and meibomian gland dysfunction in GVHD patients. The study will shed light on an important aspect of corneal innervation damage in GVHD and may lead to new treatment modalities for those patients, noting that topical recombinant human nerve growth factor cenegermin was recently FDA approved for neurotrophic keratopathy. The investigators intend to identify the ocular characteristics of GVHD patients that may potentially benefit from cenegermin treatment.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 15 patients affected by ocular GVHD | – | Diagnostic Test: corneal sensation test |
| 15 age-matched normal volunteers. | – | Diagnostic Test: corneal sensation test |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 30 eyes from 15 patients affected by ocular GVHD, and 30 healthy control eyes from 15 age-matched normal volunteers.
Key inclusion criteria (3 listed)
- Chronic GVHD is diagnosed based on the history of allogeneic HSCT (Hematopoietic stem cell transplant) and the presence of systemic GVHD in organs other than the eye. In the ocular GVHD group, dry eye symptoms start after the development of systemic GVHD. If post-HSCT dry eye precedes GVHD clinical signs in other organs, the investigators will use the 2013 diagnostic criteria by International chronic ocular GVHD consensus group.
- The investigators will recruit patients for the study. The investigators plan to include ocular GVHD patients that are of age 18 years or older who have typical symptoms of dry eye with an Ocular Surface Disease Index (OSDI) score greater than 13 and corneal fluorescein staining (CFS) score of 3 or more (National Eye Institute [NEI] grading scale, 0-15). Normal age-matched volunteer group will include people whose OSDI less or equal to 13 and CFS score less than 3.
- The patients will continue their current systemic and ocular medications, which may include one or combination of preservative free artificial tears, restasis or xiidra, serum tears, ointment, or scleral contact lens.
Key exclusion criteria (2 listed)
- patients with a history of herpetic simplex or zoster keratitis, ocular or neurologic surgery (including laser or refractive surgical procedure) within 3 months before enrollment, trauma, diabetes with signs of peripheral neuropathy.
- patients with active corneal thinning or infection.
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 |
|---|---|---|
| corneal sensation testThorough ocular surface study including corneal sensation test in the GVHD group, comparing to the normal control group | Diagnostic test | 15 age-matched normal volunteers., 15 patients affected by ocular GVHD |
Primary outcome
Corneal Hypoesthesia
Time frame: Baseline clinic visit
Corneal Sensation in GVHD compared to healthy age matched controls as measured with Cochet Bonet esthesiometer.
1 secondary outcome
dry eye questionnaire, dry eye signs, meibomian gland dysfunction
Time frame: Baseline clinic visit
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 12 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Ocular GVHD
Not yet recruitingPhase 2
Evaluation of Allogenic Mesenchymal Stem Cell (MSC) Injection Therapy for Refractory Graft-versus-Host Disease (GVHD) Unresponsive to Conventional Treatments
Dry Eye Disease (DED), Graft-Versus-Host Disease(GVHD)
RecruitingPhase 3
Study of d-MAPPS™ Ophthalmic Solution in Adults With Chronic Ocular Graft-Versus-Host Disease (oGVHD)
oGVHD, Ocular Graft Versus Host Disease
RecruitingPhase 2
A PHASE II PROSPECTIVE RANDOMIZED DOUBLE-MASKED CROSSOVER STUDY ASSESSING THE SAFETY & EFFICACY OF RHPRG4 (450 μG/ML RECOMBINANT HUMAN PROTEOGLYCAN 4) COMPARED TO VEHICLE FOR THE TREATMENT OF OCULAR GRAFT-VERSUS-HOST DISEASE (OGVHD)
Ocular Graft Versus Host Disease
Active, not recruitingPhase 2
Autologous Serum Obtained by a Closed-Circuit Collection Device
GVHD, Meibomian Gland Dysfunction (Disorder)
RecruitingPhase 3
An Efficacy and Safety Study of Cenegermin Ophthalmic Solution Compared With Vehicle in the Treatment of PCED
Persistent Corneal Epithelial Defect
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ocular GVHD, run by Indiana University 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 2 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: looking for participants now, as of the sponsor's last update on 12 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. 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?
Contact Linda Morgan (317-274-2745, lismorga@iupui.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Corneal Hypoesthesia (time frame: Baseline clinic visit). 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 12 Aug 2026.