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The Natural History of Ocular Graft-Versus Host Disease

18 Years
Open (Enrolling)
Graft-Versus-Host Disease

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Trial Information

The Natural History of Ocular Graft-Versus Host Disease


The study objectives are to study the development of ocular graft-versus-host disease (GVHD)
in participants treated with stem cell transplantation (SCT) at the NIH, including exam
findings prior to SCT, changes in ocular signs and symptoms following SCT and response to
standard therapy in participants identified with dry eye and ocular GVHD; to develop
clinical outcome measures for early onset and more advanced ocular GVHD and provide
estimates of progression rates for these outcomes; to analyze tear fluid, impression
cytology (IC) and serum samples from participants undergoing SCT, to identify biomarkers or
other findings which may predict the onset of ocular GVHD or correlate with disease
progression or response to therapy and to establish a cohort of participants with ocular
GVHD in anticipation of future clinical trials.


Up to 50 adult participants undergoing SCT at the NIH will be enrolled.


This prospective, natural history study will follow participants through 12 months post-SC,
with the option to extend follow-up for up to five years.


The primary objective outcome variable is ocular surface staining using fluorescein and
lissamine green dyes, as measured by the Oxford criteria, with the scale ranging from 0 to
15 in each eye. The primary subjective outcome measure is the Ocular Surface Disease Index
(OSDI), ranging from 0 to 100. Secondary outcome variables include best-corrected visual
acuity (BCVA), tear film osmolarity, Schirmer's tear testing with anesthesia, meibomian
gland function and tear break-up time. In addition, tear fluid biomarkers and/or IC will be
studied as secondary outcome variables to determine whether changes in biomarker levels
(tear fluid) or cell densities and morphologies (IC) correlate with the development or
progression of ocular GVHD.

Inclusion Criteria


1. Participant must be 18 years of age or older.

2. Participant must understand and sign the protocol's informed consent document.

3. Participant is scheduled for a SCT under another NIH protocol within the next 30

4. Participant is willing and able to comply with the study procedures and
follow-up visits.


1. Participant has a history of ocular problems which could interfere with the natural
history of their response to treatment with SCT. Examples include significant dry eye
disease, use of cyclosporine eye drops in the past 30 days and conjunctival scarring
for any reason.

2. Participant has known allergies to dilating or anesthetic eye drops.

Type of Study:


Study Design:

Time Perspective: Prospective

Outcome Measure:

The primary objective variable is ocular surface staining using fluorescein and lissamine green dyes. The primary subjective outcome measure is the OSDI

Principal Investigator

Rachel J Bishop, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Eye Institute (NEI)


United States: Federal Government

Study ID:




Start Date:

May 2011

Completion Date:

Related Keywords:

  • Graft-Versus-Host Disease
  • Graft-Versus-Host Disease
  • Natural History Study
  • Hematopoietic Stem Cell Transplant
  • GVHD
  • Graft vs Host Disease



National Institutes of Health Clinical Center, 9000 Rockville Pike Bethesda, Maryland  20892