The Natural History of Graft-Versus-Host Disease in the Eyes
|First Received Date ICMJE||June 8, 2011|
|Last Updated Date||September 5, 2014|
|Start Date ICMJE||May 2011|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||The primary objective variable is ocular surface staining using fluorescein and lissamine green dyes. The primary subjective outcome measure is the OSDI|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT01369914 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
||Secondary outcome variables include changes in BCVA (ETDRS); tear film osmolarity; Schirmer's testing with anesthesia; meibomain gland function; tear break-up time.|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||The Natural History of Graft-Versus-Host Disease in the Eyes|
|Official Title ICMJE||The Natural History of Ocular Graft-Versus Host Disease|
- To learn more about graft-versus-host disease (GVHD) of the eyes in people who have had stem cell transplantation.
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, and up to 50 healthy adult participants 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.
|Study Type ICMJE||Observational|
|Study Design ICMJE||Time Perspective: Prospective|
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Condition ICMJE||Graft-Versus-Host Disease|
|Intervention ICMJE||Not Provided|
|Study Group/Cohort (s)||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Recruiting|
|Estimated Enrollment ICMJE||100|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||18 Years and older|
|Accepts Healthy Volunteers||No|
|Location Countries ICMJE||United States|
|NCT Number ICMJE||NCT01369914|
|Other Study ID Numbers ICMJE||110173, 11-EI-0173|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||National Eye Institute (NEI)|
|Collaborators ICMJE||Not Provided|
|Information Provided By||National Institutes of Health Clinical Center (CC)|
|Verification Date||February 2014|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP