The Natural History of Graft-Versus-Host Disease in the Eyes
|ClinicalTrials.gov Identifier: NCT01369914|
Recruitment Status : Completed
First Posted : June 9, 2011
Last Update Posted : April 6, 2018
|First Submitted Date||June 8, 2011|
|First Posted Date||June 9, 2011|
|Last Update Posted Date||April 6, 2018|
|Study Start Date||May 20, 2011|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures
||The primary objective variable is ocular surface staining using fluorescein and lissamine green dyes. The primary subjective outcome measure is the OSDI [ Time Frame: Ongoing ]|
|Original Primary Outcome Measures||Not Provided|
|Change History||Complete list of historical versions of study NCT01369914 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures
|Original Secondary Outcome Measures||Not Provided|
|Current Other Outcome Measures||Not Provided|
|Original Other Outcome Measures||Not Provided|
|Brief Title||The Natural History of Graft-Versus-Host Disease in the Eyes|
|Official Title||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 Design||Observational Model: Case-Control
Time Perspective: Prospective
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Study Groups/Cohorts||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Original Estimated Enrollment
|Study Completion Date||February 5, 2016|
|Primary Completion Date||Not Provided|
|Ages||18 Years and older (Adult, Senior)|
|Accepts Healthy Volunteers||No|
|Contacts||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries||United States|
|Removed Location Countries|
|Other Study ID Numbers||110173
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||National Institutes of Health Clinical Center (CC) ( National Eye Institute (NEI) )|
|Study Sponsor||National Eye Institute (NEI)|
|PRS Account||National Institutes of Health Clinical Center (CC)|
|Verification Date||February 5, 2016|