Ocular Surface Disease in Chronic Graft-Versus-Host Disease (GVHD) Patients
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|ClinicalTrials.gov Identifier: NCT02712762|
Recruitment Status : Recruiting
First Posted : March 18, 2016
Last Update Posted : September 27, 2019
|Condition or disease||Intervention/treatment|
|Dry Eye GVHD||Other: Cross-sectional study|
|Study Type :||Observational|
|Estimated Enrollment :||30 participants|
|Official Title:||Dry Eye and Ocular Surface Disease in Chronic Graft-Versus-Host Disease (GVHD) Patients|
|Study Start Date :||June 2016|
|Estimated Primary Completion Date :||November 2020|
|Estimated Study Completion Date :||November 2020|
- Dry Eye Symptoms (SPEED Questionnaire) [ Time Frame: Baseline ]
- Non-invasive Tear Break-up Time (NIKBUT) [ Time Frame: Baseline ]
- Imaging of Conjunctival Redness [ Time Frame: Baseline ]These parameters will be imaged and measured by Keratograph 5M. Briefly, the participant will be asked to look at a target in the instrument while blinking normally. The keratographer will scan the ocular surface and images will be captured. The grading of the conjunctival hyperemia will be automatically performed relative to standard pictures of increasing redness stored on the system.
- Tear production with Schirmers I test [ Time Frame: Baseline ]This will be done with the standard Schirmer Tear Test Strips from Clement Clark currently used at SERI (5 mm wide with a notch for folding). No prior anaesthetic will be used. The strips will be positioned over the inferior temporal half of the lower lid margin in both eyes at the same time. Subjects will be asked to close their eyes. Any excessive irritation signs will be noted. The extent of the wetting in each strip will be recorded after 5 minutes of testing. The strip will be collected and stored in 1.5 ml eppendorf tubes at -80˚C until further analysis.
- Measuring tear biomarker [ Time Frame: Baseline ]
- Conjunctival Immune Cell Profile [ Time Frame: Baseline ]Proportions of T lymphocytes and other immune cells
- Corneal Fluorescein Staining Score [ Time Frame: Baseline ]A drop of normal saline will be instilled on the fluorescein strip (Fluorets) then shaken off so that no visible drop remains. The subject is asked to look up before the introduction of the fluoret to the inferior conjunctival fornix on the right then left eye. Corneal fluorescein staining will be imaged by Keratograph 5M. Scoring system will be based on CCLRU. Briefly, there will be 5 corneal zones. The staining scale is 0-4, with 0.5 unit steps in each of the zones.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02712762
|Contact: Louis Tong, PhDfirstname.lastname@example.org|
|Singapore, Singapore, 168751|
|Contact: Cynthia Boo, Bsc 98206648 email@example.com|