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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
Sponsor:
Collaborator:
Singapore General Hospital
Information provided by (Responsible Party):
Louis Tong, Singapore National Eye Centre

Brief Summary:
This study aims to profile the ocular surface inflammation of chronic Graft-Versus-Host Disease patients by investigating conjunctival cells, and clinical imaging for conjunctival redness and tear stability. Hence, the investigators expect to find an increased in inflammatory cell population in GVHD conjunctival samples.

Condition or disease Intervention/treatment
Dry Eye GVHD Other: Cross-sectional study

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
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





Primary Outcome Measures :
  1. Dry Eye Symptoms (SPEED Questionnaire) [ Time Frame: Baseline ]

Secondary Outcome Measures :
  1. Non-invasive Tear Break-up Time (NIKBUT) [ Time Frame: Baseline ]
  2. 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.

  3. 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.

  4. Measuring tear biomarker [ Time Frame: Baseline ]
  5. Conjunctival Immune Cell Profile [ Time Frame: Baseline ]
    Proportions of T lymphocytes and other immune cells

  6. 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.



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Ages Eligible for Study:   21 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

This is a cross-sectional study involving 30 consecutive suitable GVHD patients. Suitable patients will be identified by haematologists from the SGH transplantation Centre (Block 7, level 1).

Study duration: One visit

Recruitment duration: 1 Year

Criteria

Inclusion Criteria:

1. Clinically diagnosed with chronic Graft Versus Host Disease (GVHD).

Exclusion Criteria:

  1. No ocular surgery within the last 3 months and LASIK within 1 year.
  2. Ocular surface diseases such as pterygium, or obvious lid/orbital disease with lagophthalmos.
  3. Any other specified reason as determined by clinical investigator.

Information from the National Library of Medicine

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


Contacts
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Contact: Louis Tong, PhD louis.tong.h.t@singhealth.com.sg

Locations
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Singapore
Cynthia Boo Recruiting
Singapore, Singapore, 168751
Contact: Cynthia Boo, Bsc    98206648    cynthia.boo.s.k@seri.com.sg   
Sponsors and Collaborators
Singapore National Eye Centre
Singapore General Hospital

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Responsible Party: Louis Tong, Principal Investigator, Singapore National Eye Centre
ClinicalTrials.gov Identifier: NCT02712762     History of Changes
Other Study ID Numbers: R1312/118/2015
2016/2085 ( Registry Identifier: SingHealth CIRB )
First Posted: March 18, 2016    Key Record Dates
Last Update Posted: September 27, 2019
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Louis Tong, Singapore National Eye Centre:
immunological profiles
Additional relevant MeSH terms:
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Keratoconjunctivitis Sicca
Dry Eye Syndromes
Graft vs Host Disease
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases
Immune System Diseases