Exploring Immune Cell Signatures in Autoimmunity and Dry Eye Syndrome
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|ClinicalTrials.gov Identifier: NCT02715323|
Recruitment Status : Recruiting
First Posted : March 22, 2016
Last Update Posted : May 10, 2019
Ocular surface disease, especially dry eye and scleritis, commonly affects patients with autoimmune diseases. Ocular surface immune cells are increased in autoimmune disease; however the full subset of immune cells activated is unknown. Recent experimental studies show that dendritic cells and T cells in the cornea are critically associated with corneal nerve innervation. Corneal confocal microscopy (CCM) allows rapid non-invasive in vivo imaging of dendritic cells and corneal nerves. The investigators propose to investigate how ocular surface health, conjunctival immune cells and corneal nerve/dendritic cell morphology interact in 3 rheumatological conditions: Sjogren's syndrome (SS), Rheumatoid arthritis (RA), Systemic lupus erythematosus (SLE).
The preliminary flow cytometric studies show that various immune cells (eg: T cells, B cells, and dendritic cells) can be quantified using minimally invasive impression membranes (Eyeprim). Clinically, the research team is experienced in measuring features of ocular surface inflammation (conjunctival redness, tear breakup times) with Oculus keratograph5M. The investigators also aim to harvest conjunctival immune cells using impression cytology and quantify specific cell types with flow cytometry. Corneal nerve morphology and dendritic cell density and distribution will be assessed using CCM; in collaboration with the group who have pioneered this technique.
The investigator anticipate that alterations in corneal nerve and dendritic cell parameters will correlate with immune activation/inflammation, deterioration of tear function and increased systemic severity of the rheumatological disease. In addition, the investigators hypothesize that the lower the corneal nerve density, the higher the number of corneal dendritic cells and conjunctival inflammatory cells. Studying these relationships may allow a better mechanistic understanding of local corneal and systemic immune activation and the development of a non-invasive ophthalmic surrogate marker of dendritic cell activation and nerve fibre loss to aid earlier diagnosis, risk stratification and the development of new therapies in autoimmune patients with severe dry eye.
|Condition or disease||Intervention/treatment|
|Autoimmunity Dry Eye Syndrome||Other: Cross-sectional study|
|Study Type :||Observational|
|Estimated Enrollment :||160 participants|
|Official Title:||Exploring Immune Cell Signatures in Autoimmunity and Ocular Surface Stress|
|Actual Study Start Date :||May 2016|
|Estimated Primary Completion Date :||July 2020|
|Estimated Study Completion Date :||July 2020|
- Dry Eye Symptoms (SPEED Questionnaire) [ Time Frame: Day 0 ]
- Non-invasive Tear Break-up Time (NIKBUT) [ Time Frame: Day 0 ]
- Conjunctival Redness Grading with Oculus Keratograph 5M [ Time Frame: Day 0 ]
- Tear collection from Schirmers strip [ Time Frame: Day 0 ]
- To profile immune cells with EyePRIM membrane [ Time Frame: Day 0 ]Patients will be instilled with 1 drop of local anaesthetic. Conjunctival cells will be collected using EyePrim membrane by applying the membrane on the temporal and nasal conjunctival, the conjunctival cells will then be scrapped off the membrane using a 10ul micropipette tip into the 1.5ml of RPMI solution in a 2ml eppendorf tube. On the same day, FACs analysis will be done on the cells in the lab.
- Documenting Corneal Fluorescein Staining [ Time Frame: Day 0 ]
- Measuring cornea nerve density [ Time Frame: Day 0 ]
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): NCT02715323
|Singapore, Singapore, 168751|
|Contact: Cynthia Boo, BSc 98206648 firstname.lastname@example.org|