Exploring Immune Cell Signatures in Autoimmunity and Dry Eye Syndrome

NCT02715323 | Completed

• 2 other identifiers: R1295/101/2015 (SERI-STIIC-3)2016/2048
• Study Type: observational
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Autoimmunity; Dry Eye Syndrome

Keywords

dry eye; immunological profile; autoimmune

Outcome Measures

Primary Outcomes (1)

• Dry Eye Symptoms (SPEED Questionnaire)

  Day 0

Secondary Outcomes (6)

• Non-invasive Tear Break-up Time (NIKBUT)

  Day 0

• Conjunctival Redness Grading with Oculus Keratograph 5M

  Day 0

• Tear collection from Schirmers strip

  Day 0

• To profile immune cells with EyePRIM membrane

  Day 0

• Documenting Corneal Fluorescein Staining

  Day 0

Interventions

Cross-sectional study OTHER

Eligibility Criteria

• Age: 21 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

We will recruit patients with 3 specific rheumatological diagnoses and controls * SS (n=40), RA (n=40), SLE (n=40) * Healthy age/ethnicity/sex matched control subjects (n=40) Total sample size: 160

You may qualify if:

• \. Clinically diagnosed with Primary Sjogren's Syndrome, Rheumatoid Arthritis or Systemic Lupus Erythematosus.
• NO Dry eye or severe Meibomian Gland Disease
• NO current or recent (\< 6 months) conjunctivitis, keratitis, uveitis or other inflammatory condition affecting eye
• NO recent ocular surgery or LASIK (\< 6 months)
• Frequency of dry eye symptoms is \< once/week (burning, tearing, itching, foreign body sensation, transient blurring improved by blinking)
• NO contact lens wear for the past 1 week
• NO systemic conditions of Diabetes Mellitus, Rheumatoid Arthritis, Systemic Lupus Erythematosus
• Bulbar redness is \< 1.5 grading

You may not qualify if:

• Known history of thyroid disorders (diagnosed by physician)
• No ocular surgery within the last 3 months and LASIK within 1 year.
• Ocular surface diseases such as pterygium, or obvious lid/orbital disease with lagophthalmos.
• Any other specified reason as determined by clinical investigator.

Sponsors & Collaborators

• Singapore National Eye Centre: lead
• SingHealth Translational Immunology and Inflammation Centre: collaborator
• TTSH Eye Clinic: collaborator

Study Sites (1)

Cynthia Boo

Singapore, 168751, Singapore

Location

MeSH Terms

Conditions

Autoimmune Diseases; Dry Eye Syndromes

Interventions

Cross-Sectional Studies

Condition Hierarchy (Ancestors)

Immune System Diseases; Lacrimal Apparatus Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Studies; Epidemiologic Study Characteristics; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 8, 2016
• First Posted: March 22, 2016
• Study Start: May 1, 2016
• Primary Completion: November 1, 2019
• Study Completion: November 1, 2019
• Last Updated: April 17, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)