Ocular Surface Immune Response in Dry Eye Disease

Ocular Surface Immune Response in Dry Eye Disease: Analysis of Conjunctival and Peripheral Corneal Immune Cell Alterations by In Vivo Confocal Microscopy and Clinical Correlation

In vivo confocal microscopy (IVCM) is a sensitive imaging tool for detecting dry eye-associated subclinical inflammation. Studies have previously shown that IVCM provides an in vivo metric to measure inflammatory changes in the central cornea. The objective of the current study is to assess inflammatory response changes in the peripheral cornea and the conjunctiva by analyzing epithelial immune cell density and morphology in these areas and then correlating the IVCM findings to clinical signs and symptoms to establish novel objective imaging biomarkers.

Study Overview

• Status: Completed
• Conditions: Dry Eye Disease
• Intervention / Treatment: Other: In vivo confocal microscopy (IVCM)

• Study Type: Observational
• Enrollment (Actual): 67

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts Eye and Ear Infirmary

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with and without Dry Eye Disease

Description

For Dry Eye Disease Participants

Inclusion Criteria:

• Age >18
• Ability to consent to study
• Symptoms of dry eye disease for at least 6 months, such foreign body sensation, burning, stinging, light sensitivity
• Positive vital dye staining of the cornea
• At least one of the following objective signs: (Schirmer I <10 mm at 5 minutes), decreased (<0.2 mm) tear meniscus, decreased tear breakup time (TBUT) of <10 seconds, positive vital dye staining of the conjunctiva

For Age-Match Controls

Inclusion Criteria:

• Between the ages of 18-89
• The ability to provide informed consent for study inclusion
• Clear, healthy cornea
• Normal tear meniscus (> 0.3 mm)

For Dry Eye Disease Participants

Exclusion Criteria:

• History of contact lens wear in the past 3 months
• History of ocular surgery in the past 6 months
• Active ocular allergies
• History of ocular infection in the past 3 months
• History of diabetes
• History of topical or systemic anti-inflammatory therapy in the past 1 month

For Age-Match Controls

Exclusion Criteria:

• History of ocular or eyelid surgery within the past 12 months
• History of herpetic or other infectious keratitis or other inflammatory eye disease
• History of any other acute ocular disease
• Current use of topical medications (not including artificial tears)
• Current use of contact lenses
• History of ocular carcinoma or any recent ocular topical chemotherapy or radiotherapy
• History of cancer elsewhere in the body which is currently under systemic chemotherapy
• Current glaucoma disease requiring use of glaucoma drops
• History of Diabetes mellitus
• Current diagnosis of dry eye disease

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Dry Eye Disease; Confocal Imaging - In vivo confocal microscopy (IVCM) Ophthalmic Examination: Tear Break Up Time (TBUT); Ocular Surface Disease Index (OSDI); Schirmer's II test; Conjunctival staining with lissamine green; Corneal staining with fluorescein; Conjunctival redness assessment	Other: In vivo confocal microscopy (IVCM); IVCM is a sensitive tool for detecting dry eye-associated subclinical inflammation.
Control; Confocal Imaging - In vivo confocal microscopy (IVCM) Ophthalmic Examination: TBUT; OSDI; Schirmer's II test; Conjunctival staining with lissamine green; Corneal staining with fluorescein; Conjunctival redness assessment	Other: In vivo confocal microscopy (IVCM); IVCM is a sensitive tool for detecting dry eye-associated subclinical inflammation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peripheral Corneal Immune cell Status by IVCM	Peripheral Corneal Immune cell Status by IVCM • Density of dendritic immune cells • Density of non-dendritic immune cells • Morphology of immune cells	Visit 1
Bulbar conjunctival immune cell Status by IVCM	Bulbar conjunctival immune cell Status by IVCM • Density of dendritic immune cells • Density of non-dendritic immune cells • Morphology of immune cells	Visit 1

Secondary Outcome Measures

Outcome Measure	Time Frame
Clinical Parameter: Ocular Surface Disease Index (OSDI)	Visit 1
Clinical Parameter: Schirmer's II test	Visit 1
Clinical Parameter: Conjunctival staining with lissamine green	Visit 1
Clinical Parameter: Corneal staining with fluorescein	Visit 1
Clinical Parameter: Tear Break Up Time (TBUT)	Visit 1
Clinical Parameter: Conjunctival redness	Visit 1

Collaborators and Investigators

• Sponsor: Tufts Medical Center
• Investigators: Principal Investigator: Pedram Hamrah, MD, MEEI

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Actual): July 1, 2015
• Study Completion (Actual): July 1, 2015

Study Registration Dates

• First Submitted: January 17, 2014
• First Submitted That Met QC Criteria: January 20, 2014
• First Posted (Estimate): January 23, 2014

Study Record Updates

• Last Update Posted (Actual): October 18, 2017
• Last Update Submitted That Met QC Criteria: October 16, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: Dry Eye
• Additional Relevant MeSH Terms: Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Eye Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca
• Other Study ID Numbers: 13-149H