Ocular Surface Immune Response in Dry Eye Disease

NCT ID: NCT02042820

Last Updated: 2017-10-18

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 67 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2015-07-31

Brief Summary

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.

Conditions

Dry Eye Disease

Keywords

Dry Eye

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

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

In vivo confocal microscopy (IVCM)

Intervention Type: OTHER

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

In vivo confocal microscopy (IVCM)

Intervention Type: OTHER

IVCM is a sensitive tool for detecting dry eye-associated subclinical inflammation.

Interventions

In vivo confocal microscopy (IVCM)

IVCM is a sensitive tool for detecting dry eye-associated subclinical inflammation.

Intervention Type: OTHER

Eligibility Criteria

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

• 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

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Tufts Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pedram Hamrah, MD

Role: PRINCIPAL_INVESTIGATOR

MEEI

Locations

Massachusetts Eye and Ear Infirmary

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

13-149H

Identifier Type: -

Identifier Source: org_study_id