Differences in Corneal Structure and Function in Patients With Sjogrens vs. Non-Sjogrens Dry Eye

NCT06364657 | Terminated

• 1 other identifier: IRB00439625
• Study Type: observational
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

In this study the investigators plan to enroll three groups of patients: non-Sjogren's dry eye, Sjogren's dry eye and controls. The study has the following primary goals:

1. 1.To determine whether dry eye is associated with reduced corneal sensation
2. 2.To determine whether reduced corneal sensation is due to the severity of the dry eye, the type of dry eye (primarily aqueous deficient versus primarily evaporative) or entirely related to the presence of Sjogren's
3. 3.To determine whether corneal sensation is associated with ocular or systemic pain symptoms Additionally, the study aims to compare the novel corneal esthesiometer measurements to confocal biomicroscopy findings in determining neurotrophic keratitis (NK) and assess correlations between corneal sensation.

Conditions

Sjogren's Syndrome; Dry Eye; Neurotrophic Keratitis

Keywords

Sjogren's Syndrome; Dry Eye; Neurotrophic Keratitis

Outcome Measures

Primary Outcomes (2)

• Corneal Epithelium health

  Measuring epithelial staining score and epithelial thickness map using anterior segment Optical coherence tomography (OCT)

  1 Day

• Corneal Nerve health

  Corneal sensation using non-contact esthesiometer and corneal nerve density and morphology using non-contact confocal biomicroscopy

  1 Day

Secondary Outcomes (2)

• Correlations Between Corneal Staining Score

  1 Day

• Correlations Between Patient Symptoms

  1 Day

Study Arms (3)

Sjogren's related dry-eye

Patients over the age of 18 years with known dry eye with underlying Sjogren's syndrome. Includes a previous diagnosis of dry eye made by an eye care specialist and a previous diagnosis of Sjogren's made according to the 2016 revised Sjogren's classification criteria.

Diagnostic Test: Eye Exam

non-Sjogren's related dry-eye

Patients over the age of 18 years with known dry eye without underlying Sjogren's syndrome. Includes a previous diagnosis of dry eye made by an eye care specialist and a previous diagnosis of Sjogren's according to the 2016 revised Sjogren's classification criteria was definitively excluded

Diagnostic Test: Eye Exam

Control

Age-matched healthy controls with no known history of ocular surface diseases or dry eye or any underlying autoimmune disease

Diagnostic Test: Eye Exam

Interventions

Eye Exam DIAGNOSTIC_TEST

* Symptom Questionnaires (OSDI, eye dryness VAS, visual fatigue VAS, eye discomfort VAS) * Pain scale questionnaire \[Wong-Baker Faces Pain Rating Scale and Ocular Pain Assessment Survey * Best spectacle-corrected visual acuity (BSCVA) as measured by Snellen chart followed by Mars contrast sensitivity test. * Corneal esthesiometer for measurement of corneal sensation * Schirmer's without topical anesthesia * Corneal epithelial thickness sand endothelial cell count using Anterior Segment Optical Coherence Tomography (AS-OCT) * Staining for dry eye: * Tear film break-up time (BUT) using fluorescein. * Fluorescein staining (National Eye Institute (NEI) and Ocular staining score (OSS)) * Lissamine green staining (OSS and Oxford) * Non-contact confocal biomicroscopy for morphology of the ocular surface

Control; Sjogren's related dry-eye; non-Sjogren's related dry-eye

Eligibility Criteria

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

Study Population

Adults aged 18 years or older, with and without Sjogren's-related dry eye, and no previous diagnosis of dry eye or other ocular surface disease.

You may qualify if:

• Male or female aged 18 or older
• Capacity to give informed consent
• Self-reported literacy
• Best corrected visual acuity at distance 20/40 in each eye
• a previous diagnosis of dry eye made by an eye care specialist
• a previous diagnosis of Sjogren's made according to the 2016 revised Sjogren's classification criteria

You may not qualify if:

• ● Age less than 18 years
• Physical or mental issues, illiteracy, or language problems that might possibly interfere with reading ability or other condition that would preclude successful participation in this study
• Contact lens wear within 10 days of enrollment
• Any intraocular surgery (including cataract surgery) within the last 3 months
• Any minor ocular surgery including tear duct cauterization or plugs within the last 30 days
• Any history of corneal surgery (including LASIK/PRK) or cosmetic lid surgery in the past 12 months
• Any history of glaucoma surgery (e.g., trabeculectomy or a tube shunt)
• Best corrected vision worse than 20/40
• Known history of severe ocular surface disease that might cause corneal haze and interfere with corneal staining score including but not limited to graft-versus-host disease, mucous membrane pemphigoid, atopic keratoconjunctivitis
• Presence of keratoconus
• Concurrent epithelial corneal disease or dystrophy (e.g., anterior basement membrane disease, pterygium, or scarring) that might affect the corneal staining score
• Previous use of OXERVATE® for neurotrophic keratitis
• Neurotrophic keratoconjunctivitis or corneal/conjunctival scarring (history of herpes simplex virus or varicella zoster virus keratitis)
• Any blepharitis eyelid procedures such as Intense Pulsed Light (IPL), low level light treatment therapy, LipiFlow®, or nasolacrimal duct probing in the last 30 days prior to the study visit
• Any acupuncture or physical therapy on the face or head within the past 3 months

Sponsors & Collaborators

• Johns Hopkins University: lead
• Dompe U.S. Inc: collaborator

Study Sites (1)

Johns Hopkins Hospital Wilmer Eye Institute

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Sjogren's Syndrome; Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Arthritis, Rheumatoid; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Xerostomia; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Lacrimal Apparatus Diseases; Eye Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Esen K Akpek, MD

  Johns Hopkins Hospital Wilmer Eye Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2024
• First Posted: April 15, 2024
• Study Start: July 1, 2024
• Primary Completion: December 19, 2024
• Study Completion: December 19, 2024
• Last Updated: January 15, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)