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

Role of Neurotrophic Keratitis Versus Severity of Tear Film and Ocular Surface Parameters in Determining the Differences in Corneal Structure and Function in Patients With Sjogrens vs. Non-Sjogrens Dry Eye

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. To determine whether dry eye is associated with reduced corneal sensation
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. 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.

Study Overview

• Status: Not yet recruiting
• Conditions: Dry Eye; Neurotrophic Keratitis; Sjogren's Syndrome
• Intervention / Treatment: Diagnostic test: Eye Exam

• Study Type: Observational
• Enrollment (Estimated): 120

Contacts and Locations

• Study Contact: Name: Richard C Medina, BA; Phone Number: 626-343-3967; Email: rmedin19@jh.edu

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins Hospital Wilmer Eye Institute
      • Contact: Esen K Akpek, MD; Phone Number: 410-955-5490; Email: esakpek@jhmi.edu
      • Sub-Investigator: Lee W Guo, OD
      • Sub-Investigator: Michelle M Hessen, OD
      • Principal Investigator: Esen K Akpek, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• 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.

Description

Inclusion Criteria:

• 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

• Signed Institutional Review Board (IRB)-approved consent agreeing to the terms of the study For Sjogren's-related dry eye, the below inclusion criteria will be required

  • 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

Exclusion Criteria:

• ● 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
  • Current smoker (within the past year)
  • Pregnant or nursing
  • Artificial tear use within 2 hours of study visit
  • Topical ophthalmic non-steroidal anti-inflammatory drug use 24 hours before the study visit
  • History of taking or current use of topical glaucoma drops or neurostimulation drugs or devices for treating dry eye
  • History or current intravitreal injections for macular degeneration
  • History of continuous positive airway pressure usage in the past 3 months
  • Any concurrent medical condition that in the judgment of the PI might interfere with the conduct of the study, confound the interpretation of the study results.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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
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; 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; Age-matched healthy controls with no known history of ocular surface diseases or dry eye or any underlying autoimmune disease	Diagnostic test: Eye Exam; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlations Between Corneal Staining Score	Correlations between corneal staining score with visual parameters, epithelial thickness map, corneal nerve density and morphology, and corneal sensation	1 Day
Correlations Between Patient Symptoms	Correlations between the patient symptoms and above corneal findings using Ocular Surface Disease Index (OSDI), Visual Acuity Scale (VAS), and pain scale questionnaire	1 Day

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Investigators: Principal Investigator: Esen K Akpek, MD, Johns Hopkins Hospital Wilmer Eye Institute

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2024
• Primary Completion (Estimated): July 31, 2025
• Study Completion (Estimated): July 31, 2027

Study Registration Dates

• First Submitted: April 4, 2024
• First Submitted That Met QC Criteria: April 9, 2024
• First Posted (Estimated): April 15, 2024

Study Record Updates

• Last Update Posted (Estimated): April 15, 2024
• Last Update Submitted That Met QC Criteria: April 9, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Sjogren's Syndrome; Dry Eye; Neurotrophic Keratitis
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Eye Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Stomatognathic Diseases; Mouth Diseases; Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Corneal Diseases; Arthritis, Rheumatoid; Xerostomia; Salivary Gland Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca; Keratitis; Sjogren's Syndrome
• Other Study ID Numbers: IRB00439625

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No