NCT06364657

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

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

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 13 (actual)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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. 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.

Conditions

• Sjogren's Syndrome
• Dry Eye
• Neurotrophic Keratitis

Interventions

Type	Name	Description
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

Timeline

• Start date: 2024-07-01
• Primary completion: 2024-12-19
• Completion: 2024-12-19
• First posted: 2024-04-15
• Last updated: 2025-01-15

Locations

1 site across 1 country: United States