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

NCT06364657 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 13

Last updated 2025-01-15

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Esen K Akpek, MD · Johns Hopkins Hospital Wilmer Eye Institute

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-07-01
Primary Completion
2024-12-19
Completion
2024-12-19

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06364657 on ClinicalTrials.gov