Neurosensory Abnormalities in SymptomAtic Ocular Surface Patients (NASA)

Tufts Medical Center1,000 enrolled

Overview

This study is designed to measure how common nerve abnormalities are within a group of patients who feel discomfort within their eyes.

Study Type

OBSERVATIONAL

Enrollment

1,000

Conditions

Dry Eye Neuropathic Pain

Interventions

Hyperosmolar ResponseOTHER

A single drop of hypertonic sodium chloride solution at room temperature will be instilled in each eye and change in pain/other symptoms after up to 90 seconds of application (to account for any initial irritation symptoms) will be observed.

Proparacaine Challenge TestOTHER

A single drop of Proparacaine hydrochloride ophthalmic solution, (Alcaine®, 0.5%) will be used on each eye respectively and any change in pain/other symptoms will be noted after 90 seconds (to account for initial discomfort from the preservative in Proparacaine solution).

Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) Optional; only for Contact Lens WearersOTHER

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Presents with ocular surface discomfort or for dry eye care * Best corrected visual acuity of 20/40 or better in each eye * Subject reported duration of symptoms of at least 3 months * 100 subjects will be required to be habitual contact lens wearers as defined by use of contact lenses at least 5 hours per day at least 5 days per week for the last year. Exclusion Criteria: * Use of contact lenses on the day of the visit * Pregnant or nursing * Irregular corneas (e.g., ectatic disease, transplantation, or corneal dystrophies) * Ocular surgery in the past 3 months * Ocular infection in the past 3 months * Active ocular allergies

Locations (16)

Canyon City Eye Care

Azusa, California, United States

Western University of Health Sciences

Pomona, California, United States

Outcomes

Primary Outcomes

To establish the prevalence of neuropathic corneal pain in patients with ocular surface discomfort.

As measured by the percent of subjects who report increased ocular surface discomfort upon challenge with hyperosmolar saline.

Time frame: Day 1

To assess the overlap of neuropathic corneal pain with dry eye disease in patients in diseases that are currently thought to be mutually exclusive.

As measured by the percent of subjects who report ocular surface discomfort, and either do or do not exhibit signs of dry eye disease as defined by Tear Break Up Time, Schirmer's test, and staining, and have an increase in Visual Analog Scale score of more than 2 steps upon instillation of hypertonic saline.

Time frame: Day 1

To establish the prevalence of subtypes of patients with neuropathic corneal pain or with a neuropathic component of dry eye in patients with ocular surface discomfort.

As measured by the percent of subjects who report ocular surface discomfort, and have a decrease, partial decrease, or no change in Visual Analog Score score upon instillation of proparacaine.

Time frame: Day 1

Secondary Outcomes

To assess the overlap of neuropathic corneal pain and contact lens discomfort.

Percent of contact lens wearers who report discomfort when wearing their contact lenses, and either do or do not exhibit signs of dry eye disease as defined by TBUT, Schirmer's test, and staining, and have an increase in VAS score of more than 2 steps upon instillation of hypertonic saline.

Time frame: 1 study visit

To establish the prevalence of anxiety/depression in patients with neuropathic corneal pain patients.

Percent of subjects who report increased ocular surface discomfort upon challenge with hyperosmolar saline and a history of anxiety/depression.

Data from ClinicalTrials.gov

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