Clinical trial NCT04838223: Neurosensory Abnormalities in SymptomAtic Ocular Surface Patients (NASA)
Official title: Neurosensory Abnormalities in SymptomAtic Ocular Surface Patients (NASA)
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Dry Eye
Neuropathic Pain
Lead sponsor: Tufts Medical Center
Sponsor class: OTHER
Collaborators: name: CooperVision International Limited (CVIL)
name: Bausch & Lomb Incorporated
First posted: 2021-04-09
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 1,000 subjects will be enrolled for this study based on the above criteria:

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


Eligibility criteria: 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

Primary outcomes:
measure: To establish the prevalence of neuropathic corneal pain in patients with ocular surface discomfort.
timeFrame: Day 1
measure: To assess the overlap of neuropathic corneal pain with dry eye disease in patients in diseases that are currently thought to be mutually exclusive.
timeFrame: Day 1
measure: 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.
timeFrame: Day 1
Secondary outcomes:
measure: To assess the overlap of neuropathic corneal pain and contact lens discomfort.
timeFrame: 1 study visit
measure: To establish the prevalence of anxiety/depression in patients with neuropathic corneal pain patients.
timeFrame: Day 1
measure: To assess for differences in in vivo confocal microscopy measures between dry eye disease patients and neuropathic corneal pain patients.
timeFrame: Day 1
measure: To assess for subtypes of neuropathic corneal pain differences in in vivo confocal microscopy measures between dry eye disease patients and neuropathic corneal pain patients.
timeFrame: Day 1
Other outcomes:
Locations:
city: Azusa
country: United States
facility: Canyon City Eye Care
state: California
city: Pomona
country: United States
facility: Western University of Health Sciences
state: California
city: San Francisco
country: United States
facility: University of California at San Francisco - Francis I Proctor Foundation
state: California
city: Miami
country: United States
facility: Bruce W. Carter VA Medical Center
state: Florida
city: Chicago
country: United States
facility: University of Illinois at Chicago
state: Illinois
city: Chicago
country: United States
facility: Illinois College of Optometry
state: Illinois
city: Pittsburg
country: United States
facility: Kannarr Eye Care
state: Kansas
city: Baltimore
country: United States
facility: University of Maryland
state: Maryland
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Korb & Associates
state: Massachusetts
city: Saint Louis
country: United States
facility: Midwest Vision Research Foundation at Prepose Vision Institute
state: Missouri
city: Saint Louis
country: United States
facility: Ophthalmology Associates
state: Missouri
city: Shelby
country: United States
facility: Vita Eye Clinic
state: North Carolina
city: Westlake
country: United States
facility: SkyVision Centers
state: Ohio
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania (Scheie Eye Institute Perelman)
state: Pennsylvania
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
Study officials:
affiliation: Tufts Medical Center
name: Pedram Hamrah, MD
role: PRINCIPAL_INVESTIGATOR
References: