Neurosensory Abnormalities in SymptomAtic Ocular Surface Patients (NASA)
- Conditions
- Neuropathic PainDry Eye
- Interventions
- Other: Hyperosmolar ResponseOther: Proparacaine Challenge TestOther: Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) Optional; only for Contact Lens WearersOther: Ocular Pain Assessment Survey (OPAS)Other: Visual Analogue Questionnaire
- Registration Number
- NCT04838223
- Lead Sponsor
- Tufts Medical Center
- Brief Summary
This study is designed to measure how common nerve abnormalities are within a group of patients who feel discomfort within their eyes.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 1000
- 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.
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Neuropathic Corneal Pain with Ocular Surface Discomfort Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) Optional; only for Contact Lens Wearers Participants diagnosed with neuropathic corneal pain with ocular surface discomfort Neuropathic Corneal Pain with Ocular Surface Discomfort Visual Analogue Questionnaire Participants diagnosed with neuropathic corneal pain with ocular surface discomfort Neuropathic Corneal Pain with Dry Eye Disease Hyperosmolar Response Participants diagnosed with dry eye disease and neuropathic corneal pain Neuropathic Corneal Pain with Dry Eye Disease Ocular Pain Assessment Survey (OPAS) Participants diagnosed with dry eye disease and neuropathic corneal pain Neuropathic Corneal Pain with Ocular Surface Discomfort Ocular Pain Assessment Survey (OPAS) Participants diagnosed with neuropathic corneal pain with ocular surface discomfort Neuropathic Corneal Pain with Ocular Surface Discomfort Hyperosmolar Response Participants diagnosed with neuropathic corneal pain with ocular surface discomfort NCP or Dry Eye in patients with ocular surface discomfort Visual Analogue Questionnaire Participants diagnosed with neuropathic corneal pain or with a neuropathic component of dry eye in patients with ocular surface discomfort Neuropathic Corneal Pain with Ocular Surface Discomfort Proparacaine Challenge Test Participants diagnosed with neuropathic corneal pain with ocular surface discomfort NCP or Dry Eye in patients with ocular surface discomfort Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) Optional; only for Contact Lens Wearers Participants diagnosed with neuropathic corneal pain or with a neuropathic component of dry eye in patients with ocular surface discomfort Neuropathic Corneal Pain with Dry Eye Disease Proparacaine Challenge Test Participants diagnosed with dry eye disease and neuropathic corneal pain Neuropathic Corneal Pain with Dry Eye Disease Visual Analogue Questionnaire Participants diagnosed with dry eye disease and neuropathic corneal pain NCP or Dry Eye in patients with ocular surface discomfort Hyperosmolar Response Participants diagnosed with neuropathic corneal pain or with a neuropathic component of dry eye in patients with ocular surface discomfort Neuropathic Corneal Pain with Dry Eye Disease Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) Optional; only for Contact Lens Wearers Participants diagnosed with dry eye disease and neuropathic corneal pain NCP or Dry Eye in patients with ocular surface discomfort Proparacaine Challenge Test Participants diagnosed with neuropathic corneal pain or with a neuropathic component of dry eye in patients with ocular surface discomfort NCP or Dry Eye in patients with ocular surface discomfort Ocular Pain Assessment Survey (OPAS) Participants diagnosed with neuropathic corneal pain or with a neuropathic component of dry eye in patients with ocular surface discomfort
- Primary Outcome Measures
Name Time Method To establish the prevalence of neuropathic corneal pain in patients with ocular surface discomfort. Day 1 As measured by the percent of subjects who report increased ocular surface discomfort upon challenge with hyperosmolar saline.
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. Day 1 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.
To assess the overlap of neuropathic corneal pain with dry eye disease in patients in diseases that are currently thought to be mutually exclusive. Day 1 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.
- Secondary Outcome Measures
Name Time Method To establish the prevalence of anxiety/depression in patients with neuropathic corneal pain patients. Day 1 Percent of subjects who report increased ocular surface discomfort upon challenge with hyperosmolar saline and a history of anxiety/depression.
To assess the overlap of neuropathic corneal pain and contact lens discomfort. 1 study visit 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.
To assess for differences in in vivo confocal microscopy measures between dry eye disease patients and neuropathic corneal pain patients. Day 1 As measured by dendritic cell density, nerve fiber density, and microneuroma density
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. Day 1 As measured by dendritic cell density, nerve fiber density, and microneuroma density
Trial Locations
- Locations (16)
Canyon City Eye Care
🇺🇸Azusa, California, United States
Western University of Health Sciences
🇺🇸Pomona, California, United States
Midwest Vision Research Foundation at Prepose Vision Institute
🇺🇸Saint Louis, Missouri, United States
SkyVision Centers
🇺🇸Westlake, Ohio, United States
Vita Eye Clinic
🇺🇸Shelby, North Carolina, United States
University of California at San Francisco - Francis I Proctor Foundation
🇺🇸San Francisco, California, United States
University of Maryland
🇺🇸Baltimore, Maryland, United States
Ophthalmology Associates
🇺🇸Saint Louis, Missouri, United States
Korb & Associates
🇺🇸Boston, Massachusetts, United States
Hospital of the University of Pennsylvania (Scheie Eye Institute Perelman)
🇺🇸Philadelphia, Pennsylvania, United States
Bruce W. Carter VA Medical Center
🇺🇸Miami, Florida, United States
University of Illinois at Chicago
🇺🇸Chicago, Illinois, United States
Baylor College of Medicine
🇺🇸Houston, Texas, United States
Illinois College of Optometry
🇺🇸Chicago, Illinois, United States
Tufts Medical Center
🇺🇸Boston, Massachusetts, United States
Kannarr Eye Care
🇺🇸Pittsburg, Kansas, United States