Prospective Study to Validate the Imaging Biomarker for NCP (R33)

Launched by TUFTS MEDICAL CENTER · Dec 8, 2022

Keywords

ClinConnect Summary

This clinical trial is looking at a new way to diagnose a condition called Neuropathic Corneal Pain (NCP) by using a special imaging technique called in vivo confocal microscopy to identify small nerve structures known as microneuromas. The goal is to see if these microneuromas can be a reliable indicator for diagnosing NCP, which is often associated with dry eye symptoms and discomfort in the eyes. The study is currently recruiting participants aged 18 and older, and it includes people with different types of eye conditions, such as those experiencing chronic dry eye symptoms or specific types of corneal pain.

To be eligible for the trial, participants should have ongoing eye discomfort for at least three months and meet certain vision and symptom criteria. Those without any eye discomfort will also be included as a control group for comparison. Throughout the study, participants will undergo eye exams and imaging tests to help researchers understand the connection between the microneuromas and the symptoms of their eye conditions. It's important to note that certain medical conditions or recent surgeries may prevent some individuals from participating. Overall, this trial aims to improve the diagnosis and understanding of painful eye conditions, which could lead to better treatment options in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• All Subjects:
• • 1. 18 years of age or older
• • 2. Ability to consent
• • 3. Best corrected visual acuity of 20/40 or better in each eye
• Dry Eye Disease Group:
• • 1. Chief complaint is ocular surface discomfort or dry eye disease, but subject reports no ocular pain on OPAS questionnaire
• • 2. Symptoms lasting at least 3 months
• 3. Presence of at least two of the following within the same eye:
• • 1. Anesthetized Schirmer score =/\< 10mm
• • 2. Corneal staining of \>3/15 based on NEI scale
• • 3. Tear break up time \< 10 seconds
• Neuropathic Corneal Pain Group:
• • 1. Chief complain is ocular surface discomfort or dry eye disease
• • 2. Symptoms lasting at least 3 months
• 3. All of the following in both eyes:
• • 1. Corneal staining of less than or equal to 3/15 based on NEI scale
• • 2. Tear break up time =/\> 10 seconds
• • 4. Must have at least 25% peripheral pain
• • 5. Subject reported discomfort prior to drop response testing of at least 3 out of 10
• Control Group:
• • 1. No symptoms of ocular surface discomfort or dry eye disease
• • 2. All of the following in both eyes
• • 1. Anesthetized Schirmer score \> 10 mm
• • 2. Corneal staining of less than or equal to 3/15 based on NEI scale
• • 3. Tear break up time \> 10 seconds
• • 3. The same sex and within 5 years of age of a patient within the NCP group.
• Exclusion Criteria:
• • 1. Pregnant or nursing
• • 2. Irregular corneal disease
• • 3. Ocular surgery in the past 3 months
• • 4. Ocular infection in the past 3 months
• • 5. Active ocular allergies
• • 6. Participation in a study that could potentially impact the IVCM in the opinion of the investigator
• • 7. Current use of corneal nerve regeneration therapy that has been on-going for 3 months or more.
• • 8. For NCP group only, patients for whom their pain and symptoms can be attributed to other causes in the opinion of the investigator