Validation of a new imaging biomarker for neuropathic corneal pain

Prospective Study to Validate the Imaging Biomarker for Neuropathic Corneal Pain.

This study is testing a new imaging method to see if it can help doctors identify a specific type of nerve damage in the eye that causes severe pain, so they can better diagnose and treat people with neuropathic corneal pain.

Quick facts

• Study type: Observational
• Enrollment: 438 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Tufts Medical Center (Academic / other)
• Locations: 2 sites (Boston, Massachusetts and 1 other locations)
• Trial ID: NCT05653921 on ClinicalTrials.gov

What this trial studies

This study aims to establish the reliability and clinical utility of microneuromas identified through in vivo confocal microscopy as a diagnostic biomarker for neuropathic corneal pain (NCP). NCP is a severe type of ocular neuropathic pain that often goes underdiagnosed due to the absence of clinical signs. By utilizing non-invasive imaging techniques, the study will analyze corneal nerves in patients with NCP, dry eye disease, and healthy individuals to validate the presence of microneuromas as a distinguishing feature. The findings could lead to improved diagnosis and treatment strategies for patients suffering from NCP.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with symptoms of ocular discomfort, either diagnosed with dry eye disease or suspected of having neuropathic corneal pain.

Not a fit: Patients with no symptoms of ocular discomfort or those who do not meet the specific inclusion criteria for either the dry eye disease or neuropathic corneal pain groups may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a reliable diagnostic tool for identifying neuropathic corneal pain, leading to better-targeted treatments for affected patients.

How similar studies have performed: While the approach of using in vivo confocal microscopy for diagnosing neuropathic corneal pain is novel, similar studies have shown promise in utilizing imaging biomarkers for other neuropathic conditions.

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

Where this trial is running

Boston, Massachusetts and 1 other locations

• Tufts Medical Center — Boston, Massachusetts, United States (Recruiting)
• Scheie Eye Institute, University of Pennsylvania — Philadelphia, Pennsylvania, United States (Recruiting)

Study contacts

• Principal investigator: Pedram Hamrah, MD — Tufts Medical Center
• Study coordinator: Nancy Gee, MPH

Conditions Dry Eye Syndromes; Corneal Disease