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

The aim of this study is establish the reliability and clinical utility of microneuromas as identified via in vivo confocal microscopy as the diagnostic biomarker for NCP.

Inclusion Criteria:All Subjects:18 years of age or olderAbility to consentBest corrected visual acuity of 20/40 or better in each eyeDry Eye Disease Group:Chief complaint is ocular surface discomfort or dry eye disease, but subject reports no ocular pain on OPAS questionnaireSymptoms lasting at least 3 monthsPresence of at least two of the following within the same eye:Anesthetized Schirmer score < 10mmCorneal staining of >3/15 based on NEI scaleTear break up time < 10 secondsNeuropathic Corneal Pain Group:Chief complain is ocular surface discomfort or dry eye diseaseSymptoms lasting at least 3 monthsAll of the following in both eyes:Anesthetized Schirmer score > 10 mmCorneal staining of less than or equal to 3/15 based on NEI scaleTear break up time > 10 secondsControl Group:No symptoms of ocular surface discomfort or dry eye diseaseAll of the following in both eyesAnesthetized Schirmer score > 10 mmCorneal staining of less than or equal to 3/15 based on NEI scaleTear break up time > 10 secondsThe same sex and within 5 years of age of a patient within the NCP group.Exclusion Criteria:Pregnant or nursingIrregular corneal diseaseOcular surgery in the past 3 monthsOcular infection in the past 3 monthsActive ocular allergiesParticipation in a study that could potentially impact the IVCM in the opinion of the investigator