Quantitative Sensory Testing for Corneal Nerve Function

N/A

Waitlist Available

Led By Pedram Hamrah, MD

Research Sponsored by Tufts Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from visit 1 up to 4 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial studies the effects of heat, cold, and vibration on eye pain during a routine eye exam. #QST #MedicalResearch

Who is the study for?

This trial is for people with early-stage Neurotrophic Keratopathy (NK), Dry Eye Disease (DED) symptoms for at least 3 months, or neuropathic corneal pain (NCP). Healthy individuals can also join. It's not for those with major psychiatric illnesses, recent surgeries, certain diseases like sarcoidosis, allergies to BAK in eye drops, non-English speakers, diabetics, or anyone on anti-inflammatory/steroid treatments recently.

What is being tested?

The study tests how heat, cold and vibration stimuli affect ocular pain response using Quantitative Sensory Testing (QST). Except QST, all other procedures are routine eye exams. Participants include those with NK stages I & II, DED sufferers and healthy volunteers.

What are the potential side effects?

Since most of the procedures are standard eye examinations and the main intervention is a sensory test that does not involve medication or surgery there may be minimal side effects such as temporary discomfort from the testing stimuli.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from visit 1 up to 4 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from visit 1 up to 4 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and from visit 1 up to 4 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Differences in mechanical stimulus pain threshold across the 4 study arms

Differences in thermal stimulus pain threshold across the 4 study arms

Mechanical stimulus response to QST on site of trigeminal nerve first branch, as assessed by vibration detection threshold (VDT)

+1 more

Secondary study objectives

To compare QST response differences between trigeminal nerve first branch and forearm in patients.

To correlate symptom severity as assessed by the Ocular Surface Disease Index (OSDI), to stimulus response across the 4 interventional arms.

To correlate the QST responses with morphological changes of corneal nerves detected by IVCM

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Group I: Stage II Neurotrophic KeratopathyExperimental Treatment1 Intervention

Clinical findings of corneal epithelial defect with smooth and rolled edges, decreased nerve density as assessed by in vivo confocal microscopy (IVCM), and decreased corneal sensation.

Group II: Stage I Neurotrophic KeratopathyExperimental Treatment1 Intervention

Clinical findings of corneal hyperplasia and irregularity, scattered small facets of dried epithelium, decreased nerve density as assessed by in vivo confocal microscopy (IVCM), and decreased corneal sensation.

Group III: Healthy IndividualsExperimental Treatment1 Intervention

Absence of any ocular symptoms, absence of surface findings (including corneal or conjunctival staining, corneal scar or surgical wound), and normal corneal sensation.

Group IV: Dry Eye DiseaseExperimental Treatment1 Intervention

Symptoms of dry eye disease for at least 3 months, supported by clinical finding of decreased tear film break-up time or ocular surface staining. Normal corneal sensation.

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