Quantitative Sensory Testing for Corneal Nerve Function

Overseen By Nancy Gee, MPH

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Tufts Medical Center

No Placebo Group

Trial Summary

What is the purpose of this trial?

This study is designed to learn more about the impact different types of stimuli, such as heat, cold and vibration, can have on ocular pain response. This is called quantitative sensory testing (QST). Most procedures being performed in this study, except the QST, are standard of care which means they are performed during the participant's routine eye examination.

Research Team

Pedram Hamrah, MD

Principal Investigator

Tufts Medical Center

Eligibility Criteria

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.

Inclusion Criteria

I have Stage II NK with symptoms like less nerve density and reduced corneal sensation.

I am healthy with no eye surface symptoms, clear cornea, and normal feeling in my cornea.

I experience nerve pain that doesn't match my physical exams, confirmed by a special microscope test.

Exclusion Criteria

Pregnancy

Any major psychiatric illness including bipolar, psychosis, obsessive-compulsive disorder and major depression

I have not had eye surgery, eye infections, or eye injuries in the last 3 months.

Treatment Details

Interventions

• Quantitative Sensory Test (Other)

Trial Overview 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.

Participant Groups

Group I: Stage II Neurotrophic Keratopathy Experimental Treatment 1 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 Keratopathy Experimental Treatment 1 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 Individuals Experimental Treatment 1 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 Disease Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Tufts Medical Center

Lead Sponsor

Trials

264

Recruited

264,000+

Dompé Farmaceutici S.p.A

Industry Sponsor

Trials

53

Recruited

4,400+

Founded

:[-1880s implied start, exact date not specified],