Quantitative Sensory Testing for Corneal Nerve Function

Overseen By Nancy Gee, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Tufts Medical Center

Must not be taking: Anti-inflammatories, Steroids, Immunomodulators

Disqualifiers: Diabetes, Ocular surgery, Psychiatric illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand how different stimuli, such as heat, cold, and vibration, affect eye pain. The focus is on individuals with specific eye conditions, particularly neurotrophic keratopathy (where the cornea loses sensation) and dry eye disease. Participants will undergo quantitative sensory testing to measure how the nerves in the eyes respond to these stimuli. Individuals with dry eye symptoms for at least three months or specific corneal issues are suitable candidates for this study. Healthy individuals without any eye symptoms are also welcome to participate. As an unphased trial, this study allows participants to contribute to foundational research that could enhance the understanding and treatment of eye conditions.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you have been on regular anti-inflammatory, steroid, or immune-modulatory therapy in the last 3 months.

What prior data suggests that this quantitative sensory testing is safe for ocular pain response?

Research has shown that quantitative sensory testing (QST) helps study how factors like heat or cold affect eye pain. It primarily aids in understanding conditions such as neurotrophic keratopathy, where the eye's sensitivity decreases.

Participants who have undergone QST generally find it manageable, with no major reports of side effects, indicating the test's safety for humans. However, since this trial is in the "Not Applicable" phase, it focuses on gathering information rather than proving safety.

In studies of similar eye conditions, such as neurotrophic keratopathy, concerns about the safety of tests like QST have arisen. However, results from these studies have shown that these tests usually do not cause harm, suggesting QST is a safe option for studying eye conditions. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it uses Quantitative Sensory Testing (QST) to assess corneal nerve function, potentially offering a new way to understand and diagnose eye conditions like neurotrophic keratopathy and dry eye disease. Unlike traditional methods that focus solely on clinical observations and symptoms, QST provides a quantitative assessment of nerve function, which could lead to more personalized and precise treatments. By directly measuring corneal sensation and nerve density, this approach might reveal underlying issues that current treatments miss, paving the way for innovative therapies.

What evidence suggests that quantitative sensory testing is effective for assessing ocular pain response?

Research has shown that quantitative sensory testing (QST) helps assess the functioning of corneal nerves. In this trial, participants will be grouped into different arms based on their condition: Stage I Neurotrophic Keratopathy, Stage II Neurotrophic Keratopathy, Dry Eye Disease, and Healthy Individuals. Studies have found that about 58% of people with neurotrophic keratopathy experience reduced corneal sensation, meaning they can't sense stimuli as they normally would. QST can measure this. Another study found that about 12.6% of patients had reduced corneal sensitivity in at least one eye. QST identifies these nerve issues by testing reactions to heat, cold, and vibration. Understanding these reactions can help doctors better diagnose and treat eye conditions. ^{1 2 3 6 7}

Who Is on the Research Team?

Pedram Hamrah, MD

Principal Investigator

Tufts Medical Center

Are You a Good Fit for This Trial?

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 have had dry eye symptoms for over 3 months and have at least one sign of DED.

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

Exclusion Criteria

Pregnancy

Active ocular allergies

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Quantitative Sensory Testing (QST)

Participants undergo QST to assess corneal nerve functions using various stimuli such as heat, cold, and vibration

4 weeks

Multiple visits for QST assessments

Follow-up

Participants are monitored for safety and effectiveness after QST assessments

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Quantitative Sensory Test

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.

How Is the Trial Designed?

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],

Published Research Related to This Trial

Quantitative sensory testing (QST) shows potential in identifying sensory abnormalities in conditions like diabetic neuropathy, but there is no strong evidence from well-powered studies to confirm its effectiveness for specific disorders.

Due to variability between different QST systems and the lack of consensus on reproducibility, results from one system cannot be directly compared to another, highlighting the need for standardized methodologies in future research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quantitative sensory testing: report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology. Shy, ME., Frohman, EM., So, YT., et al.[2022]

The standardized quantitative sensory testing (QST) protocol demonstrated high reliability over a 10-week period in 22 healthy volunteers, indicating it can be a dependable tool for assessing sensory function.

Most QST parameters showed almost-perfect to substantial reliability, making it suitable for clinical trials, while also allowing for the definition of meaningful changes in sensory thresholds over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How stable are quantitative sensory testing measurements over time? Report on 10-week reliability and agreement of results in healthy volunteers. Nothnagel, H., Puta, C., Lehmann, T., et al.[2020]

Citations

1. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT05758753

NCT05758753 | QST for Corneal Nerve Function In this study, we propose to evaluate corneal nerve functions in patients with corneal nerve abnormalities by QST and correlate the nerve functions with ...

2. ctv.veeva.com ctv.veeva.com/study/qst-for-corneal-nerve-function

QST for Corneal Nerve Function - ClinicalTrials.Veeva In this study, we propose to evaluate corneal nerve functions in patients with corneal nerve abnormalities by QST and correlate the nerve ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11630729/

The THINK Study: Testing Hypoesthesia and the Incidence of ... Esthesiometry of ≤40 mm, indicating neurotrophic keratopathy, was detected in 18 (58%, 95% CI 39–75%) patients. Corneal higher-order aberrations ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12015737/

The Prevalence of Corneal Sensitivity Loss in Patients with ... Corneal sensitivity loss was observed in 9.4% of all eyes, and 12.6% of patients had reduced corneal sensitivity in at least one eye.

5. sciencedirect.com sciencedirect.com/science/article/pii/S0039625724000420

Neurotrophic keratopathy: General features and new ... Neurotrophic keratopathy is an uncommon degenerative corneal disorder characterized by compromised corneal sensory innervation.

6. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05758753/qst-for-corneal-nerve-function

QST for Corneal Nerve Function | Clinical Research 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.

7. tandfonline.com tandfonline.com/doi/full/10.2147/OPTH.S513005

The Prevalence of Corneal Sensitivity Loss in Patients with ... Corneal sensitivity loss was observed in 9.4% of all eyes, and 12.6% of patients had reduced corneal sensitivity in at least one eye.