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

108 Participants Needed

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.

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 data supports the effectiveness of the treatment Quantitative Sensory Test for corneal nerve function?

Quantitative Sensory Testing (QST) is a reliable method for assessing nerve function over time, as shown in studies with healthy volunteers. It is used to evaluate nerve fiber function in various conditions, suggesting its potential usefulness in assessing corneal nerve function. ^{1 2 3 4 5}

Is Quantitative Sensory Testing (QST) safe for humans?

Quantitative Sensory Testing (QST) is generally considered safe for humans as it is a non-invasive method used to assess nerve function. It involves measuring how people perceive different sensations, like temperature or touch, and has been used in various clinical settings without reports of harm. ^{1 2 6 7 8}

How is the Quantitative Sensory Test for corneal nerve function different from other treatments?

The Quantitative Sensory Test is unique because it evaluates nerve function by measuring sensory responses, which is different from other methods that may involve direct contact or invasive procedures. This non-invasive approach can be particularly useful for assessing nerve function without the need for equipment sterilization or visual control, making it more convenient and potentially more sensitive than traditional methods. ^{1 9 10 11 12}

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.

Timeline

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

Treatment Details

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.

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],

Findings from Research

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Analysis of trigeminal nerve disorders after oral and maxillofacial intervention. [2021]

2. New Zealand 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. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Minimally Invasive Corneal Neurotization Provides Sensory Function, Protects Against Recurrent Ulceration, and Improves Visual Acuity. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Clinical grading of peripheral nerve problems. [2004]

5. United States pubmed.ncbi.nlm.nih.gov

Quantitative sensory testing: methodology, applications, and future directions. [2008]

6. United States pubmed.ncbi.nlm.nih.gov

Quantitative sensory testing: report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Quantitative sensory testing. [2022]

8. Germany pubmed.ncbi.nlm.nih.gov

[Quantitative sensory testing]. [2018]

9. Denmark pubmed.ncbi.nlm.nih.gov

Hypertonic saline test for ophthalmic nerve impairment. [2019]

10. England pubmed.ncbi.nlm.nih.gov

A new non-contact corneal aesthesiometer (NCCA). [2006]

11. United States pubmed.ncbi.nlm.nih.gov

Significance of quantitative sensory testing in the diagnosis of diabetic peripheral neuropathy. [2014]

12. United States pubmed.ncbi.nlm.nih.gov

Clinical application of the Swiss Liquid Jet Aesthesiometer for corneal sensitivity measurement. [2023]