Quantitative Sensory Testing for Corneal Nerve Function
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.12345Why 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.12367
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Quantitative Sensory Testing (QST)
Participants undergo QST to assess corneal nerve functions using various stimuli such as heat, cold, and vibration
Follow-up
Participants are monitored for safety and effectiveness after QST assessments
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?
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Treatment groups
Experimental Treatment
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.
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.
Absence of any ocular symptoms, absence of surface findings (including corneal or conjunctival staining, corneal scar or surgical wound), and normal corneal sensation.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Tufts Medical Center
Lead Sponsor
Dompé Farmaceutici S.p.A
Industry Sponsor
Published Research Related to This Trial
Citations
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 ...
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 ...
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 ...
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.
Neurotrophic keratopathy: General features and new ...
Neurotrophic keratopathy is an uncommon degenerative corneal disorder characterized by compromised corneal sensory innervation.
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centerwatch.com
centerwatch.com/clinical-trials/listings/NCT05758753/qst-for-corneal-nerve-functionQST 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.
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.
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