Corneal DiseaseNCT05758753
QST for Corneal Nerve Function
A study testing Quantitative Sensory Test in people with Corneal Disease and Neuropathy, run by Tufts Medical Center at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Corneal Disease, Neuropathy, Dry Eye Disease
- What is being tested?
- Quantitative Sensory Test
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteUnited States
- Study dates
- 16 May 2023to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Group 1: Stage I Neurotrophic Keratopathy (NK)
- Clinical findings of Stage I NK
- Decreased nerve density by IVCM
- Decreased corneal sensation
- Group 2: Stage II NK
- Clinical findings of Stage II NK
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- Decreased nerve density by IVCM
- Decreased corneal sensation
- Group 3: Dry Eye Disease (DED)
- Symptoms of DED at least 3 months
- Presence of at least one of the following DED signs; tear film break-up time lower than 7, ocular surface staining more than +1 based on NIH scale
- Normal or mildly effected corneal sensation
- Group 4: Healthy Individuals
- Absence of any ocular surface symptoms
- Absence of ocular surface findings
- Transparent and clear cornea
- Normal corneal sensation
- Group 5: NCP
- Presence of neuropathic symptoms AND
- Symptoms out of proportion to clinical findings AND
- Nerve abnormalities detected by in vivo confocal microscopy
Who cannot join
- History of diabetes
- History of ocular surgery, corneal infection, or corneal injury within the last 3 months
- Systemic regular anti-inflammatory and/or steroid and/or immune-modulatory therapy in the last 3 months
- Active ocular allergies
- Any major psychiatric illness including bipolar, psychosis, obsessive-compulsive disorder and major depression
- Pregnancy
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- History of surgery within the last 3 months
- History of , sarcoidosis, GVHD or collagen vascular disease
- Allergic to benzalkonium chloride "BAK" (an eye-drop preservative)
- Concurrent enrollment in other studies that in the opinion of the investigator will interfere with the results of this study
- Non-English speakers
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Efficacy of Quantitative Sensory Test (QST) in Assessing Corneal Nerve Functions in Patients With Ocular Surface Diseases
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.
Read the detailed description
Quantitative Sensory Test (QST) is a non-invasive neurophysiological method that refers to a group of procedures that assess the perceptual responses to systematically applied and quantifiable sensory stimuli for the purpose of characterizing somatosensory function or dysfunction.
In this study, we propose to evaluate corneal nerve functions in patients with corneal nerve abnormalities by QST and correlate the nerve functions with symptoms, clinical signs and nerve morphology detected by In-Vivo Confocal Microscopy (IVCM). Identification of corneal nerve functions and correlations with other findings may help us to understand underlying pathological mechanisms of the disease and may guide us toward new treatment targets.
We hypothesize that, QST may provide us detailed information about corneal nerve function alterations and may correlate with morphological nerve changes detected by IVCM.
- Conditions
- Corneal Disease, Neuropathy, Dry Eye Disease, Neurotrophic Keratitis
- Being tested
- Quantitative Sensory Test
- Keywords
- Quantitative Sensory Test
- Medical subject headings
- Corneal Diseases, Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quantitative Sensory TestDevice
Quantitative Sensory Test (Medoc Ltd, Israel), QST is a non-invasive neurophysiological method that refers to a group of procedures that assess the perceptual responses to systematically applied and quantifiable sensory stimuli (modalities including heat, cold and vibration) for the purpose of characterizing somatosensory function or dysfunction. For this test, subjects will be seated comfortably on a chair in a quiet room, or laying supine in a horizontal examination chair, with ambient temperature of 24-25◦ C. Medial upper eyelid; just below the supraorbital notch, nasolacrimal sac area; 4-5 mm medial to nasal cantus, and non-dominant forearm will be used as test sites. Patients will be instructed in detail of the nature of the test and the need to react attentively and promptly to change in temperatures.
| Study group | Role | What they receive |
|---|---|---|
| Stage I Neurotrophic Keratopathy | Experimental | 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. Receives: Device: Quantitative Sensory Test |
| Stage II Neurotrophic Keratopathy | Experimental | 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. Receives: Device: Quantitative Sensory Test |
| Dry Eye Disease | Experimental | 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. Receives: Device: Quantitative Sensory Test |
| Healthy Individuals | Experimental | Absence of any ocular symptoms, absence of surface findings (including corneal or conjunctival staining, corneal scar or surgical wound), and normal corneal sensation. Receives: Device: Quantitative Sensory Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Thermal stimulus response to QST on site of trigeminal nerve first branch, as assessed by cold detection threshold (CDT) and hot detection threshold (HDT)
Cold and heat sensation thresholds will be evaluated by placing a 16 mm x 16 mm probe over the skin on the site to be tested, and an average of 3 reading while be taken for each stimuli. Participants will receive successive ramps of gradually decreasing or increasing temperature, starting from a resting neutral temperature of 32°C. Participants will be instructed to press a response button when a thermal sensation (either cold or warm) is perceived.
Measured: From visit 1 up to 4 weeks
Mechanical stimulus response to QST on site of trigeminal nerve first branch, as assessed by vibration detection threshold (VDT)
Vibration sensation threshold will be evaluated by placing a 16 mm x 16 mm probe over the skin on the site to be tested, and an average of 3 reading while be taken. Participants will receive successive ramps of gradually decreasing or increasing vibration, starting from. Participants will be instructed to press a response button when a mechanical sensation is perceived.
Measured: From visit 1 up to 4 weeks
Differences in thermal stimulus pain threshold across the 4 study arms
Cold pain threshold (CPT) and heat pain threshold (HPT) will be measured by asking participants to press a response button when they first feel a pain or discomfort from probe on QST testing
Measured: From visit 1 up to 4 weeks
Differences in mechanical stimulus pain threshold across the 4 study arms
Vibration pain threshold (VPT) will be measured by asking participants to press a response button when they first feel a pain or discomfort from vibration probe on QST testing
Measured: From visit 1 up to 4 weeks
Secondary outcomes (3)
To correlate the QST responses with morphological changes of corneal nerves detected by IVCM
In vivo confocal microscopy (IVCM) imaging will be performed to observe for any morphological nerve changes; such as decreased nerve density, nerve tortuosity presence of microneuromas.
Measured: From visit 1 up to 4 weeks
To correlate symptom severity as assessed by the Ocular Surface Disease Index (OSDI), to stimulus response across the 4 interventional arms.
Ocular Surface Disease Index (OSDI) questionnaire A 12-item questionnaire designed to provide a rapid assessment of the symptoms of ocular irritation consistent with dry eye disease and their impact on vision-related functioning. The 12 items of the OSDI questionnaire are graded on a scale of 0 to 4, where 0 indicates none of the time; 1, some of the time; 2, half of the time; 3, most of the time; and 4, all of the time. The total OSDI score is then calculated on the basis of the following formula: OSDI= [(sum of scores for all questions answered) x 100]/[(total number of questions answered) x 4]. Higher OSDI scores represent greater severity of symptoms.
Measured: From visit 1 up to 4 weeks
To compare QST response differences between trigeminal nerve first branch and forearm in patients.
Measurement of stimuli detection thresholds, pain thresholds and pain ranges for different stimuli (cold, heat and vibration) type in study groups at 3 different periocular sites (just below supraorbital notch, lateral canthus, inferior orbital bone; 1 cm lateral of medial canthus) and non-dominant hand hypothenar eminence (as a reference site)
Measured: From visit 1 up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2023
- Study start16 May 2023
- Primary completion31 Oct 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Why it stopped: PI is leaving institution. USF will likely resume study activity but TMC is no longer conitinuing study activity.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Corneal DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tufts Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Dompé Farmaceutici S.p.A
- Responsible party
- Sponsor
- Investigators
- Pedram Hamrah, MD, Principal investigator, Tufts Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05758753
- Sponsor's protocol ID
- STUDY00002510
- Status last verified
- Jan 2026
- First submitted
- 6 Sep 2022
- Last updated
- 8 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Quantitative Sensory Test (QST) in Assessing Corneal Nerve Functions in Patients With Ocular Surface Diseases
- ClinicalTrials.gov ID
- NCT05758753
- Acronym / sponsor ID
- STUDY00002510
- Conditions
- Corneal Disease, Neuropathy, Dry Eye Disease, Neurotrophic Keratitis
- Keywords
- Quantitative Sensory Test
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: PI is leaving institution. USF will likely resume study activity but TMC is no longer conitinuing study activity.
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Tufts Medical CenterUniversity, hospital or other
- Collaborators
- Dompé Farmaceutici S.p.A
- Study start
- 16 May 2023 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 7 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Quantitative Sensory Test (QST) is a non-invasive neurophysiological method that refers to a group of procedures that assess the perceptual responses to systematically applied and quantifiable sensory stimuli for the purpose of characterizing somatosensory function or dysfunction.
In this study, we propose to evaluate corneal nerve functions in patients with corneal nerve abnormalities by QST and correlate the nerve functions with symptoms, clinical signs and nerve morphology detected by In-Vivo Confocal Microscopy (IVCM). Identification of corneal nerve functions and correlations with other findings may help us to understand underlying pathological mechanisms of the disease and may guide us toward new treatment targets.
We hypothesize that, QST may provide us detailed information about corneal nerve function alterations and may correlate with morphological nerve changes detected by IVCM.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Stage I Neurotrophic Keratopathy | Experimental | Device: Quantitative Sensory TestClinical 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. |
| Stage II Neurotrophic Keratopathy | Experimental | Device: Quantitative Sensory TestClinical 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. |
| Dry Eye Disease | Experimental | Device: Quantitative Sensory TestSymptoms 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. |
| Healthy Individuals | Experimental | Device: Quantitative Sensory TestAbsence of any ocular symptoms, absence of surface findings (including corneal or conjunctival staining, corneal scar or surgical wound), and normal corneal sensation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Group 1: Stage I Neurotrophic Keratopathy (NK)
- Clinical findings of Stage I NK
- Decreased nerve density by IVCM
- Decreased corneal sensation
- Group 2: Stage II NK
Key exclusion criteria (11 listed)
- History of diabetes
- History of ocular surgery, corneal infection, or corneal injury within the last 3 months
- Systemic regular anti-inflammatory and/or steroid and/or immune-modulatory therapy in the last 3 months
- Active ocular allergies
- Any major psychiatric illness including bipolar, psychosis, obsessive-compulsive disorder and major depression
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quantitative Sensory TestQuantitative Sensory Test (Medoc Ltd, Israel), QST is a non-invasive neurophysiological method that refers to a group of procedures that assess the perceptual responses to systematically applied and quantifiable sensory stimuli (modalities including heat, cold and vibration) for the purpose of characterizing somatosensory function or dysfunction. For this test, subjects will be seated comfortably on a chair in a quiet room, or laying supine in a horizontal examination chair, with ambient temperature of 24-25◦ C. Medial upper eyelid; just below the supraorbital notch, nasolacrimal sac area; 4-5 mm medial to nasal cantus, and non-dominant forearm will be used as test sites. Patients will be instructed in detail of the nature of the test and the need to react attentively and promptly to change in temperatures. | Device | Dry Eye Disease, Healthy Individuals, Stage I Neurotrophic Keratopathy, Stage II Neurotrophic Keratopathy |
Primary outcome
Thermal stimulus response to QST on site of trigeminal nerve first branch, as assessed by cold detection threshold (CDT) and hot detection threshold (HDT)
Time frame: From visit 1 up to 4 weeks
Cold and heat sensation thresholds will be evaluated by placing a 16 mm x 16 mm probe over the skin on the site to be tested, and an average of 3 reading while be taken for each stimuli. Participants will receive successive ramps of gradually decreasing or increasing temperature, starting from a resting neutral temperature of 32°C. Participants will be instructed to press a response button when a thermal sensation (either cold or warm) is perceived.
Mechanical stimulus response to QST on site of trigeminal nerve first branch, as assessed by vibration detection threshold (VDT)
Time frame: From visit 1 up to 4 weeks
Vibration sensation threshold will be evaluated by placing a 16 mm x 16 mm probe over the skin on the site to be tested, and an average of 3 reading while be taken. Participants will receive successive ramps of gradually decreasing or increasing vibration, starting from. Participants will be instructed to press a response button when a mechanical sensation is perceived.
Differences in thermal stimulus pain threshold across the 4 study arms
Time frame: From visit 1 up to 4 weeks
Cold pain threshold (CPT) and heat pain threshold (HPT) will be measured by asking participants to press a response button when they first feel a pain or discomfort from probe on QST testing
Differences in mechanical stimulus pain threshold across the 4 study arms
Time frame: From visit 1 up to 4 weeks
Vibration pain threshold (VPT) will be measured by asking participants to press a response button when they first feel a pain or discomfort from vibration probe on QST testing
3 secondary outcomes
To correlate the QST responses with morphological changes of corneal nerves detected by IVCM
Time frame: From visit 1 up to 4 weeks
To correlate symptom severity as assessed by the Ocular Surface Disease Index (OSDI), to stimulus response across the 4 interventional arms.
Time frame: From visit 1 up to 4 weeks
To compare QST response differences between trigeminal nerve first branch and forearm in patients.
Time frame: From visit 1 up to 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pedram Hamrah, MD principal investigator
Tufts Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quantitative Sensory Test in people with Corneal Disease and Neuropathy, run by Tufts Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 8 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Thermal stimulus response to QST on site of trigeminal nerve first branch, as assessed by cold detection threshold (CDT) and hot detection threshold (HDT) (time frame: From visit 1 up to 4 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2026.