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New eye test could unlock secrets of ocular pain

NCT ID NCT05758753

Knowledge-focused Sponsor: Tufts Medical Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused This study
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at how well a new test called quantitative sensory testing (QST) can measure nerve function in the eye. Researchers will use heat, cold, and vibration to see how people with dry eye disease or corneal nerve damage respond. The goal is to better understand eye pain and nerve health, not to provide a treatment. About 108 adults will take part.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 108 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2023

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: Group 1: Stage I Neurotrophic Keratopathy (NK) 1. Clinical findings of Stage I NK 2. Decreased nerve density by IVCM 3. Decreased corneal sensation Group 2: Stage II NK 1. Clinical findings of Stage II NK 2. Decreased nerve density by IVCM 3. Decreased corneal sensation Group 3: Dry Eye Disease (DED) 1. Symptoms of DED at least 3 months 2. 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 3. Normal or mildly effected corneal sensation Group 4: Healthy Individuals 1. Absence of any ocular surface symptoms 2. Absence of ocular surface findings 3. Transparent and clear cornea 4. Normal corneal sensation Group 5: NCP 1. Presence of neuropathic symptoms AND 2. Symptoms out of proportion to clinical findings AND 3. Nerve abnormalities detected by in vivo confocal microscopy Exclusion Criteria: 1. History of diabetes 2. History of ocular surgery, corneal infection, or corneal injury within the last 3 months 3. Systemic regular anti-inflammatory and/or steroid and/or immune-modulatory therapy in the last 3 months 4. Active ocular allergies 5. Any major psychiatric illness including bipolar, psychosis, obsessive-compulsive disorder and major depression 6. Pregnancy 7. History of surgery within the last 3 months 8. History of , sarcoidosis, GVHD or collagen vascular disease 9. Allergic to benzalkonium chloride "BAK" (an eye-drop preservative) 10. Concurrent enrollment in other studies that in the opinion of the investigator will interfere with the results of this study 11. Non-English speakers

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Conditions

The condition(s) this trial relates to.

corneal disorder dry eye syndrome neurotrophic keratopathy peripheral neuropathy

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Corneal disease Dry eye disease Neuropathy Neurotrophic keratitis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Tufts Medical Center

    Boston, Massachusetts, 02111, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.