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Eye scan could spot hidden nerve pain in dry eye sufferers

NCT ID NCT05653921

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is testing whether a special microscope (in vivo confocal microscopy) can reliably detect tiny nerve growths called microneuromas in the cornea, which may be a sign of neuropathic corneal pain. Researchers will scan the eyes of 438 adults with dry eye or ocular pain to see if the presence of microneuromas matches their symptoms. The goal is to validate this imaging technique as a diagnostic tool, not to test a treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could provide a reliable way to diagnose neuropathic corneal pain using a simple eye scan, leading to better treatment decisions.
What could go wrong
The study is currently suspended, and it only aims to validate a diagnostic tool, not test a treatment. The biomarker may not prove reliable in all patients.

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.

Participants

About 438 people

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

Started

Dec 2022

Expected to finish

Oct 2026

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.

Who is studied

We will not be limiting the inclusion of the NCP or DED groups for this study. We will be recruiting from two Cornea Clinics in diverse large cities of Boston and Philadelphia. Thus, the sample collected from this group is expected to be representative of the population for each of these groups. We will be limiting inclusion of the control group to those age and sex matched controls as described above. This will allow for the conclusions drawn from this study to be more applicable in clinical practice. Without an age and sex matched control group, one could attribute differences in IVCM to these two variables instead of the disease(s).

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: All Subjects: 1. 18 years of age or older 2. Ability to consent 3. Best corrected visual acuity of 20/40 or better in each eye Dry Eye Disease Group: 1. Chief complaint is ocular surface discomfort or dry eye disease, but subject reports no ocular pain on OPAS questionnaire 2. Symptoms lasting at least 3 months 3. Presence of at least two of the following within the same eye: 1. Anesthetized Schirmer score =/\< 10mm 2. Corneal staining of \>3/15 based on NEI scale 3. Tear break up time \< 10 seconds Neuropathic Corneal Pain Group: 1. Chief complain is ocular surface discomfort or dry eye disease 2. Symptoms lasting at least 3 months 3. All of the following in both eyes: 1. Corneal staining of less than or equal to 3/15 based on NEI scale 2. Tear break up time =/\> 10 seconds 4. Must have at least 25% peripheral pain 5. Subject reported discomfort prior to drop response testing of at least 3 out of 10 Control Group: 1. No symptoms of ocular surface discomfort or dry eye disease 2. All of the following in both eyes 1. Anesthetized Schirmer score \> 10 mm 2. Corneal staining of less than or equal to 3/15 based on NEI scale 3. Tear break up time \> 10 seconds 3. The same sex and within 5 years of age of a patient within the NCP group. Exclusion Criteria: 1. Pregnant or nursing 2. Irregular corneal disease 3. Ocular surgery in the past 3 months 4. Ocular infection in the past 3 months 5. Active ocular allergies 6. Participation in a study that could potentially impact the IVCM in the opinion of the investigator 7. Current use of corneal nerve regeneration therapy that has been on-going for 3 months or more. 8. For NCP group only, patients for whom their pain and symptoms can be attributed to other causes in the opinion of the investigator

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Conditions

The condition(s) this trial relates to.

corneal disorder dry eye syndrome

As listed by the trial registrant

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

Corneal disease Dry eye syndromes

How to take part

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

  1. The places running it

    2 sites. 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

  • Scheie Eye Institute, University of Pennsylvania

    Philadelphia, Pennsylvania, 19104, United States

  • Tufts Medical Center

    Boston, Massachusetts, 02111, United States

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