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Tear iron levels may reveal dry eye severity

NCT ID NCT07363824

Knowledge-focused Sponsor: Shanghai Changzheng Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 looks at whether the amount of iron in tears is linked to how severe dry eye disease is. Researchers will collect tear samples from 52 people with and without dry eye and compare iron levels to standard eye tests and symptom scores. The goal is to find a new way to diagnose or understand dry eye better.

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 study could point toward a new way to diagnose or monitor dry eye disease using a simple tear test.
What could go wrong
This is a small, early observational study with only 52 participants. It does not test any treatment, so it may not lead to immediate changes in care.

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 52 people

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

Started

Feb 2026

Expected to finish

May 2029

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

Based on your study protocol, here is the description for the "Study Population Description" field: This single-center, cross-sectional study will recruit participants from the patient population and staff/community at the Ophthalmology Department of Shanghai Changzheng Hospital. The Dry Eye Disease (DED) group will consist of consecutive patients presenting to the clinic who are diagnosed with DED according to the 2024 Chinese Expert Consensus criteria. The healthy control group will be recruited through hospital staff volunteers and community advertisements. All participants will be enrolled during the specified study period from the single site.

Ages

18 to 70 years

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: * Aged between 18 and 70 years, inclusive. * Willing and able to provide written informed consent. Exclusion Criteria: * History or clinical suspicion of significant systemic conditions: hematologic diseases, severe systemic infections, malignancies (treated or untreated), or chronic hepatic/renal insufficiency. * Use of artificial tears or any topical eye drops within 2 hours prior to examination. * Active ocular allergy, infection, or severe blepharitis within the past 1 month. * Systemic or topical use of antibiotics, corticosteroids, NSAIDs, or immunosuppressants within the past 1 month. * History of contact lens wear within the past 1 month. * History of blood transfusion, ocular surgery, or significant ocular trauma within the past 6 months. * Women who are pregnant, breastfeeding, or postmenopausal women undergoing hormone replacement therapy. * Known hypersensitivity to fluorescein sodium.

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Conditions

The condition(s) this trial relates to.

dry eye syndrome

As listed by the trial registrant

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

Dry eye disease IRON

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

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    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

  • Changzheng Hospital

    RECRUITING

    Shanghai, China

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