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Can a simple eyelid wipe make cataract surgery safer?

NCT ID NCT07418333

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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tests whether using EPD-09-25 eyelid wipes before and after cataract surgery can reduce bacteria on the eyelid and improve dry eye symptoms. One hundred adults scheduled for cataract surgery will either use the wipes twice daily for five weeks or receive no special eyelid hygiene. The goal is to see if cleaning the eyelid helps prevent infections and keeps the eye more comfortable after surgery.

What this could mean

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

Active substance
EPD-09-25 eyelid wipes (device)
What this could lead to
If effective, these wipes could become a standard part of cataract surgery care to lower infection risk and improve comfort.
What could go wrong
This is a small, early-stage trial with only 100 participants. The wipes may not significantly reduce bacteria or symptoms compared to no cleaning.

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 100 people

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

Expected to start

Apr 2026

An estimate. Start dates often move.

Expected to finish

Nov 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

18 to 85 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: 1. Male and female adults aged ≥ 18 and ≤ 85 years. 2. Clinical diagnosis of cataract scheduled for cataract surgery. 3. Provision of written informed consent as approved by the Ethics Committee (EC). Exclusion Criteria: 1. Patients with DED and MGD, before cataract surgery, confirmed at Visit 0 (screening and baseline). At least one of the following conditions (in the eye subjected to cataract surgery) must be met: * TBUT \< 10s * SPEED score \> 4 2. Recent (≤8 weeks) use or dose adjustment of systemic medications known to affect tear film or lacrimal section systemic antihistamines, antidepressant such as SSRI/SNRI/TCA, antiparkinsonian agents, anticholinergics, oral isotretinoin. 3. Active or uncontrolled ocular allergy (e.g. allergic conjunctivitis, keratoconjunctivitis) within 4 weeks prior to screening or requiring therapy during the study. 4. Ongoing ocular or systemic infectious (bacterial, viral or fungal) or suspected infection at screening. 5. Recurrent bacterial conjunctivitis (at least once a month in the last 6 months) 6. Any intraocular surgery within 12 months prior to screening or planned intraocular surgery during the study (other than the cataract procedure under study). 7. Acute (active at the screening and baseline visit) or Chronic (persistent) Conjunctival Disease (e.g., symptomatic pterygium, cicatricial conjunctivitis); conditions that may alter the ocular surface and influence the assessment of symptoms. 8. Eyelid surgery within the 6 months prior to study enrolment. 9. Congenital absence (genetic defect) of lacrimal or Meibomian glands or clinically significant obstruction of the lacrimal glands (blockage of the tear drainage system (e.g. nasolacrimal duct stenosis) which can cause excessive tearing or alter the distribution of the tear film. 10. History of ocular herpetic keratitis or active blepharitis, demodex infestation or ocular rosacea within 4 weeks prior to study enrolment. 11. History of autoimmune diseases requiring systemic immunosuppressive therapy. 12. Clinically significant eyelid malposition or mechanical abnormalities, in accordance with PI's clinical judgment. 13. History of corneal diseases (e.g., keratoconus, keratitis, keratoconjunctivitis, corneal dystrophies, permanent damage due to corneal ulcer) 14. History of corneal transplant in one or both eyes 15. Keratinization of the eyelid margin 16. History of Sjögren's syndrome 17. History of corneal trauma within 4 weeks prior to study enrolment. 18. Inability to self-administer study device or absence of a caregiver able to assist with administration medication. 19. Women of childbearing potential who are pregnant, breastfeeding, planning to become pregnant during the study, or not using adequate birth control methods to prevent pregnancy throughout the study. 20. Known hypersensitivity to any of the investigational device components (e.g. PQ-133, Gombo, Kolliphor, etc) or wipes materials. 21. Legally or mentally incapacitated participants are unable to provide written informed consent. 22. Participants are unable or unwilling to comply with scheduled visits, procedures, or protocol requirements. 23. Chronic use of topical ocular hypotensive medications (e.g., for glaucoma). 24. Patients undergoing intravitreal injections. 25. Recent use (≤4 weeks) of topical or systemic therapies for DED/MGD that could confound efficacy outcomes, including cyclosporine, lifitegrast, prolonged topical corticosteroids, autologous serum, or procedural treatments such as IPL, LipiFlow, or similar interventions within the past 3-6 months, or punctal plugs placed within 3 months. 26. Use of contact lenses within 2 weeks prior to screening or planned use during the study.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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