Can a simple eyelid wipe make cataract surgery safer?
NCT ID NCT07418333
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
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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
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About 100 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Apr 2026
An estimate. Start dates often move.
- Expected to finish
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Nov 2026
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 85 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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.
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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