Pinhole contact lens aims to sharpen sight for two eye conditions
NCT ID NCT07559188
First seen Jun 27, 2026 · Last updated Jul 02, 2026 · Updated 1 time
Summary
This early study tests a special contact lens that has a tiny pinhole built in. The idea is that the pinhole helps focus light better, improving vision for people with presbyopia (age-related blurry near vision) or keratoconus (a cone-shaped cornea). Sixteen adults will try the lens for a single session to see if it reduces blur and eye distortions. This is a very early test to see if the concept works.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- NOA lens type 2 (scleral contact lens with integrated pinhole aperture)
- What this could lead to
- If it works, this lens could offer a non-surgical way to improve near and distance vision for people with presbyopia or keratoconus.
- What could go wrong
- This is a very small, early proof-of-concept study with only 16 people. The lens is a prototype, and it may not work for everyone or cause discomfort.
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 16 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Oct 2026
An estimate. Start dates often move.
- Expected to finish
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Mar 2027
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 years and older
- 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: * Age ≥ 18y at time of informed consent. * Provide written Informed Consent. * Being diagnosed in both eyes with: * Keratoconus, without having presbyopia (Group A) OR: Emmetropic (+-0.5 D) presbyopia, without having corneal irregularities (Group B) * Cornea considered to be clinically stable at the discretion of the investigator (e.g. no recent cross linking performed, no current corneal sutures, no corneal sutures recently removed). * Willing to remove current contact lenses (any type) in both eyes for a minimum of 48 hours prior to every study visit. * Able to read Dutch. Exclusion Criteria: * Active ocular infection or inflammation, including infectious keratitis, infectious conjunctivitis or blepharitis with discharge. * Medical history (of ocular pathologies) that might lead to incomplete/incorrect eye surface scan OR wavefront aberrometry, at the discretion of the investigator. * Use of fluorescein in the eye, within 12 hours prior to the PentacamAXL Wave scan. * Contact lens refitting within one month prior to the screening PentacamAXL Wave scan (or planned refitting throughout the study), as this can significantly impact the corneal or scleral surface. * Use of hybrid contact lenses or corneal RGP contact lenses within 3 months prior to (or planned use during) study participation. * Having worn contact lenses (any type) within 48 hours prior to performing the screening Pentacam AXL Wave scan at visit 1. * Clinically significant acute non-infectious ocular surface abnormality, including active corneal abrasion, recent ocular surface trauma. * Severe ocular surface disease that prevents safe lens application, stable wear, or lens removal. * Severe corneal hypoesthesia or neurotrophic keratopathy which would impair perception of pain, foreign body sensation or delay symptom reporting. * Known hypersensitivity or allergy to the lens material or approved cleaning, disinfecting or filling solutions. * Active allergic eye disease, including active papillary or follicular conjunctivitis. * Systemic conditions known to impair corneal healing, such as uncontrolled autoimmune disease. * Glaucoma. * Central opacity and/or central corneal scarring and/or cataract. * History of low corneal endothelial cell count (\< 1500 cells/mm2) or endothelial pathologies, at the discretion of the investigator. * Aphakic and pseudophakic. * Severe meibomian gland dysfunction, at the discretion of the investigator. * Known vitreoretinal pathologies, at the discretion of the investigator. * Subjects needing eye drops every 2hrs. * Pregnant or breastfeeding woman. * History of other known ocular pathologies that might influence the measured endpoints of the study, at the discretion of the investigator.
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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 study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
2 sites in 2 countries. The list below names each one and where it is.
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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.
Contacts and locations
Show contact details
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Genom att skicka in godkänner du våra Användarvillkor
Study contacts
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Contact
Email: •••••@•••••
Locations
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University Hospital Antwerp (UZA)
Antwerp, Belgium
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Visser Contactlenzen Brunssum
Brunssum, Netherlands
Contact Email: •••••@•••••
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Shorter eye treatment put to the test against standard crosslinking
- Eye scans as a window to the body: study probes retinal imaging across diseases
- Shorter UV treatment for keratoconus put to the test
- Insulin eye drops put to the test for faster corneal healing
- Eye scans could spot hidden vision risk in down syndrome