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Pinhole contact lens aims to sharpen sight for two eye conditions

NCT ID NCT07559188

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 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

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 16 people

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

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Mar 2027

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 years and older

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: * 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.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    2 sites in 2 countries. The list below names each one and where it is.

  3. 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 ↗

  4. 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

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • University Hospital Antwerp (UZA)

    Antwerp, Belgium

  • Visser Contactlenzen Brunssum

    Brunssum, Netherlands

    Contact Email: •••••@•••••

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