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New lens aims to sharpen sight after dual eye surgery

NCT ID NCT07441616

Symptom relief Sponsor: Universitair Ziekenhuis Brussel Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Aug 26, 2026 · Updated 3 times

Summary

This study will test a new type of artificial lens, called the PureSee IOL, in 10 people who need surgery for both cataracts and a cornea condition called Fuchs dystrophy. The goal is to see if this lens helps patients see well at different distances and reduces their need for glasses after surgery. Researchers will measure vision sharpness, contrast sensitivity, and patient satisfaction over six months.

What this could mean

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

Active substance
PureSee™ extended range of vision intraocular lens (IOL)
What this could lead to
If successful, this lens could help people who need both cataract and cornea surgery see better at multiple distances and rely less on glasses.
What could go wrong
This is a very small feasibility study with only 10 participants and no comparison group. The results may not apply to everyone, and the lens may not perform as hoped.

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 10 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

Sep 2028

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.

Ages

40 to 90 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: * Patients with bilateral cataract grade greater than II, according to the Lens Opacities Classification System III (LOCS III) , combined with FECD displaying clinical or subclinical corneal edema or displaying visual disturbing guttae with at least Krachmer grade 3 * Patients aged between 40 and 90 years * Capacity to read and to understand the study information and to provide informed consent, as well as Patient Reported Spectacle Independence Questionnaire (PRSIQ) and Patient Reported Visual Symptom Questionnaire (PRVSQ) * Patients willing and capable to attend the 6-month follow-up appointment Exclusion Criteria: * history of ocular surgery * corneal scars * macular disease revealed by pre-surgical macular Optical Coherence Tomography (OCT), * opticopathy * glaucoma with reduced sensitivity of visual field * uveitis * amblyopia * axial length \<22mm or \>25mm, * scotopic pupil size \>5mm, * central corneal thickness \>700microns, * corneal astigmatism \>1 diopters (D) on biometry * irregular astigmatism (RMS HOA 3mm pupil \>0.3) * angle kappa \>0.3mm ((chord µ measured with Pentacam HR; Oculus, Wetzlar, Germany)

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Conditions

The condition(s) this trial relates to.

cataract Fuchs' endothelial dystrophy

As listed by the trial registrant

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

Cataract Fuchs endothelial corneal dystrophy

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

  • University Hospital Leuven

    Leuven, 3000, Belgium

More trials for these conditions

Other studies related to the condition(s) this trial covers.