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New custom lens aims to sharpen vision for those with tricky eye shapes

NCT ID NCT07294716

Disease control Sponsor: Johannes Kepler University of Linz Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study tests whether a custom-made lens implanted during cataract surgery can better correct vision in people with irregularly shaped corneas. Fifteen adults with significant astigmatism will receive the special lens. The goal is to reduce total astigmatism and improve visual outcomes beyond what standard lenses offer.

What this could mean

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

Active substance
customized toric intraocular lens (AMILens Individual)
What this could lead to
If successful, this could provide a new option for cataract patients with irregular corneas to achieve clearer vision without needing contact lenses after surgery.
What could go wrong
This is a small, early exploratory study with only 15 participants, so results may not apply to everyone. Custom lenses may not fully correct irregular astigmatism, and risks of cataract surgery still apply.

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 15 people

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

Started

Jan 2026

Expected to finish

Jun 2027

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

21 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 21 years or older * Scheduled cataract surgery * At least 1.75 D of total astigmatism in the CASIA2 measurement * At least 0.75 D of asymmetry or higher order irregularity within the 6mm zone of the real (total) index corneal refractive map of the CASIA2 measurements Exclusion Criteria: * Relevant central corneal scars * PEX, previous ocular surgery, severe trauma or any pathology that could lead to an unstable capsular bag * Combined surgery (cataract plus glaucoma/vitreoretinal/corneal surgery) * Postoperative best corrected distance visual acuity below 0.3 Snellen decimal * Pregnancy

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Conditions

The condition(s) this trial relates to.

astigmatism cataract irregular astigmatism

As listed by the trial registrant

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

Astigmatism Cataract and iol surgery Irregular astigmatism

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

  • Kepler University Clinic, Department for Ophthalmology and Optometry

    RECRUITING

    Linz, 4020, Austria

More trials for these conditions

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