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New cataract lens aims for sharper sight

NCT ID NCT07471295

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 23, 2026 · Updated 2 times

Summary

This study tests a special lens used during cataract surgery to see how well it improves vision. About 130 adults with cataracts will get the lens and have their eyesight checked afterward. The goal is to make sure the lens is safe and helps people see more clearly.

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

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 130 people

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

Started

Jul 2026

Expected to finish

Feb 2028

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: * Aged 18 years or older; * Patients willing, able, and with sufficient cognitive awareness to comply with examination procedures and schedule for follow-up visits; * Patients with clinically significant age-related cataract (cataract grades of 1, 2, 3 on the LOCSIII scale, but otherwise healthy, requiring surgical treatment, and scheduled for unilateral or bilateral phacoemulsification or Femtosecond-Laser-Assisted cataract surgery; * Patients with existing regular corneal astigmatism of minimum 0.75 D in at least the first eye to be operated. * Signed informed consent form; * Corrected distance visual acuity projected to be better than 0.2 logMAR after the cataract surgery, as determined by Investigator's medical judgment; * Calculated IOL power within the range of the investigational IOL; SE +18.0 D to +28.0 D (0.5 D Steps), and between a Cylinder range of +1.0 D to +2.5 D (0.5 D Steps); * Dilated pupil size large enough to visualize TIOL axis markings postoperatively; at least 5.5mm; * Clear intraocular media other than cataract. Exclusion Criteria: * Previous intraocular or corneal surgery in either eye that might confound the outcome of the study or increase the risk to the subject; * Keratometric astigmatism (assessed by IOL Master) of minimum 0.75 D in the first eye * Traumatic cataract; * Pregnancy or lactation; * Concurrent participation in another drug or device investigation within the last 30 days; * Irregular astigmatism; * Instability of keratometry or biometry measurements; * Subjects wearing contact lenses as standard vision aid; * Abnormal pupil; * Any anterior segment pathology that could significantly affect outcomes (e.g. chronic or recurrent uveitis, iritis, aniridia, rubeosis iridis, etc.); * History of concurrent intraocular inflammation; * Abnormal corneal findings in either eye (e.g. keratoconus, pellucid marginal degeneration, or clinically significant corneal membrane dystrophies); * History of any clinically significant retinal or ocular pathology or ocular diagnosis (e.g. diabetic retinopathy, ischemic diseases, macular degeneration, retinal detachment, optic neuropathy optic nerve atrophy, amblyopia, strabismus, microphthalmus, epiretinal membrane, Choroidal hemorrhage etc.) in the study eyes that could alter or limit final postoperative visual prognosis; * Pseudoexfoliation syndrome (according to investigator judgement); * Uncontrolled glaucoma or IOP higher than 24mmHg under ocular hypertension treatment; * All kind of infections (acute ocular disease, external / internal infection, systemic infection); * Monophthalmic patient; * Patients, who are unable to fixate for a longer time, e.g. strabismus, nystagmus, Parkinson disease * Patient expected to require retinal laser treatment before the end of the last follow-up examination; * Patient expected to require refractive laser treatment / refractive laser touch-up before the end of the last follow-up examination; * Patients who may be reasonably expected to require a secondary surgical intervention at any time during the investigation (other than Nd:YAG capsulotomy) * In case of both eyes included in this trial: Patients who need to undergo surgery on both eyes on the same day

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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

    6 sites in 4 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

Locations

  • Ayrshire Eye Clinic

    NOT_YET_RECRUITING

    Ayr, Ayrshire, KA7 2SP, United Kingdom

    Contact Email: •••••@•••••

  • Ofatlivist Alicante

    RECRUITING

    Alicante, 03001, Spain

  • Oční Centrum Praha

    RECRUITING

    Prague, Czechia

  • Oční klinikaO

    RECRUITING

    Prague, Prague, 18100, Czechia

  • PVK Precise Vision GmbH

    NOT_YET_RECRUITING

    Rheine, 48429, Germany

  • Universitätsklinikum Heidelberg

    NOT_YET_RECRUITING

    Heidelberg, 69120, Germany

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