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New lens aims to restore vision at all distances after cataract surgery

NCT ID NCT07696130

Disease control Sponsor: Pomeranian Medical University Szczecin 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 10, 2026 · Last updated Jul 10, 2026

Summary

This study tests a new type of lens, called the enVista Envy, implanted during cataract surgery. The lens is designed to help people see clearly at far, intermediate, and near distances, while reducing common side effects like glare and halos. Twenty adults with cataracts or presbyopia will receive the lens in both eyes and be followed for six months to measure vision quality, complications, and how quickly the brain adapts.

What this could mean

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

Active substance
enVista Envy trifocal intraocular lens
What this could lead to
If successful, this lens could help people see clearly at far, intermediate, and near distances after cataract surgery, reducing the need for glasses.
What could go wrong
This is a small, early study with only 20 participants, so results may not apply to everyone. Some people may still experience glare or halos.

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 20 people

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

Started

Feb 2026

Expected to finish

Feb 2029

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

50 to 75 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: * Bilateral cataract or refractive lens exchange candidates. * Presbyopia and/or hyperopia. * Preoperative corneal astigmatism less than 1.00 diopter (D). * Absence of ocular diseases other than cataract. * High motivation to achieve spectacle independence. * Patients willing to accept the possibility of mild photic phenomena, such as glare and halos. Exclusion Criteria: * Ocular Conditions: * Glaucoma. * Amblyopia. * Macular diseases (including macular degeneration and other macular pathology). * Angle kappa greater than 0.5 mm. * Dry eye disease. * Corneal disorders. * Pupil abnormalities. * Irregular astigmatism. * Ocular motility disorders or strabismus. * Pupil diameter \< 2.5 mm under photopic conditions or \> 6.0 mm under mesopic conditions. * Abnormalities of the capsular bag or zonular apparatus, including pseudoexfoliation syndrome (PEX). * Lifestyle Factors: * Patients with unrealistic expectations regarding postoperative visual outcomes. * Individuals whose professions require highly precise visual performance, such as pilots, professional drivers, architects, or similar occupations. * Patients satisfied with using spectacles for near vision. * Age greater than 75 years (due to potential difficulties with neuroadaptation to new visual conditions). * Psychological and Personality Factors: * Patients with psychiatric disorders that may interfere with study participation or outcome assessment. * Patients dissatisfied with progressive addition lenses (progressive spectacles). * Patients with dyslexia or a history of stroke. * Type A personality traits (perfectionists). * Patients will also be excluded if the calculated IOL power falls outside the available range of +6.00 D to +34.00 D or if they have a history of laser vision correction surgery.

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Conditions

The condition(s) this trial relates to.

cataract

As listed by the trial registrant

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

Cataract Cataract (post-operative cataract surgery follow-up)

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

  • II Department of Ophthalmology, Pomeranian Medical University

    RECRUITING

    Szczecin, Zachodnipomorskie, 70-111, Poland

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