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New lens aims to sharpen sight after cataract removal

NCT ID NCT07650201

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study tests a new artificial lens, called an intraocular lens (IOL), placed in the eye during cataract surgery. The lens is designed to replace the eye's natural lens and help restore vision. Researchers will measure how clearly participants see one year after surgery and check for any side effects. The study includes adults who need cataract surgery and aims to confirm the lens is safe and works well.

What this could mean

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

Active substance
KI-362-US1 (YP2.2VM) intraocular lens (IOL)
What this could lead to
If successful, this lens could offer a safe and effective option for restoring clear vision after cataract surgery.
What could go wrong
This is a single-arm study without a comparison group, so results may not prove superiority over existing lenses. Risks include typical post-surgery complications like infection or lens dislocation.

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 340 people

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

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Nov 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

22 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: * Are able and willing to provide written informed consent, attend all scheduled visits, and comply with all trial procedures and follow-up * Have a study eye with visually significant cataract for which phacoemulsification cataract extraction and posterior chamber IOL implantation is indicated * Meet all other inclusion criteria outlined in the clinical study protocol Exclusion Criteria: * Have serious systemic disease that could increase operative risk or conditions that can confound the surgical outcome * Within 30 days of the Screening Visit, use of systemic medications with significant ocular side effects or any medications that could confound the outcome or increase participant risk * Meet any other exclusion criteria outlined in the clinical study protocol

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Conditions

The condition(s) this trial relates to.

Aphakia, Postcataract cataract

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 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 ↗

  2. 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.

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