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New laser tool for cataract surgery under review

NCT ID NCT07362043

Knowledge-focused Sponsor: Helix Surgical 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 looks at a hand-held laser used during cataract surgery to see if it keeps the risk of capsule tears below 2%. Researchers will review medical records of 446 adults who had cataract surgery with this laser as part of their regular care. The goal is to confirm how safe and effective the laser is in real-world use.

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.

Participants

About 446 people

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

Started

Jan 2026

Expected to finish

Mar 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.

Who is studied

Adult patients eligible for cataract surgery

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: * Adult patients (age \> 18 years); * Diagnosed with cataract requiring surgery according to current guidelines; * Eligible to lens removal by phacoemulsification and replacement by a prosthetic lens under local anesthesia; * Who confirmed their non-opposition to data collection Exclusion Criteria: * Patient already operated with Rx for the first eye. * Any contra-indication to cataract surgery; * Patients with an ACD (Anterior Chamber Depth) less than 1.8mm and greater than 4.2mm; * Corneal disease or pathology that prevents corneal applanation or that may interfere with or hinder laser beam transmission; * Presence of blood or any other element that hinders the propagation of light between the epithelium and the anterior surface of the lens where the capsulotomy will be performed; * Weak pupil dilation or severely off-center pupil that prevents the iris from retracting adequately to the periphery (dilations \< 6.5mm in diameter are excluded); * Abnormal tilt of the lens (\> 7 degrees) ; * Significant preoperative ocular hypotonia or hypertonia; * Presence of an intra-corneal implant; * Active or unstabilized ocular surface disease including abnormal corneas (e.g., epithelial dystrophies,recurrent ulcers, infectious foci, conjunctivitis, severe dry syndromes); * History of lens disease or zonular instability; * Any perforating incision of the eyeball that may result in leakage during corneal applanation; * Presence of a limbal tumor obstacle that may interfere with stabilization of the device on the limbus: pterygium, limbal tumor, filter bubble, etc. * Patients under guardianship, trusteeship or deprived of liberty; * Patients unable to give their non-opposition for data collection for psychiatric, cognitive or linguistic reasons.

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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 surgery

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

    1 site. 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

  • Santé Atlantique

    RECRUITING

    Saint-Herblain, France

    Contact Email: •••••@•••••

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