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Robot arm takes on cataracts: early trial tests precision surgery

NCT ID NCT06990074

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early study is testing a robot-assisted system for cataract surgery in 30 adults aged 40 to 75. The robot is designed to help surgeons be more precise and improve safety compared to standard surgery. The main goal is to check for any eye-related side effects. If it works well, it could make cataract surgery even safer.

What this could mean

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

Active substance
robot-assisted surgical system
What this could lead to
If successful, this could lead to a safer, more precise way to perform cataract surgery, potentially reducing complications and improving recovery.
What could go wrong
This is a very early, small study (30 people) focused on safety, not effectiveness. The robot system may not work better than standard surgery, and unexpected side effects are possible.

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 30 people

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

Started

Sep 2025

Expected to finish

Oct 2026

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

40 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: * Male or female, between 40 and 75 (inclusive) years of age (measured at baseline) * A slit-lamp diagnosis of uncomplicated, age-related visually significant cataract that is not posterior polar or congenital * Eligible to undergo cataract extraction by phacoemulsification with intraocular lens (IOL) implantation * Able and willing to comply with all study procedures * Able to return for scheduled follow-up examinations * Willing to adhere to the prescribed medication regimen (to prevent inflammation and infection) * Provision of signed and dated informed consent form Exclusion Criteria: * Contraindication to general anesthesia * Posterior polar or congenital cataract * Previous history of vitrectomy, corneal, refractive, or cataract surgery * Concurrent participation in another ophthalmological clinical study * Allergies to any medications required in surgery, pre- and post-operative treatment * Diagnosis of corneal disease or pathology that precludestransmission of optical coherence tomography (OCT) laser wavelength (e.g., corneal opacity), distorts OCT laser light (e.g., corneal scarring or history of radial keratotomy), or compromises engagement of the patient interface (e.g., megalocornea or pterygium), in the opinion of the Investigator * History of poor pupil dilation, demonstration of poor reaction to pupil-dilation drugs (minimum 7 mm dilation should be targeted for study), diagnosis of a pupillary defect that precludes the iris from adequate peripheral retraction, and/or diagnosis of floppy iris syndrome or iris dyscoria * Current or prior use of concomitant medications known to cause floppy iris syndrome (e.g., alpha-blockers, such as Flomax) * Compromised cornea (e.g., Fuchs endothelial dystrophy) * History of lens or zonular instability * Immunocompromised or diagnosis of ophthalmic disease: ocular herpes zoster or simplex, lupus, collagenosis or other acute or chronic illnesses that increase the risk to the subject or confounds the outcomes of this study, in the opinion of the Investigator * Developmental disability or cognitive impairment that would make informed consent and the assessment of visual acuity impossible, in the opinion of the Investigator * History of significant ocular trauma * History of iritis or uveitis * Pregnant women, as confirmed via urine pregnancy test for women of child-bearing age at screening

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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 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

  • Clinica Quesada SA de CV

    RECRUITING

    San Salvador, San Salvador Department, El Salvador