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Could lower eye pressure during cataract surgery reduce corneal damage?

NCT ID NCT06611670

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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 01, 2026 · Last updated Aug 14, 2026 · Updated 2 times

Summary

This study investigates whether using a lower, more natural eye pressure during cataract surgery reduces trauma to the cornea compared to traditional high-pressure methods. The Active Sentry device helps maintain stable pressure by sensing changes in the eye. Researchers will measure corneal thickness after surgery as an indicator of damage, and also track fluid use and surgery time. The study includes adults with similar cataracts in both eyes who have not had prior eye surgery.

What this could mean

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

Active substance
Active Sentry device
What this could lead to
If successful, this could lead to safer cataract surgery with less damage to the cornea and optic nerve.
What could go wrong
This is a small, early-stage study with 31 participants, so results may not apply to all patients. The benefits of lower pressure may not outweigh surgical efficiency.

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

31 people

The number who actually took part.

Started

Jan 2025

Finished

Mar 2026

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

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * No prior ocular surgery including corneal refractive surgery * Bilateral visually significant cataract, similar in density (LOCS III grade 2+), undergoing uncomplicated cataract surgery * Equal dilated pupil size ≥6mm, no use of pupil expansion devices * Axial length 21-26mm, refractive error between -8.00D to +6.00D and cylinder ≤ 4.50D, normal K values \<48.00D * Normal CCT range 540µm ± 50 Exclusion Criteria: * History of corneal disease or dystrophies * Media opacification for reasons other than cataract * Compromised zonular integrity or stability. * Retinal and retinal vascular pathologies, age-related macular degeneration * Glaucoma * Patients with uncontrolled systematic diseases, including hypertension, diabetes, systemic cardiovascular diseases, and hematological diseases.

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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.

Contacts and locations

Locations

  • Centre Hospitalier de l'Université de Montréal

    Montreal, Quebec, Canada

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