Could lower eye pressure during cataract surgery reduce corneal damage?
NCT ID NCT06611670
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
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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
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31 people
The number who actually took part.
- Started
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Jan 2025
- Finished
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Mar 2026
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide 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
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Centre Hospitalier de l'Université de Montréal
Montreal, Quebec, Canada
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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