CataractACTIVESENTRYNCT06611670
Outcomes of High vs Physiological Intraocular Pressure During Cataract Surgery Using ACTIVE SENTRY
A study testing Cataract surgery with Active Sentry and Traditional cataract surgery in people with Cataract and Cataract Surgery, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
Trial summary
Cataract surgery is a widely performed procedure across the world that helps restore vision in many patients suffering from cataracts. Irrigation is an essential component of the surgery. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cataract, Cataract Surgery, Cataract Bilateral
- What is being tested?
- Cataract surgery with Active Sentry and Traditional cataract surgery
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jan 2025to 31 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Cataract surgery is a widely performed procedure across the world that helps restore vision in many patients suffering from cataracts. Irrigation is an essential component of the surgery. Fluid is constantly circulated to help regulate temperature as heat is generated with ultrasound energy, to minimize tissue trauma, and to create an intraocular pressure (IOP) sufficient to keep the anterior chamber (AC) stable. In parallel, aspiration brings the components of the cataract closer to the surgical instrument. A balance between irrigation and aspiration during surgery is essential to maintain stability in the AC. However, an ideal flow rate, which influences IOP during surgery, is yet to be determined. Most recent studies with Centurion Active Sentry show that there is similar efficiency between higher and lower IOP settings. Traditionally, high-flow rates have been used in advanced cataracts and are believed to make space in the AC. However, they are known to create fluid turbulence and are associated with risks of tissue damage, including cell loss in one of the cornea's layers. High IOP during surgery has also been shown to cause damage to the optic nerve as well as to the retina. Distorting and stretching the AC during phacoemulsification have also been associated with increased pain experienced by the patient. Comfort can be achieved by lowering pressure levels. Low-flow rates have a better safety profile, reduce IOP and pressure fluctuations while offering equal efficiency, including comparable surgical time. Using central corneal thickness (CCT) as an indicator of corneal trauma, it has been shown that patients that have had surgery with low-flow rates present no change in the CCT postoperatively as opposed to patients in the high-flow rates. As less fluid turbulence is created with low-flow rates, there is decreased risk of fragment contact with the cornea's inner surface, thus reducing cell loss. Alcon Laboratories, Inc. developed Active Fluidics which allows to stabilize intraocular pressure and prevent IOP fluctuations as well as IOP surges during surgery. It is now further equipped with the Active Sentry handpiece which is integrated to the surgical instrument and acts as a sensor to pressure variation. It allows rapid feedback to maintain a stable AC. Our research project aims to assess the outcomes following phacoemulsification done with physiological IOP with the help of the Active Sentry handpiece compared to traditional high IOP levels.
Read the detailed description
Cataract surgery is a widely performed procedure across the world that helps restore vision in many patients suffering from cataracts. The surgery has known many improvements across time and continues to do so. Irrigation is an essential component of the surgery. Fluid is constantly being circulated to help regulate temperature as heat is generated with the use of ultrasound energy, to minimize tissue trauma, and to create an intraocular pressure sufficient to keep the anterior chamber stable. In parallel, aspiration brings the components of the cataract closer to the surgical instrument. A balance between irrigation and aspiration during surgery is essential to maintain stability in the anterior chamber. However, an ideal flow rate, which influences intraocular pressure (IOP) during surgery, is yet to be determined. Most recent studies with Centurion Active Sentry (maintaining vacuum and aspiration rates the same) show that there is similar efficiency between higher and lower IOP settings. Traditionally, high-flow rates have been used in advanced cataracts and are believed to increase the space in the anterior chamber. However, they are known to create fluid turbulence and are associated with risks of tissue damage, including cell loss in the endothelial layer of the cornea. High intra-ocular pressure during surgery has also been shown to cause damage to the optic nerve as well as to the retina. Distorting and stretching the anterior chamber during phacoemulsification have also been associated with increased pain experienced by the patient. Comfort can be achieved by lowering pressure levels. Low-flow rates have a better safety profile, reduce IOP and pressure fluctuations while offering equal efficiency, including comparable surgical time. Using central corneal thickness (CCT) as an indicator of corneal trauma, it has been shown that patients that have had surgery with low-flow rates present no change in the CCT postoperatively while patients in the high-flow rates show signs of corneal damage as well as greater anterior segment inflammation. As less fluid turbulence is created with low-flow rates, there is decreased risk of fragment contact with the cornea's inner surface, thus reducing cell loss. Alcon Laboratories, Inc. developed Active Fluidics which allows to stabilize intraocular pressure and prevent IOP fluctuations as well as IOP surges during surgery. It is now further equipped with the Active Sentry handpiece which is integrated to the surgical instrument and acts as a sensor to pressure variation. It allows rapid feedback to maintain a stable anterior chamber. Our research project aims to assess the outcomes following phacoemulsification done with physiological IOP with the help of the Active Sentry handpiece compared to traditional high IOP levels.
- Conditions
- Cataract, Cataract Surgery, Cataract Bilateral
- Being tested
- Cataract surgery with Active Sentry, Traditional cataract surgery
- Keywords
- Active Sentry, cataract surgery, cataracts, High intra-ocular pressure, central corneal thickness, intraocular pressure, phacoemulsification, safety profile, physiological IOP
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cataract surgery with Active SentryDevice
Surgical instrument that detects changes in intraocular pressure and allows rapid feedback to stabilize pressure during cataract surgery.
Traditional cataract surgeryProcedure or surgery
Cataract surgery performed with high intraocular pressures
| Study group | Role | What they receive |
|---|---|---|
| Cataract surgery with Active Sentry | Experimental | Cataract surgery with low IOP values (32mmHg) Receives: Device: Cataract surgery with Active Sentry |
| High IOP | Active comparator | Cataract surgery with high IOP (60mmHg) which is the average pressure at which cataract surgery is being performed currently Receives: Procedure: Traditional cataract surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Central corneal thickness at 1 day postoperatively
Using central corneal thickness (CCT) as an indicator of corneal trauma, it has been shown that patients that have had surgery with low-flow rates present no change in the CCT postoperatively. CCT will be measured using a pachymetry (Normal CCT range 540µm ± 50).
Measured: 1 day postoperatively
Secondary outcomes (5)
Volume of balanced salt solution used during surgery
Volume of balanced salt solution as measured by the Active Sentry Centurion machine
Measured: During surgery
Total ultrasound time and total aspiration time
Total ultrasound time and total aspiration time as measured by the Active Sentry Centurion machine
Measured: During surgery
Endothelial cell loss (inner surface of the cornea)
Endothelial cell count measured by specular microscopy
Measured: At month 1 and month 3 postoperatively.
Central corneal thickness
Using central corneal thickness (CCT) as an indicator of corneal trauma, it has been shown that patients that have had surgery with low-flow rates present no change in the CCT postoperatively. CCT will be measured using a pachymetry (Normal CCT range 540µm ± 50).
Measured: 1 week, 1 month and 3 months postoperatively
Corneal clarity
Measured uring the Pentacam corneal densitometry
Measured: Day 1, week 1, month 1 and month 3 postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2024
- Study start1 Jan 2025
- Primary completion31 Mar 2026
- Study completion31 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for CataractStudies of the same condition, open and under way.
- More trials run by Centre hospitalier de l'Université de Montréal (CHUM)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Interventional single-masked pair-eye design clinical trial, single-center, single-surgeon. Eyes will be block-randomized as to which surgery they will receive first (high vs low IOP phacoemulsification). 62 eyes of 31 patients will be included in this study. For each patient, one eye will be randomized to receive phacoemulsification with high IOP (Group 1), and the other eye will receive phacoemulsification with physiological IOP (Group 2). This way, each patient will receive both treatments, one for each eye, which will allow us to do paired analyses.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Samir Jabbour, MD,CM,FRCSC, Principal investigator, Centre hospitalier de l'Université de Montréal (CHUM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06611670
- Sponsor's protocol ID
- 2025-11959
- Other IDs
- 2025
- Acronym
- ACTIVESENTRY
- Status last verified
- Aug 2026
- First submitted
- 22 Sep 2024
- Last updated
- 14 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhao Y, Li X, Tao A, Wang J, Lu F. Intraocular pressure and calculated diastolic ocular perfusion pressure during three simulated steps of phacoemulsification in vivo. Invest Ophthalmol Vis Sci. 2009 Jun;50(6):2927-31. doi: 10.1167/iovs.08-2996. Epub 2009 Jan 24.
PubMed 19168897Vasavada AR, Praveen MR, Vasavada VA, Vasavada VA, Raj SM, Asnani PK, Garg VS. Impact of high and low aspiration parameters on postoperative outcomes of phacoemulsification: randomized clinical trial. J Cataract Refract Surg. 2010 Apr;36(4):588-93. doi: 10.1016/j.jcrs.2009.11.009.
PubMed 20362850
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of High vs Physiological Intraocular Pressure During Cataract Surgery Using ACTIVE SENTRY
- ClinicalTrials.gov ID
- NCT06611670
- Acronym / sponsor ID
- ACTIVESENTRY / 2025-11959
- Conditions
- Cataract, Cataract Surgery, Cataract Bilateral
- Keywords
- Active Sentry, cataract surgery, cataracts, High intra-ocular pressure, central corneal thickness, intraocular pressure, phacoemulsification, safety profile
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 31 Mar 2026 (actual)
- Study completion
- 31 Mar 2026 (actual)
- First posted
- 25 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Cataract surgery is a widely performed procedure across the world that helps restore vision in many patients suffering from cataracts. Irrigation is an essential component of the surgery. Fluid is constantly circulated to help regulate temperature as heat is generated with ultrasound energy, to minimize tissue trauma, and to create an intraocular pressure (IOP) sufficient to keep the anterior chamber (AC) stable. In parallel, aspiration brings the components of the cataract closer to the surgical instrument. A balance between irrigation and aspiration during surgery is essential to maintain stability in the AC. However, an ideal flow rate, which influences IOP during surgery, is yet to be determined. Most recent studies with Centurion Active Sentry show that there is similar efficiency between higher and lower IOP settings. Traditionally, high-flow rates have been used in advanced cataracts and are believed to make space in the AC. However, they are known to create fluid turbulence and are associated with risks of tissue damage, including cell loss in one of the cornea's layers. High IOP during surgery has also been shown to cause damage to the optic nerve as well as to the retina. Distorting and stretching the AC during phacoemulsification have also been associated with increased pain experienced by the patient. Comfort can be achieved by lowering pressure levels. Low-flow rates have a better safety profile, reduce IOP and pressure fluctuations while offering equal efficiency, including comparable surgical time. Using central corneal thickness (CCT) as an indicator of corneal trauma, it has been shown that patients that have had surgery with low-flow rates present no change in the CCT postoperatively as opposed to patients in the high-flow rates. As less fluid turbulence is created with low-flow rates, there is decreased risk of fragment contact with the cornea's inner surface, thus reducing cell loss. Alcon Laboratories, Inc. developed Active Fluidics which allows to stabilize intraocular pressure and prevent IOP fluctuations as well as IOP surges during surgery. It is now further equipped with the Active Sentry handpiece which is integrated to the surgical instrument and acts as a sensor to pressure variation. It allows rapid feedback to maintain a stable AC. Our research project aims to assess the outcomes following phacoemulsification done with physiological IOP with the help of the Active Sentry handpiece compared to traditional high IOP levels.
Detailed description
Cataract surgery is a widely performed procedure across the world that helps restore vision in many patients suffering from cataracts. The surgery has known many improvements across time and continues to do so. Irrigation is an essential component of the surgery. Fluid is constantly being circulated to help regulate temperature as heat is generated with the use of ultrasound energy, to minimize tissue trauma, and to create an intraocular pressure sufficient to keep the anterior chamber stable. In parallel, aspiration brings the components of the cataract closer to the surgical instrument. A balance between irrigation and aspiration during surgery is essential to maintain stability in the anterior chamber. However, an ideal flow rate, which influences intraocular pressure (IOP) during surgery, is yet to be determined. Most recent studies with Centurion Active Sentry (maintaining vacuum and aspiration rates the same) show that there is similar efficiency between higher and lower IOP settings. Traditionally, high-flow rates have been used in advanced cataracts and are believed to increase the space in the anterior chamber. However, they are known to create fluid turbulence and are associated with risks of tissue damage, including cell loss in the endothelial layer of the cornea. High intra-ocular pressure during surgery has also been shown to cause damage to the optic nerve as well as to the retina. Distorting and stretching the anterior chamber during phacoemulsification have also been associated with increased pain experienced by the patient. Comfort can be achieved by lowering pressure levels. Low-flow rates have a better safety profile, reduce IOP and pressure fluctuations while offering equal efficiency, including comparable surgical time. Using central corneal thickness (CCT) as an indicator of corneal trauma, it has been shown that patients that have had surgery with low-flow rates present no change in the CCT postoperatively while patients in the high-flow rates show signs of corneal damage as well as greater anterior segment inflammation. As less fluid turbulence is created with low-flow rates, there is decreased risk of fragment contact with the cornea's inner surface, thus reducing cell loss. Alcon Laboratories, Inc. developed Active Fluidics which allows to stabilize intraocular pressure and prevent IOP fluctuations as well as IOP surges during surgery. It is now further equipped with the Active Sentry handpiece which is integrated to the surgical instrument and acts as a sensor to pressure variation. It allows rapid feedback to maintain a stable anterior chamber. Our research project aims to assess the outcomes following phacoemulsification done with physiological IOP with the help of the Active Sentry handpiece compared to traditional high IOP levels.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Interventional single-masked pair-eye design clinical trial, single-center, single-surgeon. Eyes will be block-randomized as to which surgery they will receive first (high vs low IOP phacoemulsification). 62 eyes of 31 patients will be included in this study. For each patient, one eye will be randomized to receive phacoemulsification with high IOP (Group 1), and the other eye will receive phacoemulsification with physiological IOP (Group 2). This way, each patient will receive both treatments, one for each eye, which will allow us to do paired analyses.
| Arm | Type | Receives |
|---|---|---|
| Cataract surgery with Active Sentry | Experimental | Device: Cataract surgery with Active SentryCataract surgery with low IOP values (32mmHg) |
| High IOP | Active comparator | Procedure: Traditional cataract surgeryCataract surgery with high IOP (60mmHg) which is the average pressure at which cataract surgery is being performed currently |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cataract surgery with Active SentrySurgical instrument that detects changes in intraocular pressure and allows rapid feedback to stabilize pressure during cataract surgery. | Device | Cataract surgery with Active Sentry |
| Traditional cataract surgeryCataract surgery performed with high intraocular pressures | Procedure or surgery | High IOP |
Primary outcome
Central corneal thickness at 1 day postoperatively
Time frame: 1 day postoperatively
Using central corneal thickness (CCT) as an indicator of corneal trauma, it has been shown that patients that have had surgery with low-flow rates present no change in the CCT postoperatively. CCT will be measured using a pachymetry (Normal CCT range 540µm ± 50).
5 secondary outcomes
Volume of balanced salt solution used during surgery
Time frame: During surgery
Total ultrasound time and total aspiration time
Time frame: During surgery
Endothelial cell loss (inner surface of the cornea)
Time frame: At month 1 and month 3 postoperatively.
Central corneal thickness
Time frame: 1 week, 1 month and 3 months postoperatively
Corneal clarity
Time frame: Day 1, week 1, month 1 and month 3 postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
- Background: PubMed 19168897Zhao Y, Li X, Tao A, Wang J, Lu F. Intraocular pressure and calculated diastolic ocular perfusion pressure during three simulated steps of phacoemulsification in vivo. Invest Ophthalmol Vis Sci. 2009 Jun;50(6):2927-31. doi: 10.1167/iovs.08-2996. Epub 2009 Jan 24.
- Background: PubMed 20362850Vasavada AR, Praveen MR, Vasavada VA, Vasavada VA, Raj SM, Asnani PK, Garg VS. Impact of high and low aspiration parameters on postoperative outcomes of phacoemulsification: randomized clinical trial. J Cataract Refract Surg. 2010 Apr;36(4):588-93. doi: 10.1016/j.jcrs.2009.11.009.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samir Jabbour, MD,CM,FRCSC principal investigator
Centre hospitalier de l'Université de Montréal (CHUM)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cataract surgery with Active Sentry and Traditional cataract surgery in people with Cataract and Cataract Surgery, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Central corneal thickness at 1 day postoperatively (time frame: 1 day postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06611670, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2026.