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Completed

NCT Number: NCT06611670

Outcomes of High vs Physiological Intraocular Pressure During Cataract Surgery Using ACTIVE SENTRY

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier de l'Université de Montréal

Montreal, Quebec, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cataract surgery with Active Sentry

Device

Surgical instrument that detects changes in intraocular pressure and allows rapid feedback to stabilize pressure during cataract surgery.

Traditional cataract surgery

Procedure

Cataract surgery performed with high intraocular pressures

Primary outcomes

  1. 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).

Secondary outcomes

  1. Volume of balanced salt solution used during surgery

    Time frame: During surgery

    Volume of balanced salt solution as measured by the Active Sentry Centurion machine

  2. Total ultrasound time and total aspiration time

    Time frame: During surgery

    Total ultrasound time and total aspiration time as measured by the Active Sentry Centurion machine

  3. Endothelial cell loss (inner surface of the cornea)

    Time frame: At month 1 and month 3 postoperatively.

    Endothelial cell count measured by specular microscopy

  4. Central corneal thickness

    Time frame: 1 week, 1 month and 3 months 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. Corneal clarity

    Time frame: Day 1, week 1, month 1 and month 3 postoperatively

    Measured uring the Pentacam corneal densitometry

Other outcomes

  1. Visual acuity

    Time frame: Day 1, week 1, month 1, and month 3 postoperatively

    Evaluated using a Snellen chart

  2. Low contrast evaluation

    Time frame: Day 1, week 1, month 1, and month 3 postoperatively

    Evaluated using the CSV-1000 Contrast Sensitivity chart with glare

  3. Intraocular pressure

    Time frame: Day 1, week 1, month 1, and month 3 postoperatively

    Measured using the Goldmann Applanation Tonometer

  4. Cystoid macular edema

    Time frame: 1 month postoperatively

    Evaluated using the Macular Optical Coherence Tomography (OCT)

  5. Rate of reverse pupillary block

    Time frame: 1 day, 1 week, 1 month and 3 months postoperatively

    Evaluated using slit lamp examination

  6. Posterior capsular tear

    Time frame: During surgery

    Complication during cataract surgery

  7. Posterior capsular rupture

    Time frame: During surgery

    Complication during cataract surgery

Sponsors and collaborators

Lead sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Other

Registry information

Acronym: ACTIVESENTRY

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 25, 2024
Registry last updated
Jul 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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