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

NCT06611670 | Not Yet Recruiting

• 1 other identifier: 2025-11959
• Study Type: interventional
• Target: 38
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Cataract; Cataract Surgery; Cataract Bilateral

Keywords

Active Sentry; cataract surgery; cataracts; High intra-ocular pressure; central corneal thickness; intraocular pressure; phacoemulsification; safety profile; physiological IOP

Outcome Measures

Primary Outcomes (1)

• 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).

  1 day postoperatively

Secondary Outcomes (5)

• Volume of balanced salt solution used during surgery

  During surgery

• Total ultrasound time and total aspiration time

  During surgery

• Endothelial cell loss (inner surface of the cornea)

  At month 1 and month 3 postoperatively.

• Central corneal thickness

  1 week, 1 month and 3 months postoperatively

• Corneal clarity

  Day 1, week 1, month 1 and month 3 postoperatively

Other Outcomes (7)

• Visual acuity

  Day 1, week 1, month 1, and month 3 postoperatively

• Low contrast evaluation

  Day 1, week 1, month 1, and month 3 postoperatively

• Intraocular pressure

  Day 1, week 1, month 1, and month 3 postoperatively

Study Arms (2)

Cataract surgery with Active Sentry

EXPERIMENTAL

Cataract surgery with low IOP values (32mmHg)

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

Procedure: Traditional cataract surgery

Interventions

Cataract surgery with Active Sentry DEVICE

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

Cataract surgery with Active Sentry

Traditional cataract surgery PROCEDURE

Cataract surgery performed with high intraocular pressures

High IOP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 22-26mm, refractive error between -5.00D to +5.00D and cylinder ≤ 3.00D, normal K values \<47.00D
• Axial eye length cannot vary by more than 0.4 mm between eyes of an individual patient
• Normal CCT range 540µm ± 50

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM): lead

Related Publications (2)

• 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.

  PMID: 19168897 BACKGROUND

• Vasavada 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.

  PMID: 20362850 BACKGROUND

MeSH Terms

Conditions

Cataract

Interventions

Cataract Extraction

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Refractive Surgical Procedures; Ophthalmologic Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Samir Jabbour, MD,CM,FRCSC

  Centre hospitalier de l'Université de Montréal (CHUM)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Samir Jabbour, MD,CM,FRCSC

CONTACT

514-890-8000; Samir.Jabbour.med@ssss.gouv.qc.ca

Marie-Catherine Tessier, M.Sc.

CONTACT

514 890-8000; marie-catherine.tessier.chum@ssss.gouv.qc.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ophthalmologist, Assistant clinical professor

Model Details: 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). 76 eyes of 38 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.

Study Record Dates

• First Submitted: September 22, 2024
• First Posted: September 25, 2024
• Study Start: October 1, 2024
• Primary Completion: February 1, 2025
• Study Completion: March 1, 2025
• Last Updated: September 25, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share