Evaluation of the Active Sentry System During Cataract Surgery With the Centurion Phacoemulsifier (SASCA)

Observational Multicenter Registry to Assess the Enefits of Active Sentry Handpiece During Cataract Surgery With the Centurion Phacoemulsifier (SASCA)

Each new generation of phacoemulsification system has aimed to optimize the control of fluidics and the delivery of energy during phacoemulsification. Nicoli CM et al., (J Cataract Refract Surg 2016;42:157-162) suggested a better anterior chamber stability when using an active fluidics system. Malik PK et al., (Eye and Vision 2017;4:22) showed that using an IOP based phacoemulsification system in association with the use of an Intrepid balanced tip provides a reduction in CDE (Cumulated Dissipated Energy and EFU (Estimated Fluid Usage). It has also been shown that a lower CDE provides obvious benefits: less endothelium cells damages and lower complication rates (Mady MA et al., Clin.Ophthalmol. 2012; 6:503-10).

The latest technologies, i.e. the Active Sentry Handpiece and Hybrid tips, have been introduced to further improve the safety of phacoemulsification. The Active Sentry system has moved pressure sensors closer to the operated eye, hence further reducing the risk of surge during procedures. (Thorne A et al. Phacoemulsifier occlusion break surge volume reduction, J Cataract Refract Surg. 2018;44:1491-1496). The Hybrid tips have been designed to prevent posterior capsule rupture in the event of contact with the capsule.

This new technology allows phacoemulsification procedures under reduced infusion pressures and a "high-vacuum - low energy" strategy which may lead to a safer procedure.

Data from this study will try to demonstrate that cataract surgeries with Active Sentry will need less CDE and therefore may be safer, due to the surge effects decrease. This CDE parameter will be analysed according to differents subgroups: Presence of hybrid tip or balanced tip, cataract score based on the WHO nuclear grading recommendation (Thylefors B et al., (2002) The WHO Cataract Grading Group, Ophthalmic Epidemiology, 9:2, 83-95) The recent experiences conducted in real world condition in different sites have suggested that Centurion with AS was able to improved settings: maximum vacuum and UltraSound (US) time reduction and as a consequence a 20 to 30% CDE reduction.

Study Overview

• Status: Completed
• Conditions: Cataract Surgery

• Study Type: Observational
• Enrollment (Actual): 5000

Contacts and Locations

Study Locations

• France
  • Île-de-France
    • Paris, Île-de-France, France, 75014
      • Ophtalmopôle, Hôpital Cochin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients who will undergo a cataract surgery in routine

Description

Inclusion Criteria:

• All consecutive patients undergoing unilateral or bilateral cataract surgery with the Centurion phacoemulsifier, with the ability to give informed consent.
• Patients will undergo the cataract surgery with or without the Active Sentry module and with or without hybrid tip according to centers practice.
• Patients will undergo a cataract scoring (nuclear grade 1 to 3) prior surgery as described in the WHO recommendation:

Exclusion Criteria:

• Patients with :
• pupil dilation <5mm
• zonular defects
• corneal opacities

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Active sentry; Cataract procedures conducted with the active Sentry handpiece
Non-active sentry; Cataract procedures conducted with an handpiece different from the Active Sentry Handpiece

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean CDE (Cumulated Dissipated Energy)	Mean CDE measured by the phacoemulsifier in different groups according to baseline patients and/or eyes characteristics (nuclear cataract grading etc...)	The day of the cataract procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean total procedure duration	Mean total duration of each procedure in different groups	The day of the cataract procedure
Mean total Ultrasound time (US time)	Mean total Ultrasound time (US time) in different groups	The day of the procedure
Mean procedure settings	Mean procedure settings : infusion pressure, aspiration flow and vacuum levels	The day of the procedure
Mean BSS volume		The day of the procedure
Frequency of adverse events	Mean frequency of adverse events during procedures, including posterior capsule ruptures	The day of the procedure

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Antoine BREZIN, PhD & MD, Hopital Cochin, Ophthalmology, Paris

Study record dates

Study Major Dates

• Study Start (Actual): May 5, 2021
• Primary Completion (Actual): March 3, 2022
• Study Completion (Actual): March 3, 2022

Study Registration Dates

• First Submitted: January 29, 2021
• First Submitted That Met QC Criteria: January 29, 2021
• First Posted (Actual): February 1, 2021

Study Record Updates

• Last Update Posted (Actual): July 8, 2022
• Last Update Submitted That Met QC Criteria: July 7, 2022
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Cataract surgery; phacoemulsification; Cumulated dissipated energy; Active Sentry; Centurion
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: APHP201099; 57203277 (Other Grant/Funding Number: Alcon EMA IIT)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No