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

Completed

• Conditions: Cataract Surgery

• Registration Number: NCT04732351
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-01-29
• Study First Submitted QC: 2021-01-29
• Study First Posted: 2021-02-01
• Study Start: 2021-05-05
• Status Verified: 2021-09
• Primary Completion: 2022-03-03
• Study Completion: 2022-03-03
• Last Update Submitted: 2022-07-07
• Last Update Posted: 2022-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Ophtalmopôle, Hôpital Cochin; 🇫🇷 Paris, Île-de-France, France