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

NCT04732351 | Completed

• 2 other identifiers: APHP20109957203277
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Cataract Surgery

Keywords

Cataract surgery; phacoemulsification; Cumulated dissipated energy; Active Sentry; Centurion

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Mean total procedure duration

  The day of the cataract procedure

• Mean total Ultrasound time (US time)

  The day of the procedure

• Mean procedure settings

  The day of the procedure

• Mean BSS volume

  The day of the procedure

• Frequency of adverse events

  The day of the procedure

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who will undergo a cataract surgery in routine

You may qualify if:

• 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:

You may not qualify if:

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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (1)

Ophtalmopôle, Hôpital Cochin

Paris, Île-de-France Region, 75014, France

Location

Related Publications (1)

• Brezin AP, Monnet D, Lignereux F, Rozot P, Jilet L, Abdoul H. Impact of a handpiece with a built-in fluidics pressure sensor on phacoemulsification: a multicentre prospective comparative study. BMJ Open Ophthalmol. 2023 Nov;8(1):e001431. doi: 10.1136/bmjophth-2023-001431.

  PMID: 37973548 RESULT

Study Officials

• Antoine BREZIN, PhD & MD

  Hopital Cochin, Ophthalmology, Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2021
• First Posted: February 1, 2021
• Study Start: May 5, 2021
• Primary Completion: March 3, 2022
• Study Completion: March 3, 2022
• Last Updated: January 15, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)