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

NCT ID: NCT04732351

Last Updated: 2026-01-15

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 5000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-05-05
• Study Completion Date: 2022-03-03

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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Active sentry

Cataract procedures conducted with the active Sentry handpiece

No interventions assigned to this group

Non-active sentry

Cataract procedures conducted with an handpiece different from the Active Sentry Handpiece

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

URC-CIC Paris Descartes Necker Cochin

OTHER

Sponsor Role: collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Antoine BREZIN, PhD & MD

Role: PRINCIPAL_INVESTIGATOR

Hopital Cochin, Ophthalmology, Paris

Locations

Ophtalmopôle, Hôpital Cochin

Paris, Île-de-France Region, France

Countries

France

References

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.

Reference Type: RESULT

PMID: 37973548 (View on PubMed)

Other Identifiers

57203277

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

APHP201099

Identifier Type: -

Identifier Source: org_study_id