Clinical trial NCT04732351: Evaluation of the Active Sentry System During Cataract Surgery With the Centurion Phacoemulsifier
Official title: Observational Multicenter Registry to Assess the Enefits of Active Sentry Handpiece During Cataract Surgery With the Centurion Phacoemulsifier (SASCA)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cataract Surgery
Keywords: Cataract surgery
phacoemulsification
Cumulated dissipated energy
Active Sentry
Centurion
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2021-02-01
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who will undergo a cataract surgery in routine

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.


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

Primary outcomes:
measure: Mean CDE (Cumulated Dissipated Energy)
timeFrame: The day of the cataract procedure
Secondary outcomes:
measure: Mean total procedure duration
timeFrame: The day of the cataract procedure
measure: Mean total Ultrasound time (US time)
timeFrame: The day of the procedure
measure: Mean procedure settings
timeFrame: The day of the procedure
measure: Mean BSS volume
timeFrame: The day of the procedure
measure: Frequency of adverse events
timeFrame: The day of the procedure
Other outcomes:
Locations:
city: Paris
country: France
facility: Ophtalmopôle, Hôpital Cochin
state: Île-de-France
Study officials:
affiliation: Hopital Cochin, Ophthalmology, Paris
name: Antoine BREZIN, PhD & MD
role: PRINCIPAL_INVESTIGATOR
References: