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

Cataract Surgery Clinical Trial

— SASCA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04732351
• Other study ID #: APHP201099
• Secondary ID: 57203277
• Status: Completed
• Start date: May 5, 2021
• Est. completion date: March 3, 2022

Study information

• Verified date: September 2021
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5000
• Est. completion date: March 3, 2022
• Est. primary completion date: March 3, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cataract
• Cataract Surgery

Locations

Country	Name	City	State
France	Ophtalmopôle, Hôpital Cochin	Paris	Île-de-France

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

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