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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04732351
Other study ID # APHP201099
Secondary ID 57203277
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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