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

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ClinicalTrials.gov Identifier: NCT04732351
Recruitment Status : Recruiting
First Posted : February 1, 2021
Last Update Posted : October 8, 2021
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Study Description
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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.


Condition or disease
Cataract Surgery

Study Design
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Study Type : Observational
Estimated Enrollment : 5000 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Observational Multicenter Registry to Assess the Enefits of Active Sentry Handpiece During Cataract Surgery With the Centurion Phacoemulsifier (SASCA)
Actual Study Start Date : May 5, 2021
Estimated Primary Completion Date : May 2022
Estimated Study Completion Date : May 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

Groups and Cohorts
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Group/Cohort
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


Outcome Measures
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Primary Outcome Measures :
  1. Mean CDE (Cumulated Dissipated Energy) [ Time Frame: The day of the cataract procedure ]
    Mean CDE measured by the phacoemulsifier in different groups according to baseline patients and/or eyes characteristics (nuclear cataract grading etc...)


Secondary Outcome Measures :
  1. Mean total procedure duration [ Time Frame: The day of the cataract procedure ]
    Mean total duration of each procedure in different groups

  2. Mean total Ultrasound time (US time) [ Time Frame: The day of the procedure ]
    Mean total Ultrasound time (US time) in different groups

  3. Mean procedure settings [ Time Frame: The day of the procedure ]
    Mean procedure settings : infusion pressure, aspiration flow and vacuum levels

  4. Mean BSS volume [ Time Frame: The day of the procedure ]
  5. Frequency of adverse events [ Time Frame: The day of the procedure ]
    Mean frequency of adverse events during procedures, including posterior capsule ruptures


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who will undergo a cataract surgery in routine
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04732351


Contacts
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Contact: Antoine BREZIN, PhD & MD +33158412201 antoine.brezin@aphp.fr
Contact: Guillaume MASSON, MSc +33158413478 guillaume.masson@aphp.fr

Locations
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France
Ophtalmopôle, Hôpital Cochin Recruiting
Paris, Île-de-France, France, 75014
Contact: Guillaume Masson, MSc    +33158413478    guillaume.masson@aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Antoine BREZIN, PhD & MD Hopital Cochin, Ophthalmology, Paris
More Information
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT04732351    
Other Study ID Numbers: APHP201099
57203277 ( Other Grant/Funding Number: Alcon EMA IIT )
First Posted: February 1, 2021    Key Record Dates
Last Update Posted: October 8, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Cataract surgery
phacoemulsification
Cumulated dissipated energy
Active Sentry
Centurion
Additional relevant MeSH terms:
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Cataract
Lens Diseases
Eye Diseases