Actively Recruiting

All Genders
ID06659419

Registry of Phacoemulsification Parameters for Cataract Surgery Using the Centurion Machine A Nationwide Observational Study

Led by Assistance Publique - Hôpitaux de Paris · Updated on 2025-01-22

100000

Participants Needed

1

Research Sites

39 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Cataracts cause vision loss due to clouding of the eye's lens, and cataract surgery involves breaking up and removing this cloudy lens. Researchers are establishing a nationwide registry to collect detailed data from cataract surgeries performed using the Centurion phacoemulsifier, a device that delivers ultrasonic energy to fragment and remove the lens. Despite the high number of cataract surgeries worldwide, there is little data on the surgical parameters used, so this study aims to analyze this information on a large scale. The study will gather intraoperative data from the Centurion devices installed in at least 200 centers in France, recording parameters such as ultrasound time, energy delivered in different forms, volume of fluid used, surgery duration, and machine settings like vacuum and pressure. Procedures performed with the Active Sentry module, which includes a built-in pressure sensor, will be compared with those done without this module. Data will be extracted directly from the devices' logs and analyzed retrospectively. Participants will not be directly involved as no patient demographic data will be collected; instead, the study focuses on machine-recorded surgical data from at least 100,000 cataract procedures annually. The main outcome measured is the ultrasound time during surgery, with exploratory outcomes including various energy amounts, surgery time, fluid volume, and device settings. This data will help assess technological improvements aimed at reducing energy use and procedure length during cataract surgeries.

CONDITIONS

Official Title

Registry of PHAcoemulsification for Cataract Surgery

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • All cataract surgery procedures recorded using Centurion phacoemulsifier machines (200 machines included)
Not Eligible

You will not qualify if you...

  • Centers that do not consent to data collection
  • Surgeries identified as complicated, such as those requiring anterior vitrectomy, in the event log

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Ophthalmology department - Cochin Hospital

Paris, France, 75014

Actively Recruiting

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Research Team

A

Antoine BREZIN, MD, PhD

A

Alice CAMARA

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

Frequently Asked Questions

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