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NCT Number: NCT06659419

Registry of PHAcoemulsification for Cataract Surgery

Cataracts cause vision loss due to opacities in the lens. Cataract surgery is performed by emulsifying the nucleus of the lens. A phacoemulsifier is the machine used to deliver ultrasonic energy in the eye to fragment the lens and aspirate the debris.

In contrast to the large number of cataract procedures performed worldwide, there is surprisingly scarce data regarding the intraoperative parameters used during phacoemulsification. As new technologies are made available to surgeons, this impedes a large-scale analysis of the benefits of the advances in phacoemulsifiers. The investigators aim to establish a nationwide registry with a database of intraoperative data recorded during the cataract procedures performed with the Centurion phacoemulsifier.

The data collected would encompass all parameters recorded in the phacoemusifiers' logs, such as the energy delivered in the eye (longitudinal, torsional and other), US time, BSS volume, duration of the procedure, surgeon settings and others. The objective will be to capture data from at least 100,000 procedures/year.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Ophthalmology department - Cochin Hospital

Paris, 75014, France

Location status: Recruiting

Location contact

Antoine BREZIN, MD, PhD

CONTACT

[email protected]

01 58 41 22 01 ext. +33

About this study

A nationwide registry will be established with a database of intraoperative data recorded during the cataract procedures performed with the Centurion phacoemulsifiers. The following intraoperative parameters used during the cataract surgery will be recorded and analyzed:

Primary endpoint: Ultrasound time (US time)

Exploratory endpoints:

  • CDE : Cumulated dissipated Energy
  • Total surgery time
  • BBS volume
  • Torsional and longitudinal energy
  • IOP settings
  • Vacuum settings Procedures performed with the Active Sentry module - where a pressure sensor is built in the phacoemulsifier handpiece will be compared to other to procedures performed without this module.

Data will be collected and analyzed from Centurions cases log extracted from at least 200 Centurions installed in France. Parameter and settings will be retrospectively analyzed.

A direct extraction of data from the machines will be processed for the analyses. No patient demographic data will be recorded.

The objective will be to capture data from at least 100,000 procedures and to run data analyses on a nationwide scale.

The database will serve as a basis to assess the technological advances aimed at reducing the amount of energy delivered in the eye, the duration of ultrasound use and overall the duration of procedures.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All procedures recorded in Centurions (200 machines).

Exclusion criteria

  • Opposition of the center to data collection.
  • Complicated surgery (e.g. anterior vitrectomy) identified as such in the event log

Treatment and study plan

Primary outcomes

  1. Description of intraoperative parameters during cataract surgery when using Active Sentry

    Time frame: time of the surgery

    To describe intraoperative parameters during cataract surgery when using Active Sentry compared with other handpieces in a large registry comprising at least 200 centurions (>85 benefiting from the Active Sentry upgrade). Data will be collected and analyzed from event logs extracted from 200 Centurions installed in France.

    Parameters and settings will be analyzed retrospectively.

Study contacts

Contact information is provided by the study sponsor or research team.

Alice CAMARA

CONTACT

[email protected]

01 58 41 12 11 ext. +33

Antoine BREZIN, MD, PhD

CONTACT

[email protected]

01 58 41 22 01 ext. +33

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Acronym: ROPHACS

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 26, 2024
Registry last updated
Jan 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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