Registry of PHAcoemulsification for Cataract Surgery

NCT ID: NCT06659419

Last Updated: 2025-01-22

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 100000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-10-01
• Study Completion Date: 2025-07-31

Brief Summary

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.

Detailed Description

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.

Conditions

Cataract

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: OTHER

Eligibility Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Antoine BREZIN, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

Ophthalmology department - Cochin Hospital

Paris, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Antoine BREZIN, MD, PhD

Role: CONTACT

antoine.brezin@aphp.fr

01 58 41 22 01 ext. +33

Alice CAMARA

Role: CONTACT

alice.camara@aphp.fr

01 58 41 12 11 ext. +33

Facility Contacts

Antoine BREZIN, MD, PhD

Role: primary

antoine.brezin@aphp.fr

01 58 41 22 01 ext. +33

Other Identifiers

APHP240817

Identifier Type: -

Identifier Source: org_study_id