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Registry of PHAcoemulsification for Cataract Surgery

Registry of PHAcoemulsification for Cataract Surgery

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06659419
Acronym
ROPHACS
Enrollment
100000
Registered
2024-10-26
Start date
2024-10-01
Completion date
2025-07-31
Last updated
2025-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cataract

Keywords

Cataract, Surgery, Phacoemulsification

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.

Interventions

None listed

Sponsors

Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Description of intraoperative parameters during cataract surgery when using Active Sentrytime of the surgeryTo 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.

Countries

France

Contacts

Primary ContactAntoine BREZIN, MD, PhD
antoine.brezin@aphp.fr01 58 41 22 01
Backup ContactAlice CAMARA
alice.camara@aphp.fr01 58 41 12 11

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026