Registry of PHAcoemulsification for Cataract Surgery

NCT06659419 | Recruiting

• 1 other identifier: APHP240817
• Study Type: observational
• Target: 100,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Cataract

Keywords

Cataract; Surgery; Phacoemulsification

Outcome Measures

Primary Outcomes (1)

• Description of intraoperative parameters during cataract surgery when using Active Sentry

  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.

  time of the surgery

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

No patient but procedures recorded in Centurions machine.

You may qualify if:

• \- All procedures recorded in Centurions (200 machines).

You may not qualify if:

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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Ophthalmology department - Cochin Hospital

Paris, 75014, France

RECRUITING

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Study Officials

• Antoine BREZIN, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Antoine BREZIN, MD, PhD

CONTACT

01 58 41 22 01; antoine.brezin@aphp.fr

Alice CAMARA

CONTACT

01 58 41 12 11; alice.camara@aphp.fr

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2024
• First Posted: October 26, 2024
• Study Start: October 1, 2024
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: January 22, 2025

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)