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NCT04171518

A Real-World Evidence Study in China of the Catalys Precision Laser System

Completed Last updated 30 November 2021
What this trial tests

trial testing Catalys Precision Laser System in Cataract in 139 participants. Completed in 12 October 2020.

Timeline
22 November 2019
Primary endpoint
12 October 2020
12 October 2020

Quick facts

Lead sponsorJohnson & Johnson Surgical Vision, Inc.
StatusCompleted
Study typeOBSERVATIONAL
Enrollment139
Start date22 November 2019
Primary completion12 October 2020
Estimated completion12 October 2020
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

Johnson & Johnson Surgical Vision, Inc. — full company profile →

Who can join

22 and older, any sex, with Cataract. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study is a prospective, single-arm, observational study of the Catalys Precision Laser System in real-world clinical practice. The study will be conducted at one site at the Boao Super Hospital in Lecheng International Medical Tourism Pilot Zone of Hainan province in China. The study is being conducted to evaluate the overall performance of the Catalys Precision Laser System. One or both eyes of each subject will be included in study. The Catalys system is used as part of cataract surgery to create LASER cuts as intended by the surgeon to aid in cataract surgery, without adversely impacting the risk to the patient.As such, the endpoints of surgeon rating of completeness of corneal incisions, anterior capsulotomy and phacofragmentation and any device related adverse events from the time of Catalys System use to 1-month postoperative follow-up should adequately cover the evaluation of the intended use of the Catalys System.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Other recruiting trials for Cataract

Currently open trials in the same condition.

Other Johnson & Johnson Surgical Vision, Inc. trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04171518.

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