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

A Real-World Evidence Study in China Boao Lecheng International Medical Tourism Pilot Zone of the Catalys Precision Laser System (Model: Catalys Precision Laser System)

Patrocinadores

Patrocinador principal: Johnson & Johnson Surgical Vision, Inc.

Fuente Johnson & Johnson Surgical Vision, Inc.
Resumen breve

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.

Estado general Recruiting
Fecha de inicio November 22, 2019
Fecha de Terminación January 31, 2021
Fecha de finalización primaria December 31, 2020
Tipo de estudio Observational
Resultado primario
Medida Periodo de tiempo
Rate of successful anterior capsulotomy Intraoperatively
Rate of successful corneal Incisions Intraoperatively
Rate of successful phacofragmentation as intended Intraoperatively
Inscripción 163
Condición
Intervención

Tipo de intervención: Device

Nombre de intervención: Catalys Precision Laser System

Descripción: Cataract surgeons to create a precise anterior capsulotomy and/or subsequent fragmentation (phacofragmentation) of the crystalline lens using the Catalys Precision Laser System

Etiqueta de grupo de brazo: Catalys Precision Laser System

Elegibilidad

Método de muestreo: Non-Probability Sample

Criterios:

Inclusion Criteria

All criteria apply to each study eye:

Note: Study inclusion and exclusion criteria will be per the Catalys system instructions for use. A few key criteria are listed below:

- Patients scheduled for cataract surgery, including treatment with the Catalys Precision Laser System for anterior capsulotomy, phacofragmentation and the creation of single plane and multi-plane arc cuts/incisions in the cornea.

- Signed informed consent and privacy protection authorization or equivalent documentation necessary to comply with applicable privacy laws pertaining to medical treatment and/or medical record in the governing countries

- At least 22 years of age at the time of consent.ion Criteria

Exclusion Criteria:

All criteria apply to each study eye:

- Presence of corneal ring and/or inlay implant(s), Descemetocele with impending corneal rupture)

- Severe corneal opacities, corneal abnormalities, significant corneal edema, or diminished aqueous clarity that obscures OCT imaging of the anterior lens capsule.

- Any contraindications to cataract surgery

Género: All

Edad mínima: 22 Years

Edad máxima: N/A

Voluntarios Saludables: No

Oficial general
Apellido Papel Afiliación
Sanjeev Kasthurirangan, Ph.D. Study Director Johnson & Johnson Surgical Vision
Contacto general

Apellido: Audrey Jonas

Teléfono: +1 408 273 4073

Email: [email protected]

Ubicación
Instalaciones: Estado: Hainan BoAo Super Hospital
Ubicacion Paises

China

Fecha de verificación

March 2020

Fiesta responsable

Tipo: Sponsor

Tiene acceso ampliado No
Condición Examinar
Grupo de brazo

Etiqueta: Catalys Precision Laser System

Descripción: Cataract Surgery with use of Catalys Precision Laser System

Datos del paciente Yes
Información de diseño del estudio

Modelo de observación: Cohort

Perspectiva de tiempo: Prospective

Fuente: ClinicalTrials.gov