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

Johnson & Johnson (J&J)

Status: Completed

Conditions: Cataract

Treatments: Device: Catalys Precision Laser System

Study type: Observational

Funder types: Industry

Identifiers

NCT04171518

CAST-102-SYST

Details and patient eligibility

About

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.

Enrollment: 139 patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

139 participants in 1 patient group

Catalys Precision Laser System

Description:

Cataract Surgery with use of Catalys Precision Laser System

Treatment:

Device: Catalys Precision Laser System