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

Cataract Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04171518
• Other study ID #: CAST-102-SYST
• Status: Completed
• Start date: November 22, 2019
• Est. completion date: October 12, 2020

Study information

• Verified date: November 2021
• Source: Johnson & Johnson Surgical Vision, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 139
• Est. completion date: October 12, 2020
• Est. primary completion date: October 12, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cataract

Intervention

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

Locations

Country	Name	City	State
China	Hainan BoAo Super Hospital	BoAo	Hainan

Sponsors (1)

Lead Sponsor	Collaborator
Johnson & Johnson Surgical Vision, Inc.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of successful anterior capsulotomy	If the investigator is able to remove the capsular disc from the peripheral capsule without the need of manual separation of residual tags, then it will be considered a complete capsulotomy.	Intraoperatively
Primary	Rate of successful corneal Incisions	If the investigator is able to blunt dissect the primary incision (without the need for a secondary cutting instrument), then it will be considered a complete cut.	Intraoperatively
Primary	Rate of successful phacofragmentation as intended	If there are no error messages or treatment interruptions occur, then phacofragmentation will be considered complete.	Intraoperatively