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

Completed

• Conditions: Cataract
• Interventions: Device: Catalys Precision Laser System

• Registration Number: NCT04171518
• Lead Sponsor: Johnson & Johnson Surgical Vision, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-11-19
• Study First Submitted QC: 2019-11-19
• Study First Posted: 2019-11-21
• Study Start: 2019-11-22
• Primary Completion: 2020-10-12
• Study Completion: 2020-10-12
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-29
• Last Update Posted: 2021-11-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 139

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Catalys Precision Laser System	Catalys Precision Laser System	Cataract Surgery with use of Catalys Precision Laser System

Primary Outcome Measures

Name	Time	Method
Rate of successful anterior capsulotomy	Intraoperatively	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.
Rate of successful corneal Incisions	Intraoperatively	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.
Rate of successful phacofragmentation as intended	Intraoperatively	If there are no error messages or treatment interruptions occur, then phacofragmentation will be considered complete.

Trial Locations

Locations (1)

Hainan BoAo Super Hospital; 🇨🇳 BoAo, Hainan, China