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

NCT ID: NCT04171518

Last Updated: 2021-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

139 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-11-22

Study Completion Date

2020-10-12

Brief Summary

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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

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Conditions

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Cataract

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Catalys Precision Laser System

Cataract Surgery with use of Catalys Precision Laser System

Catalys Precision Laser System

Intervention Type DEVICE

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

Interventions

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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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

All criteria apply to each study eye:

Exclusion Criteria

* 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


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
Minimum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Johnson & Johnson Surgical Vision, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sanjeev Kasthurirangan, Ph.D.

Role: STUDY_DIRECTOR

Johnson & Johnson Surgical Vision

Locations

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Hainan BoAo Super Hospital

BoAo, Hainan, China

Site Status

Countries

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China

Other Identifiers

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CAST-102-SYST

Identifier Type: -

Identifier Source: org_study_id