A Real-World Evidence Study in China of the Catalys Preci... | NCT04171518

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

NCT04171518

Sponsor

Johnson & Johnson Surgical Vision, Inc.

Status

Completed

Last Update Posted

Nov 30, 2021Actual

Enrollment

139Actual

Phase

Not provided

Conditions

Cataract

Interventions

Catalys Precision Laser System

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 22, 2019Actual

Primary Completion Date

Oct 12, 2020Actual

Completion Date

Oct 12, 2020Actual

First Submitted Date

Nov 19, 2019

First Submission Date that Met QC Criteria

Nov 19, 2019

First Posted Date

Nov 21, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 29, 2021

Last Update Posted Date

Nov 30, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

139Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Catalys Precision Laser System		Cataract Surgery with use of Catalys Precision Laser System	Device: Catalys Precision Laser System

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Catalys Precision Laser System	Device	Cataract surgeons to create a precise anterior capsulotomy and/or subsequent fragmentation (phacofragmentation) of the crystalline lens using the Catalys Precision Laser System

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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
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
Rate of successful phacofragmentation as intended	If there are no error messages or treatment interruptions occur, then phacofragmentation will be considered complete.	Intraoperatively

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

22 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

This study will include subjects undergoing primary cataract extraction and IOL implantation and who meet all the study inclusion and exclusion criteria. Subjects treated during the period of November 2019 to March 2020 (that satisfy the protocol inclusion and exclusion criteria) may be included in the study, or a maximum of 163 subjects (not including the subjects for surgeon certification), whichever comes first. One or both eyes of each subject will be included in study.

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Sanjeev Kasthurirangan, Ph.D.	Johnson & Johnson Surgical Vision	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Hainan BoAo Super Hospital		BoAo	Hainan		China

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Johnson & Johnson Medical Devices Companies have an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA project site at http://yoda.yale.edu

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

http://yoda.yale.edu

ID	Term
D007905	Lens Diseases
D005128	Eye Diseases