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

NCT04171518 | Completed FDA Device

• 1 other identifier: CAST-102-SYST
• Study Type: observational
• Target: 139
• Locations: 1 country
• Sites: 1

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.

Conditions

Cataract

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

Catalys Precision Laser System

Cataract Surgery with use of Catalys Precision Laser System

Device: Catalys Precision Laser System

Interventions

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

Catalys Precision Laser System

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• All criteria apply to each study eye:

You may not qualify if:

• 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

Sponsors & Collaborators

• Johnson & Johnson Surgical Vision, Inc.: lead

Study Sites (1)

Hainan BoAo Super Hospital

BoAo, Hainan, China

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Study Officials

• Sanjeev Kasthurirangan, Ph.D.

  Johnson & Johnson Surgical Vision

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2019
• First Posted: November 21, 2019
• Study Start: November 22, 2019
• Primary Completion: October 12, 2020
• Study Completion: October 12, 2020
• Last Updated: November 30, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)