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

Study Overview
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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.

Official Title
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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)

Conditions
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Cataract

Intervention / Treatment
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* Device: Catalys Precision Laser System


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 22 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Catalys Precision Laser System<br>Cataract Surgery with use of Catalys Precision Laser System | Device: Catalys Precision Laser System<br>* Cataract surgeons to create a precise anterior capsulotomy and/or subsequent fragmentation (phacofragmentation) of the crystalline lens using the Catalys Precision Laser System<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 |