A Real-World Registry to Investigate the Performance of LenSx® Laser in Chinese Patients

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

1541 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-03-31

Study Completion Date

2016-05-31

Brief Summary

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The purpose of this study is to investigate the performance of LenSx® Laser in femtosecond laser-assisted cataract surgery (FLACS) in real-world medical practice in Chinese patients.

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Detailed Description

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All subjects will undergo FLACS using the LenSx® Laser system. The recommended postoperative visits will follow the current standard of care in China.

Conditions

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Cataracts

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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LenSx

Phacoemulsification cataract surgery in at least 1 eye using LenSx® Laser technology

LenSx® Laser

Intervention Type DEVICE

Used for cornea incision, capsulotomy and lens fragmentation during cataract surgery

Interventions

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LenSx® Laser

Used for cornea incision, capsulotomy and lens fragmentation during cataract surgery

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Chinese;
* Will undergo LenSx® Laser-assisted cataract surgery and phacoemulsification in at least one eye;
* Must sign written informed consent;

Exclusion Criteria

* Contraindications listed in LenSx® Laser System Operator's Manual;
* Pregnant, nursing, or planning a pregnancy;
* Concurrent enrollment in another investigational drug and/or device study or participation in such a study within 30 days prior to surgery day;

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No