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

A Prospective, Single-Arm, Multicenter, Registry Study to Investigate the Performance of Femtosecond Laser-Assisted Cataract Surgery in Chinese Cataract Patients

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02396719

Enrollment

1541

Registered

2015-03-24

Start date

2015-03-31

Completion date

2016-05-31

Last updated

2016-06-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cataracts

Brief summary

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.

Detailed description

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

Interventions

DEVICELenSx® Laser

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

Study design

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Chinese; * Will undergo LenSx® Laser-assisted cataract surgery and phacoemulsification in at least one eye; * Must sign written informed consent; * Other protocol-specified inclusion criteria may apply.

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; * Other protocol-specified

Design outcomes

Primary

Measure	Time frame
Completion rate of a round anterior capsulotomy	Surgery (Day 0)

Secondary

Measure	Time frame
Completion rate of lens fragmentation without additional segmentation after LenSx Laser procedure	Surgery (Day 0)
Completion rate of intraocular lens (IOL) implantation	Surgery (Day 0)
Completion rate of corneal incisions	Surgery (Day 0)
Best-corrected distance visual acuity (BCDVA)	Up to Day 30
Percentage of patients with BCDVA of 20/20, 20/25, 20/40 or better at each visit	Up to Day 30

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026