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

Alcon Research1,541 enrolled

Overview

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.

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

Study Type

OBSERVATIONAL

Enrollment

1,541

Conditions

Cataracts

Interventions

LenSx® LaserDEVICE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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 exclusion criteria may apply.

Locations (1)

Alcon China Ophthalmic Product Co., Ltd.

Beijing, China

Outcomes

Primary Outcomes

Completion rate of a round anterior capsulotomy

Time frame: Surgery (Day 0)

Secondary Outcomes

Completion rate of lens fragmentation without additional segmentation after LenSx Laser procedure

Time frame: Surgery (Day 0)

Completion rate of intraocular lens (IOL) implantation

Time frame: Surgery (Day 0)

Completion rate of corneal incisions

Time frame: Surgery (Day 0)

Best-corrected distance visual acuity (BCDVA)

Time frame: Up to Day 30

Percentage of patients with BCDVA of 20/20, 20/25, 20/40 or better at each visit

Time frame: Up to Day 30

Data from ClinicalTrials.gov

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