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

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.

Study Overview

• Status: Completed
• Conditions: Cataracts
• Intervention / Treatment: Device: LenSx® Laser

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.

• Study Type: Observational
• Enrollment (Actual): 1541

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100016
    • Alcon China Ophthalmic Product Co., Ltd.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Chinese patients who undergo cataract surgery using LenSx® Laser and phacoemulsification in at least one eye will be eligible to participate.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
LenSx; Phacoemulsification cataract surgery in at least 1 eye using LenSx® Laser technology	Device: LenSx® Laser; Used for cornea incision, capsulotomy and lens fragmentation during cataract surgery

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Alcon Research
• Investigators: Study Director: Zuojun Gao, Medical Affairs Director, Alcon China

Study record dates

Study Major Dates

• Study Start: March 1, 2015
• Primary Completion (Actual): May 1, 2016
• Study Completion (Actual): May 1, 2016

Study Registration Dates

• First Submitted: March 19, 2015
• First Submitted That Met QC Criteria: March 19, 2015
• First Posted (Estimate): March 24, 2015

Study Record Updates

• Last Update Posted (Estimate): June 6, 2016
• Last Update Submitted That Met QC Criteria: June 3, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: CTO130-P001