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

Completed

• Conditions: Cataracts
• Interventions: Device: LenSx® Laser

• Registration Number: NCT02396719
• Lead Sponsor: Alcon Research

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.

Study Timeline

• Study Start: 2015-03
• Study First Submitted: 2015-03-19
• Study First Submitted QC: 2015-03-19
• Study First Posted: 2015-03-24
• Primary Completion: 2016-05
• Study Completion: 2016-05
• Status Verified: 2016-06
• Last Update Submitted: 2016-06-03
• Last Update Posted: 2016-06-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1541

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Completion rate of a round anterior capsulotomy	Surgery (Day 0)

Secondary Outcome Measures

Name	Time	Method
Completion rate of lens fragmentation without additional segmentation after LenSx Laser procedure	Surgery (Day 0)
Completion rate of corneal incisions	Surgery (Day 0)
Completion rate of intraocular lens (IOL) implantation	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

Trial Locations

Locations (1)

Alcon China Ophthalmic Product Co., Ltd.; 🇨🇳 Beijing, China