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

Alcon

Status: Completed

Conditions: Cataracts

Treatments: Device: LenSx® Laser

Study type: Observational

Funder types: Industry

Identifiers

NCT02396719

CTO130-P001

Details and patient eligibility

About

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.

Full description

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

Enrollment: 1,541 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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 exclusion criteria may apply.

Trial design

1,541 participants in 1 patient group

LenSx

Description:

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

Treatment:

Device: LenSx® Laser