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

Cataracts Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02396719
• Other study ID #: CTO130-P001
• Status: Completed
• Phase: N/A
• First received: March 19, 2015
• Last updated: June 3, 2016
• Start date: March 2015
• Est. completion date: May 2016

Study information

• Verified date: June 2016
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Observational

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1541
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Time Perspective: Prospective

Related Conditions & MeSH terms

• Cataract
• Cataracts

Intervention

Device:
• LenSx® Laser
Used for cornea incision, capsulotomy and lens fragmentation during cataract surgery

Locations

Country	Name	City	State
China	Alcon China Ophthalmic Product Co., Ltd.	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Completion rate of a round anterior capsulotomy		Surgery (Day 0)	No
Secondary	Completion rate of lens fragmentation without additional segmentation after LenSx Laser procedure		Surgery (Day 0)	No
Secondary	Completion rate of intraocular lens (IOL) implantation		Surgery (Day 0)	No
Secondary	Completion rate of corneal incisions		Surgery (Day 0)	No
Secondary	Best-corrected distance visual acuity (BCDVA)		Up to Day 30	No
Secondary	Percentage of patients with BCDVA of 20/20, 20/25, 20/40 or better at each visit		Up to Day 30	No