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

Sponsor
Alcon Research (Industry)
Overall Status
Completed
CT.gov ID
NCT02396719
Collaborator
(none)
1,541
Enrollment
1
Location
14
Duration (Months)
109.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Actual Enrollment :
1541 participants
Time Perspective:
Prospective
Official Title:
A Prospective, Single-Arm, Multicenter, Registry Study to Investigate the Performance of Femtosecond Laser-Assisted Cataract Surgery in Chinese Cataract Patients
Study Start Date :
Mar 1, 2015
Actual Primary Completion Date :
May 1, 2016
Actual Study Completion Date :
May 1, 2016

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Completion rate of a round anterior capsulotomy [Surgery (Day 0)]

Secondary Outcome Measures

  1. Completion rate of lens fragmentation without additional segmentation after LenSx Laser procedure [Surgery (Day 0)]

  2. Completion rate of intraocular lens (IOL) implantation [Surgery (Day 0)]

  3. Completion rate of corneal incisions [Surgery (Day 0)]

  4. Best-corrected distance visual acuity (BCDVA) [Up to Day 30]

  5. Percentage of patients with BCDVA of 20/20, 20/25, 20/40 or better at each visit [Up to Day 30]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Alcon China Ophthalmic Product Co., Ltd. Beijing China 100016

Sponsors and Collaborators

  • Alcon Research

Investigators

  • Study Director: Zuojun Gao, Medical Affairs Director, Alcon China

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Alcon Research
ClinicalTrials.gov Identifier:
NCT02396719
Other Study ID Numbers:
  • CTO130-P001
First Posted:
Mar 24, 2015
Last Update Posted:
Jun 6, 2016
Last Verified:
Jun 1, 2016
Additional relevant MeSH terms:
Cataract

Study Results

No Results Posted as of Jun 6, 2016