NCT02396719

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,541

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

March 19, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 24, 2015

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

June 6, 2016

Status Verified

June 1, 2016

Enrollment Period

1.2 years

First QC Date

March 19, 2015

Last Update Submit

June 3, 2016

Conditions

Cataracts

Outcome Measures

Primary Outcomes (1)

  • Completion rate of a round anterior capsulotomy

    Surgery (Day 0)

Secondary Outcomes (5)

  • 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

Study Arms (1)

LenSx

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

Device: LenSx® Laser

Interventions

LenSx® LaserDEVICE

Used for cornea incision, capsulotomy and lens fragmentation during cataract surgery

LenSx

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • Chinese;
  • Will undergo LenSx® Laser-assisted cataract surgery and phacoemulsification in at least one eye;
  • Must sign written informed consent;

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alcon China Ophthalmic Product Co., Ltd.

Beijing, 100016, China

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Study Officials

  • Zuojun Gao, Medical Affairs Director

    Alcon China

    STUDY DIRECTOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 19, 2015

First Posted

March 24, 2015

Study Start

March 1, 2015

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

June 6, 2016

Record last verified: 2016-06

Locations

CN(1)