A Real-World Registry to Investigate the Performance of L... | NCT02396719

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

NCT02396719

Sponsor

Alcon Research

Status

Completed

Last Update Posted

Jun 6, 2016Estimated

Enrollment

1,541Actual

Phase

Not provided

Conditions

Cataracts

Interventions

LenSx® Laser

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2015

Primary Completion Date

May 2016Actual

Completion Date

May 2016Actual

First Submitted Date

Mar 19, 2015

First Submission Date that Met QC Criteria

Mar 19, 2015

First Posted Date

Mar 24, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 3, 2016

Last Update Posted Date

Jun 6, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,541Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
LenSx		Phacoemulsification cataract surgery in at least 1 eye using LenSx® Laser technology	Device: LenSx® Laser

Interventions

Name	Type	Description	Arm Group Labels	Other Names
LenSx® Laser	Device	Used for cornea incision, capsulotomy and lens fragmentation during cataract surgery	LenSx

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Completion rate of a round anterior capsulotomy		Surgery (Day 0)

Secondary Outcomes

Measure	Description	Time Frame
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)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Zuojun Gao, Medical Affairs Director	Alcon China	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Alcon China Ophthalmic Product Co., Ltd.		Beijing		100016	China

Condition Browse Module

MeSH Terms

ID	Term
D002386	Cataract

Ancestor Terms

ID	Term
D007905	Lens Diseases
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided