Comparison of Manual Super Small Incision Cataract Surger... | NCT01146964

Studies
Comparison of Manual Super Small Incision Cataract Surgery and Phacoemulsification

NCT01146964

Sponsor

Wenzhou Medical University

Status

Completed

Last Update Posted

Jan 3, 2014Estimated

Enrollment

100Actual

Phase

Not Applicable

Conditions

Cataract
Phacoemulsification

Interventions

MSSICS
Phacoemulsification

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

Jan 2014

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

May 2010

Primary Completion Date

Jun 2011Actual

Completion Date

Jun 2011Actual

First Submitted Date

Jun 2, 2010

First Submission Date that Met QC Criteria

Jun 17, 2010

First Posted Date

Jun 22, 2010Estimated

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

Jan 2, 2014

Last Update Posted Date

Jan 3, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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 compare the safety and efficacy of manual super small incision cataract surgery (MSSICS) and Phacoemulsification.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Phacoemulsification, Safety, Efficacy	Experimental		Procedure: Phacoemulsification
MSSICS, Safety, Efficacy	Experimental		Procedure: MSSICS

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MSSICS	Procedure	Manual super small incision cataract surgery	MSSICS, Safety, Efficacy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Corneal endothelial cell loss		3 months postoperatively

Secondary Outcomes

Measure	Description	Time Frame
postoperative astigmatism		3 months postoperatively
visual acuity		3 month postoperatively

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age related cataract patients
Cataract density grade II-III according to the Emery-Little system classification system

Exclusion Criteria:

Legal guardian(s) is/are not present for permission
Other eye diseases impairing visual acuity (ie. glaucoma)
patients with severe systemic diseases not good for ocular surgery

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Wei Chen, MD, PhD	Eye Hospital, Wenzhou Medical College, China	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Eye Hospital, Wenzhou Medical College		Wenzhou	Zhejiang	325027	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

Intervention Browse Module

MeSH Terms

ID	Term
D018918	Phacoemulsification

Ancestor Terms

ID	Term
D002387	Cataract Extraction
D054140	Refractive Surgical Procedures
D013508	Ophthalmologic Surgical Procedures
D013514	Surgical Procedures, Operative

Browse Leaves

Not provided

Browse Branches

Not provided