Tear Film Evaluation After Phacoemulsification | NCT02238015

Studies
Tear Film Evaluation After Phacoemulsification

NCT02238015

Sponsor

Zheng Qian

Status

Unknown status

Last Update Posted

Sep 12, 2014Estimated

Enrollment

60Estimated

Phase

Not provided

Conditions

Cortical Senile Cataract

Interventions

cataract surgery

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

Sep 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2013

Primary Completion Date

May 2014Actual

Completion Date

Mar 2015Estimated

First Submitted Date

Aug 28, 2014

First Submission Date that Met QC Criteria

Sep 11, 2014

First Posted Date

Sep 12, 2014Estimated

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

Sep 11, 2014

Last Update Posted Date

Sep 12, 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

To compare tear film differences between surgical eyes and nonsurgical eyes in patients who had cataract surgery by phacoemulsification in one eye.

Detailed Description

All participants granted their written informed consent to participate in the research protocol.

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

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
surgery group		patients underwent cataract surgery with 3.0 mm clear corneal incision at 11 o'clock in one eye	Procedure: cataract surgery
control group		patients' other eye that did not have surgery

Interventions

Name	Type	Description	Arm Group Labels	Other Names
cataract surgery	Procedure	All patients underwent cataract surgery with 3.0 mm clear corneal incision at 11 o'clock in one eye	surgery group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Phacoemulsification influence on the postoperative tear functions		1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

age-related cataract without surgery history and dry eye symptoms history

Exclusion Criteria:

diseases influencing tear secretion (such as Sjögren syndrome, Steve-Johnson syndrome, diabetes, thyroid disease, etc.); history of ocular surgeries or nuclear hardness IV and V, which required the use of larger phacoemulsification energy; use of drugs that affect tear secretion and stability (such as glaucoma medications, artificial tears, corticosteroid drugs, etc.); or presence of ocular diseases (such as Pterygium, blepharitis, uveitis, glaucoma, lacrimal apparatus, etc.).

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

45 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

60 eyes from 30 age-related cataract participants underwent cataract surgery with 3.0 mm clear corneal incision at 11 o'clock in one eye and the other eye without surgery history

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Qian Zheng, MD	Contact	18367839685		zq15.04@163.com

Overall Officials

Name	Affiliation	Role
Qian Zheng, MD	Wenzhou Medical University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Wenzhou Medical University	Recruiting	Wenzhou	Zhejiang	325027	China

Intervention Browse Module

MeSH Terms

ID	Term
D002387	Cataract Extraction

Ancestor Terms

ID	Term
D054140	Refractive Surgical Procedures
D013508	Ophthalmologic Surgical Procedures
D013514	Surgical Procedures, Operative

Browse Leaves

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Browse Branches

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