Construction of Computerized Intraoperative Keratometer a... | NCT01636167

Studies
Construction of Computerized Intraoperative Keratometer and Experimental Study

NCT01636167

Sponsor

Wenzhou Medical University

Status

Completed

Last Update Posted

Jul 10, 2012Estimated

Enrollment

60Actual

Phase

Not Applicable

Conditions

Corneal Astigmatism
Orientation

Interventions

computerized intraoperative keratomer

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

Jul 2012

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

Jul 2011

Primary Completion Date

Dec 2011Actual

Completion Date

May 2012Actual

First Submitted Date

Jun 29, 2012

First Submission Date that Met QC Criteria

Jul 9, 2012

First Posted Date

Jul 10, 2012Estimated

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

Jul 9, 2012

Last Update Posted Date

Jul 10, 2012Estimated

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 construct a computerized intraoperative keratometer to analyze the axis of corneal astigmatism accurately as well as rapidly by self-designed software during surgery.

Detailed Description

The study is designed to construct a computerized intraoperative keratometer to analyze the axis of corneal astigmatism accurately as well as rapidly by self-designed software during surgery.

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

60Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
computerized intraoperative keratomer	Device	computerized intraoperative keratomer can analyze the axis of corneal astigmatism accurately as well as rapidly by self-designed software during surgery		Experimental: computerized intraoperative keratomer

Measure	Description	Time Frame
axis of astigmatism		day 1

Measure	Description	Time Frame
axis of implantation		day 1

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Cornea astigmatism from -1.0 D to -4.0D;

Exclusion Criteria:

any significant corneal disease
Other eye diseases induces impaired vision ,such as retinal detachment,keratoconus,pterygium,glaucoma,choroidal detachment,vitreous hemorrhage,congenital cataract,lens dislocation,anterior uveitis ,pupil deformation and so on;
Previous corneal or intraocular surgery;
Refuse surgery;

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
YU A YONG	Wenzhou Medical University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Wenzhou Medical College		Wenzhou	Zhejiang	325000	China

Condition Browse Module

MeSH Terms

ID	Term
D001251	Astigmatism
D000072458	Orientation, Spatial

Ancestor Terms

ID	Term
D012030	Refractive Errors
D005128	Eye Diseases
D013037	Spatial Behavior
D001519	Behavior

Browse Leaves

Not provided

Browse Branches

Not provided