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Construction of Computerized Intraoperative Keratometer and Experimental Study

Primary Purpose

Corneal Astigmatism, Orientation

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
computerized intraoperative keratomer
Sponsored by
Wenzhou Medical University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional health services research trial for Corneal Astigmatism

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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;

Sites / Locations

  • Wenzhou Medical College

Outcomes

Primary Outcome Measures

axis of astigmatism

Secondary Outcome Measures

axis of implantation

Full Information

First Posted
June 29, 2012
Last Updated
July 9, 2012
Sponsor
Wenzhou Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT01636167
Brief Title
Construction of Computerized Intraoperative Keratometer and Experimental Study
Official Title
Construction of Computerized Intraoperative Keratometer and Experimental Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
May 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wenzhou Medical University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Corneal Astigmatism, Orientation

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
computerized intraoperative keratomer
Other Intervention Name(s)
Experimental: computerized intraoperative keratomer
Intervention Description
computerized intraoperative keratomer can analyze the axis of corneal astigmatism accurately as well as rapidly by self-designed software during surgery
Primary Outcome Measure Information:
Title
axis of astigmatism
Time Frame
day 1
Secondary Outcome Measure Information:
Title
axis of implantation
Time Frame
day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
YU A YONG
Organizational Affiliation
Wenzhou Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wenzhou Medical College
City
Wenzhou
State/Province
Zhejiang
ZIP/Postal Code
325000
Country
China

12. IPD Sharing Statement

Learn more about this trial

Construction of Computerized Intraoperative Keratometer and Experimental Study

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