Construction of Computerized Intraoperative Keratometer and Experimental Study

Corneal Astigmatism Clinical Trial

Official title:

Construction of Computerized Intraoperative Keratometer and Experimental Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01636167
• Other study ID #: Astigmatism
• Status: Completed
• Phase: N/A
• First received: June 29, 2012
• Last updated: July 9, 2012
• Start date: July 2011
• Est. completion date: May 2012

Study information

• Verified date: July 2012
• Source: Wenzhou Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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;

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Astigmatism
• Corneal Astigmatism
• Orientation

Intervention

Device:
• computerized intraoperative keratomer
computerized intraoperative keratomer can analyze the axis of corneal astigmatism accurately as well as rapidly by self-designed software during surgery

Locations

Country	Name	City	State
China	Wenzhou Medical College	Wenzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Wenzhou Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	axis of astigmatism		day 1	No
Secondary	axis of implantation		day 1	No