NCT01636167

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2011

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 29, 2012

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 10, 2012

Completed
Last Updated

July 10, 2012

Status Verified

July 1, 2012

Enrollment Period

5 months

First QC Date

June 29, 2012

Last Update Submit

July 9, 2012

Conditions

Corneal AstigmatismOrientation

Outcome Measures

Primary Outcomes (1)

  • axis of astigmatism

    day 1

Secondary Outcomes (1)

  • axis of implantation

    day 1

Interventions

computerized intraoperative keratomerDEVICE

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

Also known as: Experimental: computerized intraoperative keratomer

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Cornea astigmatism from -1.0 D to -4.0D;

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wenzhou Medical College

Wenzhou, Zhejiang, 325000, China

Location

MeSH Terms

Conditions

AstigmatismOrientation, Spatial

Condition Hierarchy (Ancestors)

Refractive ErrorsEye DiseasesSpatial BehaviorBehavior

Study Officials

  • YU A YONG

    Wenzhou Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

June 29, 2012

First Posted

July 10, 2012

Study Start

July 1, 2011

Primary Completion

December 1, 2011

Study Completion

May 1, 2012

Last Updated

July 10, 2012

Record last verified: 2012-07

Locations

CN(1)