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Clinical Trials/NCT01587287
NCT01587287CompletedNot Applicable

A Comprehensive Assessment of the Precision and Agreement of Anterior Corneal Power Measurements Obtained Using Different Devices

Wenzhou Medical University1 site in 1 country35 target enrollmentStarted: April 2011Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
35
Locations
1
Primary Endpoint
Flat corneal power
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

To comprehensively assess the precision and agreement of anterior corneal power measurements using 8 different devices.

Detailed Description

Volunteers with healthy corneas will be measured by different instruments to detect their anterior corneal power. Only the right eye of each subject was selected. Measurements were repeated in the second session scheduled 1 to 2 weeks later.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 55 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •healthy cornea,
  • •best corrected distance visual acuity (BCVA) equal to or better than 20/25,
  • •willing and able to comply with scheduled visits and other study procedures.

Exclusion Criteria

  • •History of refractive surgery or any keratoplasty procedure,
  • •use of contact lenses,
  • •history of corneal dystrophies or degenerative diseases,
  • •history of glaucoma or ocular hypertension,
  • •significant subjective dry eye symptoms, Schirmer I test results of less than 5.0 mm, tear film break-up time shorter than 5 seconds and corneal fluorescein staining positive.

Outcomes

Primary Outcomes

Flat corneal power

Time Frame: 2 weeks

The intrasession repeatability and intersession reproducibility of flat corneal curvature measurements by using the 8 commercially available instruments.

Steep corneal power

Time Frame: 2 weeks

The intrasession repeatability and intersession reproducibility of Steep corneal curvature measurements by using the 8 commercially available instruments.

Secondary Outcomes

  • Vector power J0(2 weeks)
  • Vector power J45(2 weeks)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Yifan Feng

Study Director

Wenzhou Medical University

Study Sites (1)

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