A Comprehensive Assessment of Anterior Corneal Power by Different Devices (No)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yifan Feng, Wenzhou Medical College
ClinicalTrials.gov Identifier:
NCT01587287
First received: April 23, 2012
Last updated: April 28, 2012
Last verified: January 2011

April 23, 2012
April 28, 2012
April 2011
June 2011   (final data collection date for primary outcome measure)
  • Flat corneal power [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    The intrasession repeatability and intersession reproducibility of Steep corneal curvature measurements by using the 8 commercially available instruments.
  • Flat corneal power [ Time Frame: 1 day, 2 weeks ] [ Designated as safety issue: No ]
    The intrasession repeatability (1 day) and intersession reproducibility (2 weeks) of flat corneal curvature measurements by using the 8 commercially available instruments.
  • Steep corneal power [ Time Frame: 1 day, 2 weeks ] [ Designated as safety issue: No ]
    The intrasession repeatability (1 day) and intersession reproducibility (2 weeks) of Steep corneal curvature measurements by using the 8 commercially available instruments.
Complete list of historical versions of study NCT01587287 on ClinicalTrials.gov Archive Site
  • Vector power J0 [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    The intrasession repeatability and intersession reproducibility of vector power J0 measurements by using the 8 commercially available instruments.
  • Vector power J45 [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    The intrasession repeatability and intersession reproducibility of vector power J45 measurements by using the 8 commercially available instruments.
  • Vector power J0 [ Time Frame: 1 day, 2 weeks ] [ Designated as safety issue: No ]
    The intrasession repeatability (1 day) and intersession reproducibility (2 weeks) of vector power J0 measurements by using the 8 commercially available instruments.
  • Vector power J45 [ Time Frame: 1 day, 2 weeks ] [ Designated as safety issue: No ]
    The intrasession repeatability (1 day) and intersession reproducibility (2 weeks) of vector power J45 measurements by using the 8 commercially available instruments.
Not Provided
Not Provided
 
A Comprehensive Assessment of Anterior Corneal Power by Different Devices
A Comprehensive Assessment of the Precision and Agreement of Anterior Corneal Power Measurements Obtained Using Different Devices

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

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

The present study's definitions of reproducibility, repeatability and agreement were based on those adopted by the British Standards Institute and the International Organization for Standardization.

Corneal curvature measurement provides crucial information for calculating intraocular lens power,screening and managing corneal refractive surgeries and corneal disease.

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, at almost the same time as the first session, by the same examiner using the same protocol.

Myopia
Device: Corneal power measurement
All subjects will be underwent a full ophthalmic examination including vision, auto- and subjective refraction, slit-lamp examination, non-contact tonometry, corneal power measurements with the 8 devices and fundus examination.
Other Name: Tomey RC-5000
Corneal power measurement
All recruited volunteers in present study, that underwent corneal power measurement with 8 different instruments
Intervention: Device: Corneal power measurement
Wang Q, Savini G, Hoffer KJ, Xu Z, Feng Y, Wen D, Hua Y, Yang F, Pan C, Huang J. A comprehensive assessment of the precision and agreement of anterior corneal power measurements obtained using 8 different devices. PLoS One. 2012;7(9):e45607. doi: 10.1371/journal.pone.0045607. Epub 2012 Sep 25.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
35
July 2011
June 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01587287
YNKT201101
Yes
Yifan Feng, Wenzhou Medical College
Wenzhou Medical University
Not Provided
Principal Investigator: Yifang Feng, MD Eye Hospital, Wenzhou Medical College, China
Wenzhou Medical University
January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP