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Completed

NCT Number: NCT01587287

A Comprehensive Assessment of Anterior Corneal Power by Different Devices

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

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Key information

Conditions

Myopia Eye Diseases Refractive Errors

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Wenzhou Medical College

Wenzhou, Zhejiang, 325000, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Corneal power measurement

Device

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 names: Tomey RC-5000

Primary outcomes

  1. 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.

  2. 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

  1. Vector power J0

    Time frame: 2 weeks

    The intrasession repeatability and intersession reproducibility of vector power J0 measurements by using the 8 commercially available instruments.

  2. Vector power J45

    Time frame: 2 weeks

    The intrasession repeatability and intersession reproducibility of vector power J45 measurements by using the 8 commercially available instruments.

Sponsors and collaborators

Lead sponsor

Wenzhou Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Apr 30, 2012
Registry last updated
May 1, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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