A Comprehensive Assessment of Anterior Corneal Power by Different Devices (No)
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| First Received Date ICMJE | April 23, 2012 | ||||
| Last Updated Date | April 28, 2012 | ||||
| Start Date ICMJE | April 2011 | ||||
| Primary Completion Date | June 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE |
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| Change History | Complete list of historical versions of study NCT01587287 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | A Comprehensive Assessment of Anterior Corneal Power by Different Devices | ||||
| Official Title ICMJE | A Comprehensive Assessment of the Precision and Agreement of Anterior Corneal Power Measurements Obtained Using Different Devices | ||||
| Brief Summary | To comprehensively assess the precision and agreement of anterior corneal power measurements using 8 different devices. |
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| 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. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | 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. |
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| Condition ICMJE | Myopia | ||||
| Intervention ICMJE | 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 |
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| Study Group/Cohort (s) | Corneal power measurement
All recruited volunteers in present study, that underwent corneal power measurement with 8 different instruments
Intervention: Device: Corneal power measurement |
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| Publications * | 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. | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 35 | ||||
| Completion Date | July 2011 | ||||
| Primary Completion Date | June 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 55 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | China | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01587287 | ||||
| Other Study ID Numbers ICMJE | YNKT201101 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Yifan Feng, Wenzhou Medical College | ||||
| Study Sponsor ICMJE | Wenzhou Medical College | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Wenzhou Medical College | ||||
| Verification Date | January 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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