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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | December 21, 2007 | ||||
| Last Updated Date | December 21, 2007 | ||||
| Start Date ICMJE | November 2007 | ||||
| Estimated Primary Completion Date | December 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
There will be no inter-patient comparison. Bearing and elevation fluorescein patterns will be compared between the actual (photo) and theoretical (computer generated) fluorescein patterns. [ Time Frame: 1 year after last subject is enrolled ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE |
Improved comfort [ Time Frame: one day ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Corneal Topographer Fluorescein Patterns | ||||
| Official Title ICMJE | Objective and Subjective Correlation Between Clinical Fluoroscein Patterns and Theoretical Patterns Using the Medmont Corneal Topographer | ||||
| Brief Summary | The objective of this study is to determine if corneal topography can be used to predict the fluorescein pattern of keratoconus lenses on the eye. A corneal topography image will be taken and the computer selected lens will be placed on the eye. After placement of the lens color photographs will be taken of the eye's fluorescein pattern and compared to the computer predicted pattern. |
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| Detailed Description | Subject population: keratoconus patients who have not undergone corneal surgery 100 subjects who come to UIHC for their contact lens care. We will approach them at their visit. We will not call potential participants from a database. If topography is impossible to capture. Concommitant Corneal Disease Minors will be excluded |
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| Study Phase | |||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Supportive Care, Open Label, Single Group Assignment | ||||
| Condition ICMJE | Keratoconus | ||||
| Intervention ICMJE | Other: Comparison of fluorescein patterns | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 0 | ||||
| Completion Date | |||||
| Estimated Primary Completion Date | December 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria: 18yrs of age or older diagnosis of keratoconus contact lens wearer Exclusion Criteria: Concommittant corneal disease or surgery Inability to capture topography measurement |
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00584285 | ||||
| Responsible Party | Christine Sindt, OD, University of Iowa | ||||
| Study ID Numbers ICMJE | 200709737 | ||||
| Study Sponsor ICMJE | University of Iowa | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | University of Iowa | ||||
| Verification Date | December 2007 | ||||
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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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